K Number

Device Name

DEPUY KNEE PROSTHESIS SYSTEM UNIVERSAL STEM EXTENSIONS AND FEMORAL METAPHYSEAL SLEEVES

Manufacturer

DEPUY ORTHOPAEDICS, INC.

Date Cleared

2007-03-02

(86 days)

Product Code

JWH

Regulation Number

888.3560

Intended Use

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. 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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K040281, K941769

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes mechanical components for knee replacement surgery and does not mention any software, algorithms, or AI/ML capabilities.

Therapeutic

Yes
The device, comprising a femoral metaphyseal sleeve and a femoral stem, is used with knee prostheses in total knee replacement surgery to alleviate severe pain and disability caused by conditions such as arthritis, trauma, or failed prior surgical interventions, thus providing therapeutic benefit.

Diagnostic

The device description indicates that the DePuy Universal Femoral Metaphyseal Sleeve and Universal Stem components are implants used in total knee replacement surgery, not devices used for diagnosis. While the "Intended Use" section lists "Specific diagnostic indications for use" like "Malignant tumors," these are conditions that the device addresses therapeutically by replacing damaged or resected bone, not conditions that the device diagnoses.

SaMD (Software as a Medical Device)

The device description clearly details physical components made of Ti6-A14-V alloy and commercially pure titanium, intended for surgical implantation. There is no mention of software as the primary or sole component.

IVD (In Vitro Diagnostic)

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
Device Description and Intended Use: The description clearly states that the DePuy Universal Femoral Metaphyseal Sleeve and Universal Stem components are implants used in total knee replacement surgery. They are physical components designed to replace damaged bone and joint structures.
Lack of Diagnostic Activity: There is no mention of this device being used to analyze biological samples or provide diagnostic information about a patient's condition. Its function is purely mechanical and structural within the body.

Therefore, this device falls under the category of a surgical implant or prosthesis, not an In Vitro Diagnostic.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes (comma separated list FDA assigned to the subject device)

87 JWH

Device Description

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 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

femur, tibia, knee

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K040281, K941769

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

14063633

MAR 0 2 2007

SUMMARY OF SAFETY AND EFFECTIVENESS

| NAME OF FIRM: | DePuy Orthopaedics Inc.
700 Orthopaedic Drive
Warsaw, Indiana 46581-0988
EST REG No.: 1818910 |
|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(K) CONTACT: | Steve Wentworth
Regulatory Affairs Project Manager
Tel: (574) 371-4913
Fax: (574) 371-4987 |
| TRADE NAME: | DePuy Knee Prosthesis System Universal Stem Extensions and
Universal 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 |
| SUBSTANTIALLY
EQUIVALENT DEVICES: | Universal Femoral Metaphyseal Sleeve Components: DePuy LPS
Knee System (K040281, cleared July 9, 2004)
Universal Stem Extensions: S-ROM/Noiles™ PS Total Knee System
(K941769, cleared February 1, 1995) |

DEVICE DESCRIPTIONS:

0000004

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.

0000005 Regulatory_affairs/510(k)/2006/stmslvprmkt.doc

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.

00000006

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

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

Indications for Use Statement

510(k) Number (if known): _