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.

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 stem extensions. The Sigma Femoral Adapters are available in five and neveous degree valgus angle options and +2 mm, 0 mm, and -- 2 mm anterior/posterior offset options.

AI/ML Overview

This document describes a 510(k) premarket notification for a medical device called the "DePuy Sigma Knee Prosthesis Femoral Adapter." This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through a traditional clinical study with defined acceptance criteria and performance metrics.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, and specific performance metrics (like those for AI/standalone algorithms) is not applicable to this type of regulatory submission.

Here's why and what information is provided:

510(k) Premarket Notification: This regulatory pathway focuses on demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device. This means it has the same intended use and the same technological characteristics as the predicate, or, if it has different technological characteristics, that the new device does not raise different questions of safety and effectiveness.
Basis for Substantial Equivalence (as described in the document):
- Design Similarity: The design of the PFC Sigma Knee Prosthesis Femoral Adapter is stated to be "substantially equivalent" to two predicate devices: the LPS Metaphyseal Sleeve (K040281) and the Darwin Knee System (TC3) (K952830).
- Material Identity: The materials used for the subject device components are identical to those of the predicate devices.
- Attachment Mechanism: The attachment mechanism incorporates similar adapter, retaining ring, and bolt components.
- Offset Options: The available offset options (+2mm anterior, neutral, -2mm posterior) are the same as the predicate devices.
- Valgus Angle Options: While both the PFC Sigma and Darwin Knee systems offer 5 and 7-degree valgus angle components, the LPS system offers only a 5-degree component. This difference is deemed acceptable within the substantial equivalence framework.
- Mechanical Testing: The document mentions "results from the mechanical testing of the PFC Sigma Femoral Adapter" as a basis for substantial equivalence. However, no specific performance metrics or acceptance criteria for this testing are provided in the excerpt. It's implied that these tests demonstrated the new device performed equivalently or acceptably compared to the predicate, likely according to industry standards for mechanical properties of knee implants.

In summary, the provided document does not contain the information requested in points 1-9 because it is a 510(k) submission focused on substantial equivalence rather than a study designed to meet specific performance acceptance criteria for a novel device or AI algorithm.

Summary

{0}------------------------------------------------

K060515 Page 1 of 2

MAR 2 3 2006

SUMMARY OF SAFETY AND EFFECTIVENESS

NAME OF FIRM:	DePuy Orthopaedics Inc.700 Orthopaedic DriveWarsaw, Indiana 46581-0988EST REG No.: 1818910
510(K) CONTACT:	Steve WentworthRegulatory Affairs ManagerTel: (574) 371-4913Fax: (574) 371-4987
TRADE NAME:COMMON NAME:	DePuy PFC® Sigma Knee ProsthesisTricompartmental Knee Prosthesis
CLASSIFICATION:	Knee joint patellofemorotibial, polymer/metal/polymer semi-constrained cemented prosthesis (21 CFR 888.3560), Class II Device
DEVICE PRODUCT CODE:	JWH
SUBSTANTIALLYEQUIVALENT DEVICES:	DePuy LPS Metaphyseal Sleeve Component(K040281, cleared July 9, 2004)Darwin Knee System (TC3)(K952830, cleared January 18, 1996)

DEVICE DESCRIPTION:

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 nermanent 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.

00000000

{1}------------------------------------------------

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 S 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.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three human figures within its body, representing the department's focus on health and human well-being. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular pattern around the eagle symbol.

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. Iisting 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 I'DA'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

{3}------------------------------------------------

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 801); good manufacturing practice requirements as set 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 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(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 801), 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/dsma/dsmamain.html

Sincerely yours.

Hukut Lumur 09

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

Enclosure

{4}------------------------------------------------

Indications for Use Statement

510(k) Number (if known):

Device Name: DePuy Sigma Knce Femoral Adapter

Intended Use and Indications:

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)

(Division Sign-6 Division of General, Restorative and Neurological Devices

510(k) Number Kol060515

0000008

Regulation Number and Section

§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.