noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis of . the natural femoral head;
rheumatoid arthritis; .
correction of functional deformity; .
femoral fracture; .
This device may also be indicated in the salvage of previously failed surgical attempts.

Device Description

The modification consists of a change to the Instructions for Use to minimize the necessity for multiple IFU's and to update the contents to reflect current practice.

AI/ML Overview

This document, K070221, is a 510(k) premarket notification for three hip joint devices: FMP™ Metal/Metal Acetabular Insert, Metal/Metal Hip System, and CLP® Offset Total Hip System. The core of this submission is a change to the Instructions for Use (IFU) to simplify the number of IFUs and update content to current practice.

Crucially, this submission is NOT for a new device requiring performance studies or acceptance criteria related to efficacy or safety in the way an AI/ML device would. It's a regulatory change based on the existing predicate devices. Therefore, the questions regarding acceptance criteria, device performance, sample sizes, expert ground truth, MRMC studies, or standalone algorithm performance are not applicable to this type of submission.

The FDA's review as detailed in the letter (pages 3-4) is based on substantial equivalence to legally marketed predicate devices, meaning the FDA has determined that the modified device is as safe and effective as a previously cleared device. There is no new clinical data or performance study required for this type of IFU change.

However, to directly address the prompt's requirements, I will explain why each point is not applicable based on the provided document:

1. A table of acceptance criteria and the reported device performance

Not Applicable. This submission is for a change to the Instructions for Use (IFU) of an already marketed device, not for a new device requiring specific performance acceptance criteria for clinical efficacy or safety beyond what was established for its predicate devices. The "performance" mentioned in the document refers to the general functional performance of the hip joint prostheses, which has already been established and is not being re-evaluated through new clinical trials as part of this submission. The change is purely regulatory and administrative.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Applicable. No new test set data was used or required for this IFU modification. The safety and effectiveness are established through substantial equivalence to predicate devices, which implies that their original clinical data (if any was required for those predicates) supports the device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable. No new ground truth establishment was needed. The submission is a regulatory update to existing device documentation, not a clinical study involving diagnosis or interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. No test set was used, therefore no adjudication method was employed.

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 hip implant device, not an AI/ML diagnostic or assistive device. MRMC studies are irrelevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable. This is a hip implant device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not Applicable. No new ground truth was established for this submission. The basis for marketing approval is substantial equivalence to legally marketed predicate devices, meaning the safety and effectiveness are considered comparable based on previously accepted data and scientific principles for those predicates.

8. The sample size for the training set

Not Applicable. This is a hip implant device, not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established

Not Applicable. As above, this is not an AI/ML device, and no training set or associated ground truth establishment was part of this submission.

Summary

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

Summary of Safety and Effectiveness

Date: January 23, 2007

Manufacturer: Encore Medical, L.P. 9800 Metric Blvd Austin, TX 78758

Contact Person: Teffany Hutto Regulatory Affairs Specialist Phone: (512) 834-6255 Fax: (512) 834-6313 Email: Teffany Hutto@encoremed.com Trade Name: FMP™ Metal/Metal Acetabular Insert

Common Name: Acetabular Insert

Classification Name: Hip joint metal/metal semi-constrained, with an uncemented component, prosthesis per 21 CFR 888.3330

Description: The modification consists of a change to the Instructions for Use to minimize the necessity for multiple IFU's and to update the contents to reflect current practice.

Intended Use: Joint replacement is indicated for patients suffering from disability due to:

noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis of . the natural femoral head;
. rheumatoid arthritis;
. correction of functional deformity:
femoral fracture; .

This device may also be indicated in the salvage of previously failed surgical attempts.

Comparable Features to Predicate Device(s): Features comparable to predicate devices include the same materials, design, indications, packaging, and sterilization.

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

Summary of Safety and Effectiveness

Date: January 23, 2007

Manufacturer: Encore Medical, L.P. 9800 Metric Blvd Austin, TX 78758

Contact Person: Teffany Hutto Regulatory Affairs Specialist Phone: (512) 834-6255 Fax: (512) 834-6313 Email: Teffany Hutto@encoremed.com Trade Name: Metal/Metal Hip System

Common Name: Total Hip Prosthesis, Semi-Constrained

Classification Name: Hip joint metal/metal semi-constrained, with an uncemented component, prosthesis per 21 CFR 888.3330

The modification consists of a change to the Instructions for Use to minimize the Description: necessity for multiple IFU's and to update the contents to reflect current practice.

Intended Use: Joint replacement is indicated for patients suffering from disability due to:

noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis of . the natural femoral head;
rheumatoid arthritis; .
correction of functional deformity; .
. femoral fracture;

This device may also be indicated in the salvage of previously failed surgical attempts.

Comparable Features to Predicate Device(s): Features comparable to predicate devices include the same materials, design, indications, packaging, and sterilization.

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

Summary of Safety and Effectiveness

Date: January 23, 2007

Manufacturer: Encore Medical, L.P. 9800 Metric Blvd Austin, TX 78758

Contact Person: Teffany Hutto Regulatory Affairs Specialist Phone: (512) 834-6255 Fax: (512) 834-6313 Email: Teffany Hutto@encoremed.com Trade Name: CLP® Offset Total Hip System

Common Name: Total Hip Prosthesis, Semi-Constrained

Classification Name: Hip joint metal/metal semi-constrained, with an uncemented component, prosthesis per 21 CFR 888.3330

Description: The modification consists of a change to the Instructions for Use to minimize the necessity for multiple IFU's and to update the contents to reflect current practice.

Intended Use: Joint replacement is indicated for patients suffering from disability due to:

. noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis of the natural femoral head;
. rheumatoid arthritis;
. correction of functional deformity;
femoral fracture; ●

This device may also be indicated in the salvage of previously failed surgical attempts.

Comparable Features to Predicate Device(s): Features comparable to predicate devices include the same materials, design, indications, packaging, and sterilization.

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/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 stripes forming its body and wing. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Public Health Service

APR 4 - 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Encore Medical, L.P. % Ms. Teffany Hutto Regulatory Affairs Specialist 9800 Metric Boulevard Austin, Texas 78758

Re: K070221

Trade/Device Name: FMP™ Metal/Metal Acetabular Insert; Metal/Metal Hip System; CLP® Offset Total Hip System Regulation Number: 21 CFR 888.3330 Regulation Name: Hip joint metal/metal semi-constrained, with uncemented acetabular component, prosthesis Regulatory Class: Class III Product Codes: KWA, JDI, KWL, KWY, KWZ, LPH, LWJ, LZO Dated: January 23, 2007 Received: January 24, 2007

Dear Ms. Hutto:

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 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.

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

Page 2 - Ms. Teffany Hutto

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 vours.

Валере Внекитр

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

Enclosure

{5}------------------------------------------------

510(k) Number (if known): ___________________________________________________________________________________________________________________________________________________

Device Name: FMP™ Metal/Metal Acetabular Insert

Indications for Use:

FMPTM Metal/Metal Acetabular Insert Indications for Use

Joint replacement is indicated for patients suffering from disability due to:

noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis of . the natural femoral head;
rheumatoid arthritis; .
correction of functional deformity; .
femoral fracture; .

This device may also be indicated in the salvage of previously failed surgical attempts.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Barbara Neelup

ision Sign-9 Division of General, Restorative, and Neurological Devices

510(k) Number K070221

Page 1 of 1

{6}------------------------------------------------

510(k) Number (if known):

Device Name: Metal/Metal Hip System

Indications for Use:

Metal/Metal Hip System Indications for Use

Joint replacement is indicated for patients suffering from disability due to:

· noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis of the natural femoral head;
rheumatoid arthritis; .
correction of functional deformity; .
femoral fracture; .

This device may also be indicated in the salvage of previously failed surgical attempts.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C) -

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

{7}------------------------------------------------

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: CLP® Offset Total Hip System

Indications for Use:

CLP® Offset Total Hip System Indications for Use

Joint replacement is indicated for patients suffering from disability due to:

noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis of . the natural femoral head;
rheumatoid arthritis; .
correction of functional deformity; .
femoral fracture; .

This device may also be indicated in the salvage of previously failed surgical attempts.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Regulation Number and Section

§ 888.3330 Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis.

(a)
Identification. A hip joint metal/metal semi-constrained, with an uncemented 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. The femoral component is intended to be fixed with bone cement. The acetabular component is intended for use without 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 an uncemented 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 an uncemented acetabular component that was in commercial distribution before May 28, 1976. Any other hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.