The DePuy Universal Femoral Metaphyseal Sleeve and Universal Stem components are intended for use with the PFC, Sigma PFC, Sigma TC3 Revision Knee, or S-ROM knee prostheses 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. These devices are intended for cemented use only.

The DePuy Universal Femoral Metaphyseal Sleeve and Universal Stem components are also intended for use with the DePuy LPS prosthesis for replacement of the mid-shaft portion of the femur, proximal, distal and/or total femur, and proximal tibia, especially in cases that require extensive resection and replacement. Specific diagnostic indications for use include: Malignant tumors (e.g., osteosarcomas, chondrosarcomas, giant cell tumors, bone tumors) requiring extensive resection and replacement; patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g. avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis, requiring extensive resection and replacement; revision for failed previous prosthesis cases requiring extensive resection and replacement; severe trauma requiring extensive resection and replacement. The LPS prosthesis is also intended for use in bone loss postinfection, where the surgeon has elected to excise the bone and replacement is required.

The Universal Stem and the Universal Metaphyseal Sleeve components are intended for cemented use only.

Device Description

DePuy is offering the DePuy Universal Femoral Metaphyseal Sleeve and the DePuy Universal Stem Extenstion components as line extensions to its previously cleared PFC, PFC Sigma, S-ROM, Sigma TC3 Revision Knee and Limb Preservation System (LPS) knee replacement prostheses systems. These additional components are designed to be interchangeable within these four knee systems.

The DePuy Universal Femeral Metaphyseal Sleeve components are a modification to the design of the previously cleared DePuy LPS Metaphyseal Sleeve included in K040281. The Universal Femoral Metaphyseal Sleeve components are available in five sizes. They are also available in nonporous textured finish, fully porous coated and distally porous coated options. The femoral metaphyseal sleeve components are optional components that attach to the femoral knee prostheses components by a taper locking mechanism. Use of adapter components are required for the attachment of the metaphyseal sleeve component to the PFC Sigma, LPS and Sigma TC3 femoral components. The metaphyseal sleeve attaches directly to the S-ROM femoral component. The threaded distal female portion of the femoral metaphyseal sleeve component receives the male threaded portion of the Universal Stem Extension to provide a stemmed femoral knee prosthesis construct. An optional polyethylene plug component is assembled to the metaphyseal sleeve.

The Universal Stem Extension component is an optional component available in three lengths and eight diameters. The distal portion of the stem extension below the male threaded portion is fluted and terminates in a bullet shaped tip. The stem extension component is perpendicularly quadrifurcated to allow for flexibility of the stem component under physiologic loads. The two smallest component diameters are solid. The DePuy Universal Stem Extension components are a modification to the design of the stem extension components previously cleared in K941769. These components can be attached to the female threaded portion of the Universal Femoral Metaphyseal Sleeve or may be attached without the sleeve to the PFC Sigma and Sigma TC3 femoral components using the adapters. The sleeve component is required for the LPS and S-ROM femoral components. The same male threaded attachment is used to connect the stem extensions to the tibial tray components from the PFC, PFC Sigma and Sigma TC3 Revision knee prosthesis systems. The stem extension in not used for the S-ROM tibial trays.

AI/ML Overview

It appears the provided document is a 510(k) premarket notification for universal stem extensions and universal femoral metaphyseal sleeves for knee prosthesis systems. This document does not describe a study to prove the device meets acceptance criteria in the way typically expected for a diagnostic AI or software device. Instead, it demonstrates substantial equivalence to previously cleared predicate devices.

Therefore, many of the requested categories (like acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and training set details) are not applicable or cannot be extracted from this type of regulatory submission. The concept of "acceptance criteria" here relates more to the regulatory standard of substantial equivalence for medical devices rather than performance metrics for an AI algorithm.

However, I can provide information based on the premise of substantial equivalence as outlined in the document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Regulatory Standard)	Reported Device Performance (Basis for Equivalence)
Universal Femoral Metaphyseal Sleeve: Substantial equivalence to LPS Metaphyseal Sleeve (K040281) regarding: `- Intended Use- Materials used- Design (as a modification)`	`- Intended Use: Same as predicate device.- Materials Used: Same (Ti6-A14-V alloy for primary components, CP titanium for porous coating).- Design: Modification to previously cleared LPS Metaphyseal Sleeve, available in five sizes, nonporous, fully porous coated and distally porous coated options. Attaches via taper locking mechanism.`
Universal Stem Extension: Substantial equivalence to S-ROM/Noiles™ Knee slotted stem component (K941769) regarding: `- Intended Use- Materials used- Design (as a modification)`	`- Intended Use: Same as predicate device.- Materials Used: Same (Ti6-A14-V alloy).- Design: Modification to previously cleared stem extension, available in three lengths and eight diameters. Fluted distal portion, perpendicularly quadrifurcated for flexibility. Two smallest diameters are solid.`

2. Sample Size Used for the Test Set and Data Provenance

Not applicable. This is a 510(k) submission for mechanical devices based on substantial equivalence to existing devices, not a performance study using a "test set" of data in the context of AI or diagnostic algorithms. The demonstration of equivalence relies on design comparisons, material specifications, and intended use as described, rather than statistical performance against a dataset.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This is not a study requiring expert consensus or ground truth establishment in the context of diagnostic performance. The ground truth for device safety and effectiveness is established through regulatory standards for manufacturing, materials, and design, and comparison to legally marketed predicate devices.

4. Adjudication Method for the Test Set

Not applicable. There was no "test set" or adjudication process in the sense of reviewing diagnostic outcomes.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

Not applicable. This is a submission for knee prosthesis components, not an AI or diagnostic software device that would involve human readers or AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is for mechanical knee prosthesis components, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" in this context is the regulatory acceptance of the safety and effectiveness of the predicate devices (DePuy LPS Knee System K040281 and S-ROM/Noiles™ PS Total Knee System K941769). The new devices establish their "truth" by demonstrating substantial equivalence to these legally marketed and accepted predicate devices in terms of intended use, materials, and design.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" for mechanical device substantial equivalence.

9. How the Ground Truth for the Training Set Was Established

Not applicable. There is no "training set" for mechanical device substantial equivalence. The "ground truth" for the predicate devices' acceptance would have been established through their own respective 510(k) clearances or pre-amendment status, based on regulatory evaluation of their design, materials, manufacturing, and clinical performance data (if required for their clearance).

Summary regarding the 510(k) process:

This document demonstrates that the Universal Stem Extensions and Universal Femoral Metaphyseal Sleeves are "substantially equivalent" to predicate devices already on the market. This is the primary "acceptance criterion" for a 510(k) premarket notification. The study, in this case, is the comparison and detailed description of the new device's design, materials, and intended use against those of the predicate devices. This type of submission relies on the established safety and effectiveness of the predicate devices.

Summary

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14063633

MAR 0 2 2007

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 Project ManagerTel: (574) 371-4913Fax: (574) 371-4987
TRADE NAME:	DePuy Knee Prosthesis System Universal Stem Extensions andUniversal Femoral Metaphyseal Sleeves
COMMON NAME:	Tricompartmental Knee Prosthesis
CLASSIFICATION:	Knee joint patellofemorotibial, polymer/metal/polymer semi-constrained cemented prosthesis (21 CFR 888.3560), Class II Device
DEVICE PRODUCT CODE:	87 JWH
SUBSTANTIALLYEQUIVALENT DEVICES:	Universal Femoral Metaphyseal Sleeve Components: DePuy LPSKnee System (K040281, cleared July 9, 2004)Universal Stem Extensions: S-ROM/Noiles™ PS Total Knee System(K941769, cleared February 1, 1995)

DEVICE DESCRIPTIONS:

The DePuy Universal Femoral Metaphyseal Sleeve components are a modification to the design of the previously cleared DePuy LPS Metaphyseal Sleeve included in K040281. The Universal Femoral Metaphyseal Sleeve components are available in five sizes. They are also available in nonporous textured finish, fully porous coated and distally porous coated options. The femoral metaphyseal sleeve components are optional components that attach to the femoral knee prostheses components by a taper locking mechanism. Use of adapter components are required for the attachment of the metaphyseal sleeve component to the PFC Sigma, LPS and Sigma TC3 femoral components. The

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metaphyseal sleeve attaches directly to the S-ROM femoral component. The threaded distal female portion of the femoral metaphyseal sleeve component receives the male threaded portion of the Universal Stem Extension to provide a stemmed femoral knee prosthesis construct. An optional polyethylene plug component is assembled to the metaphyseal sleeve.

The Universal Stem and Universal Femoral Metaphyseal Sleeve are both manufactured from Ti6-A14-V alloy. The porous coating on the Universal Femoral Metaphyseal Sleeve is comprised of sintered microbeads of commercially pure (CP) titanium. The Universal Stem Extension component is substantially equivalent to the S-ROM Knee System slotted stem extension component cleared previously under K941769 and the Universal Femoral Metaphyseal Sleeve component is substantially equivalent to the LPS Metaphyseal Sleeve cleared under K040281.

INDICATIONS FOR USE:

The DePuy Universal Femoral Metaphyseal Sleeve and Universal Stem components are intended for use with the PFC, PFC Sigma, Sigma TC3 Revision Knee, or S-ROM knee prostheses 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. These devices are intended for cemented use only.

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extensive resection and replacement; revision for failed previous prosthesis cases requiring extensive resection and replacement; severe trauma requiring extensive resection and replacement. The LPS prosthesis is also intended for use in bone loss postinfection, where the surgeon has elected to excise the bone and replacement is required.

The Universal Stem and the Universal Metaphyseal Sleeve components are intended for cemented use only.

BASIS FOR SUBSTANTIAL EQUIVALENCE:

The design of the DePuy Universal Femoral Metaphyseal Sleeve is substantially equivalent to the LPS Metaphyseal Sleeve (K040281). Since the intended use and materials used for the subject and predicate device components are the same, the DePuy Universal Femoral Metaphyseal Sleeve is considered to be substantially equivalent to the predicate device.

The design of the DePuy Universal Stem Extension is substantially equivalent to the S-ROM/Noiles Knee slotted stem component. Since the materials and intended use for the subject device components are identical to those for the predicate device, the DePuy Universal Stem Extension is considered substantially equivalent to the predicate device.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine, with three intertwined snakes and a staff. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DePuy Orthopaedics, Inc. % Mr. Steven J. Wentworth Regulatory Affairs Project Manager 700 Orthopaedic Drive P.O. Box 988 Warsaw, Indiana 46581-0988

Re: K063633

Trade/Device Name: DePuy Knee Prosthesis System Universal Stem Extensions and Universal Femoral Metaphyseal Sleeves Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWH Dated: December 5, 2006 Received: December 6, 2006

MAR 0 2 2007

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 comply with all the Act's requirements, including, but not limited to: registration and listing (21

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Page 2 - Mr. Steven J. Wentworth

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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,
Mark A Milkersen

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

Enclosure

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Indications for Use Statement

510(k) Number (if known): _ < 063633

Device Name: DePuy Universal Metaphyseal Sleeve and Universal Stem Extension

Intended Use and Indications:

The Universal Stem and the Universal Metaphyseal Sleeve components are intended for cemented use only.

Mark A. Millican

Division of General, Restorative, and Neurological Devices

Prescription Use × (Part 21 CFR 801 Subpart D) AND/

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K063633

Concurrence of CDRH, Office of Device Evaluation (ODE)

Regulatory affairs/510(k)/2006/stmslvprmkt.doc

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.