MAR 2 3 ZOOfi SUMMARY OF SAFETY AND EFFECTIVENESS ... - FDA [PDF]

Records processed under FOIA Request # 2015-2557; Released by CDRH on 10-06-2015

MAR 2 3 ZOOfi SUMMARY OF SAFETY AND EFFECTIVENESS NAME OF FIRM:

DePuy Orthopaedics Inc. 700 Orthopaedic Drive Warsaw, Indiana 46581-0988 EST REGNo.: 1818910

SIO(K) CONTACT:

Steve Wentworth Regulatory Affairs Manager Tel: (574) 371-4913 Fax: (574) 371-4987

TRADE NAME: COMMON NAME:

DePuy PFC® Sigma Knee Prosthesis Tricompartmental Knee Prosthesis

CLASSIFICATION:

Knee joint patellofemorotibial, polymer/metal/polymer semiconstrained cemented prosthesis (21 CFR 888.3560), Class II Device

DEVICE PRODUCT CODE:

JWH

SUBSTANTIALLY EQUIVALENT DEVICES:

DePuy LPS Metaphyseal Sleeve Component (K040281, cleared July 9, 2004) Darwin Knee System (TC3) (K952830, cleared January 18, 1996)

DEVICE DESCRIPTION:

The DePuy Sigma Femoral Adapters are a modification to the previously cleared DePuy PFC Sigma Femoral Adapters included in K040281. The devices consist of a selection of adapters and bolts that attach to Sigma TC3 and C/S femoral components' intracondylar boxes. When assembled to a femoral component, they provide a construct for the attachment of additional fixation extensions such as metaphyseal sleeves or cemented and fluted stern extensions. The Sigma Femoral Adapters are available in five and seven degree valgus angle options and +2 rnrn, 0 rnrn, and -2 rnrn anterior/posterior offset options. INDICATIONS FOR USE:

The PFC® Sigma Total Knee Prosthesis is intended for use in total knee replacement surgery for patients suffering from severe pain and disability due to permanent structural damage resulting from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, pseudogout, trauma or failed prior surgical intervention. The PFC Sigma Total Knee Prosthesis is intended for cemented use only.

0000(}06 Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Records processed under FOIA Request # 2015-2557; Released by CDRH on 10-06-2015

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BASIS FOR SUBSTANTIAL EQUIVALENCE:

The design of the PFC Sigma Knee Prosthesis Femoral Adapter is substantially equivalent to the LPS Metaphyseal Sleeve (K040281) and the Darwin Knee System (TC3) (K952830). The materials used for the subject device components are identical to those for the predicated devices and the design of the attachment mechanism incorporates similar adapter, retaining ring and bolt components. The available offset options (2mm anterior, neutral, 2mm posterior) are the same for the PFC Sigma and the predicate devices. Both the PFC Sigma and Darwin Knee systems offer 5° 0 0 and 7 valgus angle components, whereas the LPS system offers only a 5 valgus angle component. Based upon the similarities in the design, the equivalent materials utilized and the results from the mechanical testing of the PFC Sigma Femoral Adapter, DePuy believes this device to be substantially equivalent to other commercially available devices.

0000007 Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Records processed under FOIA Request # 2015-2557; Released by CDRH on 10-06-2015

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 3 2006

DePuy Orthopaedics, Inc. c/o Mr. Steven J. Wentworth Regulatory Affairs Project Manager P.O. Box 988 700 Orthopaedic Drive Warsaw, Indiana 46581-0988 Re: K060515 Trade/Device Name: DePuy Sigma Knee Femoral Adapter Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: JWH Dated: February 24, 2006 Received: February 27, 2006 Dear Mr. Wentworth: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Records processed under FOIA Request # 2015-2557; Released by CDRH on 10-06-2015

Page 2- Mr. Steven J. Wentworth comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 80 I); good manufacturing practice requirements as c:ct forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR I 000-1050. This letter will allow you to begin marketing your device as described in your Section 51 O(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 80 I), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmalclsmamain.html

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Records processed under FOIA Request # 2015-2557; Released by CDRH on 10-06-2015

Indications for lise Statement

510(k) Number (if known):

KObC71"7

Device Name: DePuy Sigma Knee Femoral Adapter

Intended Use and Indications: The PFC® Sigma Total Knee Prosthesis is intended for use in total knee replacement surgery for patients suffering from severe pain and disability due to permanent structural damage resulting from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, pseudogout, trauma or failed prior surgical intervention. The PFC Sigma Total Knee Prosthesis is intended for cemented use only.

/

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use·--(21 CFR 807 Subpart C)

Concurrence of CDRH, Office of Device Evaluation (ODE)

d~~~_,ery for patients suffering from severe pain and disability due to permanent structural damage rr .•;ulting from rheumatoid anhritis, osteoarthritis, post-traumatic arthritis, collagen disorders, pseudogout, trauma or failed prior surgical intervention. The PFC Sigma Total Knee Prosthesis is inte>Jded for cemented use only.

/

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use ___ (21 CFR 807 Subpart C)

Concurrence of CDRH, Office of Device Evaluation (ODE)

~~:;::~·f}_ (Diviston gn- .m Division of General, Res.ftJfdVf and Neurological Devices

SlO(k) Number Ko~ vSI 5

0000008 Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Records processed under FOIA Request # 2015-2557; Released by CDRH on 10-06-2015 DEPAR'IMENT OF HEALTH AND HUMAN SERVICES

Public Health Service

February 27, 2006

Food and Drug Administration Center for Devices and Radiological Health Office of Device Evaluation Document Mail Center (HFZ-401) 9200 Corporate Blvd. Rockville, Maryland 20850

DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DR. P.O. BOX 988 WARSAW, IN 46581 ATTN: STEVEN J. WENTWORTH

510(k) Number: K060515 Received: 27-FEB-2006 Product: DEPUY PFC SIGMA KNEE PROSTHESIS

The Food and Drug Administration (FDA), Center for Devices and Radiological Health ':CDRH). has received the Premarket Notification you submitted in accordance >~ith Section 510(k) of the Federal Food, Drug, and Cosmetic Act(Act) for the above referenced product. We have assigned your submission a unique 510(k) number that is cited above. Please refer prominently to this SlO(k) number in any futuLe correspondence that relates to this submission. We will notify you when the processing of your premarket notification has been completed or if any additional information is required. YOU MAY NOT PLACE THIS DEVICE INTO COMMERCIAL DISTRIBUTION UNTIL YOU RECEIVE A LETTER FROM FDA ALLOWING YOU TO DO SO. On May 21, 2004, FDA issued a Guidance for Industry and FDA Staff entitled, "FDA and Industry Actions on Premarket Notification (510(k)) Submissions: Effect on FDA Review Clock and Performance Assessment 11 • The purpose of this document is to assist agency staff and the device industry in understanding how various FDA and industry actions that may be taken on 510(k)s should affect the review clock for purposes of meeting the Medical Device User Fee and Modernization Act. Please review this document at http://www.fda.gov/cdrh/mdufma/guidance/1219.html. On August 12, 2005 CDRH issued the Guidance for Industry and FDA Staff: Format for Traditional and Abbreviated 510(k)s. This guidance can be found at http://www.fda.gov/cdrh/ode/guidance/1567.html. Please refer to this guidance for assistance on how to format an original submission for a Traditional or Abbreviated 510(k). Please remember that all correspondence concerning your submission MUST be sent to the Document Mail Center (DMC) (HFZ·401) at the above letterhead address. Correspondence sent to any address other than the one above will not be considered as part of your official premarket notification submission. Also, please note the new Blue 3ook Memorandum regarding Fax and E·mail Policy entitled, 11 Fax and E-Mail Communication with Industry about Premarket Files Under Review 11 • Please refer to this guidance for information on current fax and e-mail practices at www.fda.gov/cdrh/ode/a02·01.html. You should be familiar with the regulatory requirements for medical device available at Device Advice http://www.fda.gov/cdrh/devadvice/". I f you have other procedural or policy questions, or want information on how to check on the status of your submission, please contact DSMICA at (3011 443·6597 or its toll-free number (BOO;, 638-2041, or at their Internet address http://www.fda.gov/cdrh/dsmamain.html or me at (301)594·1190. Sincerely yours,

Marjorie Shulman Supervisory Consumer Safety Officer Office of Device Evaluation

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

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Records processed under FOIA Request # 2015-2557; Released by CDRH on 10-06-2015

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DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION MEDICAL DEVICE USER FEE COVER SHEET

PAYMENT IDENTIFICATION NUMBER: (b) (4) Write the Payment Identification number on your check.

'1pleted Cover Sheet must accompany each original application or supplement subject to fees. The following actions must be taken )erly submit your application and fee payment: _tedronically submits the completed Cover Sheet to the Food and Drug Administration (FDA) before payment is sent. 2. Include printed copy of this completed Cover Sheet with a check made payable to the Food and Drug Administration. Remember that the Payment Identification Number must be written on the check. 3. Mail Check and Cover Sheet to the US Bank Lock Box, FDA Account, P.O. Box 956733, St. Louis, MO 63195-6733. (Note: In no case should payment be submitted with the application.) 4. If you prefer to send a check by a courier, the courier may deliver the check and Cover Sheet to: US Bank, Attn: Government Lockbox 956733, 1005 Convention Plaza, St. Louis, MO 63101. (Note: This address is for courier delivery only. Contact the US Bank at314418-4821 if you have any quesftons concerning courier delivery.) 5

For Wire Transfer Payment Procedures, please refer to the MDUFMA Fee Payment Instructions at the following URL: http://www.fda.gov/cdrh/mdufma/faqs.htm1#3a. You are responsible for paying all fees associated with wire transfer.

6. Include a copy of the complete Cover Sheet in volume one of the application when submitting to the FDA at either the CBER or CDRH Document Mail Center. -->

2. CONTACT NAME

1. COMPANY NAME AND ADDRESS (include name, street address, city state, country, and post office code)

Andee Tilden 2.1 E-MAIL ADDRESS [email protected]

DEPUY ORTHOPAEDICS INC 700 ORTHOPAEDIC DRIVE WARSAW IN 46580

2.2 TELEPHONE NUMBER (include Area code)

us

,j C~ c~~~-445

(FAX) NUMBER (Include Area code)

1.1 EMPLOYER IDENTIFICATION NUMBER (EIN)

574-37

987

352109957 3. TYPE OF PRE MARKET APPLICATION (Select one of the following in each column: if you are unsure, please refer to the application descriptions at the following web site: http://www.fda.gov/dc/mdufma S..eJe.9! an applicatiQ!1_j~: ~market notification(510(k)); except for third party

3.,__1_ SelecLQn§__Qf_lb_§_tyQ_es below {X] Original Application

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I] Modular PMA 1] Product Development Protocol I] Pre market Report (PMR)

SJ,!Qplementiwes: I] Efficacy (BLA)

I] Panel Track (PMA,

PMR, PDP)

I] Real-Time (PMA, PMR, PDP)

(PDP)

I ]180-day (PMA,

PMR, PDP)

4. ARE YOU A SMALL BUSINESS? {See the instructions for more information on determining this status) []YES, I meet the small business criteria and have submitted the required qualifying documents to FDA 4.1 If Yes, please enter your Small Business Decision Number:

[X] NO, I am not a small business

5. IS THIS PREMARKET APPLICATION COVERED BY ANY OF THE FOLLOWING USER FEE EXCEPTIONS? IF SO, CHECK THE APPLICABLE EXCEPTION. [] This application is the first PMA submitted by a qualified small business, [] The sole purpose of the application is to support including any affiliates, parents, and partner firms conditions of use for a pediatric population .

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[] The application is submitted by a state or federal

~!~~~ssb~~f;~c~c~~~~~~a~~ond~c~~~:~~=~ ~~~~~~:~~:~~~~:utr~~gPuus~~~nly ~~~e~~~c~~~~yentity for a device that is not to be distributed 6. IS THIS A SUPPLEMENT TO A PREMARKET APPLICATION FOR WHICH FEES WERE WAIVED DUE TO SOLE USE IN A PEDIATRIC POPULATION THAT NOW PROPOSES CONDITION OF USE FOR ANY ADULT POPULATION? (11 so, the applica1ion is subject to the fee that applies for an original premarket approval application (PMA).)

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IX] NO

YES

7. USER FEE PAYMENT AMOUNT SUBMITIED FOR THIS PREMARKET APPLICATION (FOR FISCAL YEAR 2005)

(b) (4) r

20-Jan-2006

·,Ill (OR/2003)

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1/20/200

Records processed under FOIA Request # 2015-2557; Released by CDRH on 10-06-2015 Invoice No. Date CR12679S8

Discount

Net Amount

FilA USERFEE/ATILDEN 3,833.00

3,833.00

Ycher Att Gross AMt

111505 N67958 Y

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COpy VISIT OUR WEBSITE· AT WWW.AF'.JNJ.COM FOR INVOICING ON THEWEB, ELECTRONIC•PAYMENJ"$, AND PAYMENT HISTORY, YOUR SUPPLIER NUMBER IS 080485527 Query? Ca.ll 877-551~4487 or wrih DEPUY ORTHOPAEDICS SUPPLIER#: 080485527 SUPPLIER: FOOD AND DRUG ADHINIS Please Y~li~ate Tax Id # ==> ElN 00-0000000

·sox 16524, NEW BRUNSWICK NJ 08906 TOTAL: 3,833.00

(b)(4)

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Records processed under FOIA Request # 2015-2557; Released by CDRH on 10-06-2015

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Records processed under FOIA Request # 2015-2557; Released by CDRH on 10-06-2015

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(b) (4)

Records processed under FOIA Request # 2015-2557; Released by CDRH on 10-06-2015

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Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

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processed under FOIA Request # 2015-2557; Released by CDRH on 10

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Symbollen selit)o\ " L-.eu 1f ""1"'"1-11 WARNINGS AND PRECAUTIONS CAUTION: Implants and tnat DOmponent• from dtfferent manufaoluroro or unplant syo [)., ~nl .JIInw porouo surfaces to come"' contact w1111 cloth or other fiiJer •eleasmg matenals Pnor ''' '"rVISUal 1nspect1on of each IMplant compo~ant lor possible Imperfections •l1o~ld performed oamage or alterations to any •mptant com~onent may prnduce >lresOe thoroughly ch~ckeo111zad t)o'lor to imptantll\lon according to the lollowtng lntllnrc;Uons. Ultra H9h Molecular Weoght Polyethyier>e (UHMWPE) liblsl ar>d patell,.. components are ir>di.,dually packaged and supplied STERILE Remove from the package using accepted sterile techniqoe only after me correct size ha• been dotermlned Poiyatl1ylotne com~ IOI>ould not boo ,.. ttterililed. F.,- potye11rylane components: DO NOT USE IF THE snAILE PACKAGE APPEARS TO BE DAMAGED. RINSINQ/CI..EANINO Use steriiB room temperature water or phystoiogtc:al saltne to soak tl"oa •mplant Soak me Implant tor a mommum ol5 minutes. Immediately dry the product Inspect the1mp1ant pnor to stenltUUion STERILIZATION (matrol componronta ~ II steniOtatlon IS necessary, the lollowtng paramelers are recommended as lhrty na"e been "altdatr>d for a Stenl!ly Assurance Level (SAL) of 1o-o;

ontact FDA/CDRH/OCE/DID at [email protected] or 3

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