The PROFEMUR® Tapered 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® Tapered Hip Stem are summarized below:

Modular neck taper
Tapered cylindrical distal stem
Plasma Sprayed proximal body
Grit blasted distal stem
Polished bullet tip
Spines

AI/ML Overview

This document is a 510(k) summary for the PROFEMUR® Tapered Hip Stem. It asserts substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a study. Therefore, most of the requested information regarding acceptance criteria, study design, and performance metrics is not available in this type of document.

Here's an analysis based on the provided text, highlighting what is and isn't present:

1. Table of Acceptance Criteria and Reported Device Performance:

Not applicable. This 510(k) summary does not present specific quantitative acceptance criteria or a study demonstrating direct device performance against those criteria. Instead, it argues for substantial equivalence to existing predicate devices.

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

Not applicable. No new study involving a test set is described. The submission relies on "substantial equivalence information, materials information, and analysis data" (page 1) in comparison to predicate devices. The data provenance and sample sizes for this "analysis data" are not specified.

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

Not applicable. There is no described test set requiring ground truth establishment by experts.

4. Adjudication Method for the Test Set:

Not applicable. No test set or adjudication method is described.

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

Not applicable. This device is a hip stem (a medical implant), not an AI-assisted diagnostic or therapeutic tool. Therefore, MRMC studies involving human readers or AI assistance are irrelevant to this submission.

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

Not applicable. This device is a physical implant, not an algorithm.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.):

Not applicable. No new ground truth for performance evaluation is established or described explicitly. The basis for safety and effectiveness is "substantial equivalence" to predicate devices, implying that the established safety and effectiveness of the predicates serve as the basis for comparison.

8. The Sample Size for the Training Set:

Not applicable. This is not an AI/algorithm-based device requiring a training set.

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

Not applicable. This is not an AI/algorithm-based device.

Summary of what is available from the document:

The document, a 510(k) Summary of Safety and Effectiveness, focuses on establishing substantial equivalence of the PROFEMUR® Tapered Hip Stem to legally marketed predicate devices.

Basis for Equivalence: The submission states, "The safety and effectiveness of the PROFEMUR® Tapered Hip Stem are adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification" (page 1).
Predicate Devices: The device is deemed substantially equivalent to the PROFEMUR® Z Hip Stem, the PERFECTA® RS Hip Stem, and the PERFECTA® Plasma Sprayed Hip Stem. The indications for use and materials are stated to be identical to the PROFEMUR® Z Hip Stem.
Device Information: The document provides a description of the device's design features (e.g., modular neck taper, tapered cylindrical distal stem, plasma sprayed proximal body).
Intended Use/Indications for Use: These are clearly defined for total hip arthroplasty in skeletally mature patients with conditions such as non-inflammatory degenerative joint disease, inflammatory degenerative joint disease, correction of functional deformity, and revision procedures.

In essence, a 510(k) submission like this does not typically include a direct study proving device performance against acceptance criteria in the way an AI/software device would. Instead, it's a regulatory pathway to demonstrate that a new device is as safe and effective as a legally marketed predicate device.

Summary

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K04/1114

Image /page/0/Picture/1 description: The image shows the word "WRIGHT." in bold, black letters. Underneath the word is a design of three horizontal lines that are stacked on top of each other. In the upper right corner of the image, there is a handwritten note that says "p. 1/2".

MAY 2 8 2004

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® Tapered Hip Stem.

Submitted By:	Wright Medical Technology, Inc.
Date:	April 26, 2004
Contact Person:	Katie Logerot
	Regulatory Affairs Specialist II
Proprietary Name:	PROFEMUR® Tapered Hip Stem
Common Name:	Hip Stem
Classification Name and Reference:	Prosthesis, hip, semi-constrained, metal/polymer, uncemented - Class II
	21CFR 888.3350 Hip joint metal/polymer, semi-constrained, cemented prosthesis - Class II
	Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented – Class II
	21 CFR 888.3320 Hip joint metal/ metal semi-constrained, with a cemented acetabular component prosthesis - Class III
	21 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

headquarters

Wright Medical Technology, Inc. 5677 Airline Road Arlington, TN 38002 901.867.9971 phone	www.wmt.com
international subsidiaries

ariana 011.32.2.378.3905 Belgium 011-39-0250-678.227 Italy

905.826.1600 Canada 011.81.3.3536.0474 Japan 011.33.1.45.13.24.40 France 011.44.1463.721.404 UK

011.49.4161.745130 Germany

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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, er
revision procedures where other treatments or devices have failed 4.

B. DEVICE DESCRIPTION

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

Modular neck taper ●
Tapered cylindrical distal stem .
Plasma Sprayed proximal body .
Grit blasted distal stem .
Polished bullet tip ●
. Spines

C. SUBSTANTIAL EQUIVALENCE INFORMATION

The indications for use and materials of the PROFEMUR® Tapered Hip Stem are identical to the PROFEMUR® Z Hip Stem. The design features of the PROFEMUR® Tapered Hip Stem are substantially equivalent to the PROFEMUR® Z Hip Stem, the PERFECTA® RS Hip Stem, and the PERFECTA® Plasma Sprayed Hip Stem. The safety and effectiveness of the PROFEMUR® Tapered 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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring three horizontal lines that curve upwards, resembling a stylized human figure or a symbol of growth and progress.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 8 2004

Ms. Katie Logerot Regulatory Affairs Specialist II Wright Medical Technology, Inc. 5677 Airline Road Arlington, Tennessee 38002

Re: K04114

Trade/Device Name: PROFEMUR® Tapered Hip Stem Trace/Device Name: 1 ROPERTOS: 200, 21 CFR 888.3330, 21 CFR 888.3350, and 21CFR 888.3353

Regulation Names: Hip joint metal/metal semi-constrained, with a cemented acetabular Fift fount mount besis, Hip joint 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: April 26, 2004 Received: April 28, 2004

Dear Ms. Logerot:

We have reviewed your Section 510(k) premarket notification of intent to market the device w o nave reviewed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for answers wior 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 (sec above) into cither 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 he 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

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Page 2 - Ms. Katie Logerot

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 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 (Scctions 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 (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 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,
Mark A. Milliken

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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K041114

Indications for Use

510(k) Number (if known):

Device Name: PROFEMUR® Tapered Hip Stem

Indications For Use:

1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
1. inflammatory degenerative joint disease such as rheumatoid arthritis;
1. correction of functional deformity; and,
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)

Mull Mullus Page 1 of 1

(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

510(k) Number

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.