The PROFEMUR® S Hip Stem is indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
inflammatory degenerative joint disease such as rheumatoid arthritis;
correction of functional deformity; and,
revision procedures where other treatments or devices have failed

Device Description

The design features of the PROFEMUR® S Hip Stem are summarized below:

Offered in two medial flare options .
Modular neck taper .
Triplanar proximal geometry w/ plasma spray .
Splined, slotted, and cylindrical distal stem w/ grit blast .
Dimple with cross slot on lateral shoulder ●
Polished distal tip and collar .

AI/ML Overview

The provided text does not contain any information regarding specific acceptance criteria or a study that evaluates the performance of the PROFEMUR® S Hip Stem against such criteria.

The document is a 510(k) Summary of Safety and Effectiveness for the PROFEMUR® S Hip Stem, which is focused on demonstrating substantial equivalence to predicate devices. This means the manufacturer is asserting that the new device is as safe and effective as a legally marketed device, rather than providing a performance study with specific acceptance criteria.

Therefore, I cannot provide the requested information. The document focuses on:

Intended Use: What the device is designed for.
Device Description: Its features.
Substantial Equivalence Information: Comparing it to existing devices to show it's fundamentally similar in design, materials, and technology.

There is no mention of a performance study, acceptance criteria, sample sizes, expert review, adjudication methods, MRMC studies, standalone performance, or how ground truth was established for any test or training sets.

Summary

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K041586 (pg 1 of 2)

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CRF 807, this information serves as a Summary of Safety and Effectiveness for the use of the PROFEMUR® S Hip Stem.

Submitted By:	Wright Medical Technology, Inc.
Date:	July 6, 2004
Contact Person:	Jeanine H. ReddenRegulatory Affairs Specialist II
Proprietary Name:	PROFEMUR® S Hip Stem
Common Name:	Hip Stem
Classification Name and Reference:	Prosthesis, hip, semi-constrained, metal/polymer, uncemented - Class II21CFR 888.3350 Hip joint metal/polymer, semi- constrained, cemented prosthesis - Class IIProsthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented - Class II21 CFR 888.3320 Hip joint metal/ metal semi- constrained, with a cemented acetabular component prosthesis - Class III21 CFR 888.3330 Hip joint metal/ metal semi- constrained, with an uncemented acetabular component prosthesis - Class III
Device Product Code and Panel Code:	Orthopedics/87/ LWJ, JDI, LZO, JDL, KWA

DEVICE INFORMATION

A. INTENDED USE

The PROFEMUR® S Hip Stem is indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

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non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, 1. ankylosis, protrusio acetabuli, and painful hip dysplasia;
inflammatory degenerative joint disease such as rheumatoid arthritis; 2.
correction of functional deformity; and, 3.
revision procedures where other treatments or devices have failed 4.

B. DEVICE DESCRIPTION

The design features of the PROFEMUR® S Hip Stem are summarized below:

Offered in two medial flare options .
Modular neck taper .
Triplanar proximal geometry w/ plasma spray .
Splined, slotted, and cylindrical distal stem w/ grit blast .
Dimple with cross slot on lateral shoulder ●
Polished distal tip and collar .

C. SUBSTANTIAL EQUIVALENCE INFORMATION

The indications for use and materials of the PROFEMUR® S Hip Stem are identical to the PERFECTA® RS and PROFEMUR® R Hip Stems. The design features of the PROFEMUR® S Hip Stem are substantially equivalent to the PERFECTA® RS, PROFEMUR® R, and PROFEMUR® Tapered Hip Stems. The fundamental scientific technology of the modified device has not changed relative to the predicate devices. The safety and effectiveness of the PROFEMUR® S Hip Stem are adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure with outstretched arms.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 0 9 2004

Ms. Jeanine H. Redden Regulatory Affairs Specialist II Wright Medical Technology, Inc. 5677 Airline Road Arlington, Tennessee 38002

Re: K041586

Trade/Device Name: PROFEMUR® S Hip Stem Trace Dovice Namer 21 CFR 888.3320, 21 CFR 888.3330, and 21 CFR 888.3350 Regulation Names: Hip joint metal/metal semi-constrained, with a cemented acetabular Frip Joint metal metal metal/metal semi-constrained, with an uncemented acetabular component, prosthesis; Hip joint metal/polymer semi-constrained cemented prosthesis; Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis; and Prosthesis, hip, semi-constrained, metal/polymer, uncemented

Regulatory Class: III Product Codes: JDL, KWA, JDI, LZO and LWJ Dated: June 9, 2004 Received: June 14, 2004

Dear Ms. Redden:

We have reviewed your Section 510(k) premarket notification of intent to market the device we never 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 for use stated in the encreations of the enactment date of the Medical Device Amendments, or to conimer of the to rialy 2011-11-11 in accordance with the provisions of the Federal Food, Drug, de noes that have been 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 If your de rice to such additional controls. Existing major regulations affecting your device can may or babyer to back frederal 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 r 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

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Page 2 – Ms. Jeanine H. Redden

comply with all the Act's requirements, including, but not limited to: registration and listing (21 Comply with an the 11th 3 requirements, 01); good manufacturing practice requirements as set CFK Fat 807), mocing (21 CFR Part 820); good was and if applicable, the electronic forth in the quality byticins (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) This icter will anow yourse over finding of substantial equivalence of your device to a legally premarket noticated.or. The PDF mising of cation 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 If you desire specific acrepliance at (301) 594-4659. 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 other general informational 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,

Lila Witt

Celia M. Witten, Ph.D., M.D. 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

510(k) Number (if known):

Device Name: PROFEMUR® S Hip Stem

Indications For Use:

The PROFEMUR® S Hip Stem is indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
inflammatory degenerative joint disease such as rheumatoid arthritis; 2.
correction of functional deformity; and, 3.
1. revision procedures where other treatments or devices have failed

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

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Division of General, Restorative, and Neurological Devices

Page 1 of 1

510(k) Number_K041586

Regulation Number and Section

§ 888.3320 Hip joint metal/metal semi-constrained, with a cemented acetabular component, prosthesis.

(a)
Identification. A hip joint metal/metal semi-constrained, with a cemented acetabular component, prosthesis is a two-part device intended to be implanted to replace a hip 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 consist of a femoral and an acetabular component, both made of alloys, such as cobalt-chromium-molybdenum. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class III.(c)
Date PMA or notice of completion of PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before May 18, 2016, for any hip joint metal/metal semi-constrained prosthesis with a cemented acetabular component that was in commercial distribution before May 28, 1976, or that has, on or before May 18, 2016, been found to be substantially equivalent to a hip joint metal/metal semi-constrained prosthesis with a cemented acetabular component that was in commercial distribution before May 28, 1976. Any other hip joint metal/metal semi-constrained prosthesis with a cemented acetabular component shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.