Severely painful and/or disabled joint as a result of arthritis, traumatic . arthritis, rheumatoid polyarthritis, or congenital hip dysplasia
Avascular necrosis of the femoral head .
Acute traumatic fracture of the femoral head or neck .
Failure of previous hip surgery, joint reconstruction, internal fixation, . arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.

Device Description

The device modifications to the Medacta Total Hip Prosthesis System which are the subject of this special 510(k) are as follows:

Line Extension to include CoCrMo Femoral ball heads of 22 mm diameter: These CoCrMo femoral ball heads would be used with Quadra® S femoral stems from the Medacta Total Hip Prosthesis System (K072857) and the Ortho Development's Triplus® Acetabular cups and liners.

Line Extension to include CoCrMo Femoral ball heads of 36 mm diameter: These CoCrMo femoral ball heads would be used with Quadra® S femoral stems from the Medacta Total Hip Prosthesis System and the Ortho Development's Triplus® Acetabular cups and liners.

Labeling to allow the use of Medacta Quadra® S stems from Medacta Total Hip Prosthesis system and Medacta CoCrMo Femoral ball heads of sizes 22 and 28 mm with Ortho Development's Pivot Bipolar heads. The Ortho Development's Pivot Bipolar heads were previously cleared under K050966.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device modification, specifically a "Line Extension" to the Medacta Total Hip Prosthesis System. The core purpose of this type of submission is to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through extensive new performance studies. Therefore, the information requested in your prompt regarding acceptance criteria and a study proving their fulfillment is largely not applicable in the context of this specific document.

Here's why and what information can be extracted:

Type of Submission: This is a Special 510(k) for a "Line Extension," which means the manufacturer is a modifying an already cleared device (K072857) with minor changes (new femoral ball head diameters and allowing use with previously cleared bipolar heads). The modifications are considered to not raise new questions of safety and effectiveness.
Focus on Substantial Equivalence: The primary "acceptance criterion" for a 510(k) is demonstrating "substantial equivalence" to a predicate device. This is achieved by showing that the new device has the same intended use and technological characteristics as the predicate, or that any differences do not raise new questions of safety or effectiveness.
"Performance Testing" Section: The document explicitly states: "No performance standards applicable to this device have been adopted under Section 514 of the Food, Drug and Cosmetic Act." It also notes, "Risk analysis was conducted on the impact of these changes and appropriate design verification and validation was conducted under the company's design controls." This implies that the 'study' to prove acceptance criteria was primarily focused on internal design controls and risk analysis related to the specific modifications, rather than a large-scale clinical or comparative performance study.

Given the nature of this document, I cannot fill out the table and detailed sections as you might expect for a de novo submission or a PMA where new performance data is central. However, I can explain why these sections are not present and provide what little relevant information exists.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (e.g., Sensitivity, Specificity, Accuracy > X%)	Reported Device Performance
Not applicable. The primary "acceptance criterion" for a 510(k) is demonstrating Substantial Equivalence to a predicate device (K072857). This is a regulatory threshold, not a specific performance metric like sensitivity or accuracy.	The device (Medacta Total Hip Prosthesis System - Line Extension) was determined to be substantially equivalent to its predicate device (Medacta Total Hip Prosthesis System, K072857) with respect to indications for use and technological characteristics.

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 for external large-scale test sets. The document describes modifications to an existing device. The "performance testing" mentioned refers to internal design verification and validation activities conducted under the company's design controls and risk analysis. These would typically involve testing of materials, components, and assemblies against design specifications, rather than a "test set" of patients or images as might be seen for diagnostic AI. The document does not provide details on sample sizes or data provenance for these internal tests.

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. There is no mention of a "test set" requiring expert ground truth in the context of this 510(k) submission. The evaluation is mechanical and regulatory, focused on the safety and performance changes of the physical device components.

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

Not applicable. As there is no external "test set" or diagnostic performance evaluation, adjudication methods are not relevant.

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 document is for a hip prosthesis system, not an AI-powered diagnostic device. Therefore, MRMC studies and 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 document is for a hip prosthesis system, not an algorithm or AI device.

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

Not applicable. For this type of device modification, "ground truth" would be established through engineering specifications, material testing standards, and risk analyses (e.g., ensuring new components meet strength requirements, wear characteristics, biocompatibility standards, etc.). These are typically internal verification and validation activities.

8. The sample size for the training set

Not applicable. As this is for a physical medical device, there is no "training set" in the context of machine learning or AI.

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

Not applicable. As there is no "training set," this question is not relevant.

In summary, this 510(k) pertains to a physical medical device (hip prosthesis system) undergoing a minor modification. The "study" mentioned for acceptance is primarily focused on internal design controls, risk analysis, and demonstrating "substantial equivalence" to a predicate device, as opposed to generating new clinical or performance data against specific acceptance criteria for a new feature or algorithm.

Summary

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K0B0885 (pg 1/2)

Image /page/0/Picture/1 description: The image shows the logo for Medacta International. The logo consists of a black triangle on the left, followed by the word "Medacta" in black letters. Below the word "Medacta" is the word "International" in a smaller font size. To the right of the word "International" is a small symbol that appears to be a plus sign inside a square.

Special 510(k) Summary

APR 2 8 2008

MEDACTA International SA Manufacturer: Strada Regina CH6874 Castel San Pietro Switzerland Phone (+41) 91 696 60 60 (+41) 91 696 60 66 FAX

Ms. Natalie J. Kennel Contact Person: Consultant NJK & Associates, Inc. 13721 Via Tres Vista San Diego, CA 92129 USA Phone: (858) 705-0350 Fax: (858) 764-9739 email: NKennel@njkconsulting.com

March 28, 2008 Date Prepared:

DEVICE INFORMATION

Trade/Proprietary Name: Medacta Total Hip Prosthesis System - Line Extension Hip Joint, metal/polymer/metal semi-Common/Classification Name: constrained cemented prosthesis

21 CFR 888.3350 Class II Device Product Code: JDI

Predicate Devices:

The Medacta Total Hip Prosthesis - Line Extensions are substantially equivalent to the Medacta Total Hip Prosthesis System cleared under K072857 on Feb. 4, 2008.

Product Modification:

The device modifications to the Medacta Total Hip Prosthesis System which are the subject of this special 510(k) are as follows:

Special 510(k) - Line Extension 510(k) March 28, 2008

Company Confidential Page 19 of 115

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Indications for Use:

The Medacta Total Hip Prosthesis System is intended for cementless use in total or partial hip arthroplasty and in primary or revision surgery.

Hip replacement is indicated in the following cases:

Severely painful and/or disabled joint as a result of arthritis, traumatic . arthritis, rheumatoid polyarthritis, or congenital hip dysplasia
Avascular necrosis of the femoral head .
Acute traumatic fracture of the femoral head or neck .
Failure of previous hip surgery, joint reconstruction, internal fixation, . arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.

The indications for use for the modified system remain the same as the original 510(k), K072857.

Performance Testing

No performance standards applicable to this device have been adopted under Section 514 of the Food, Drug and Cosmetic Act.

Risk analysis was conducted on the impact of these changes and appropriate design verification and validation was conducted under the company's design controls.

Conclusion:

The results from design controls and the information provided in this submission support the conclusion that the Medacta Total Hip Prosthesis System - Line Extensions are substantially equivalent to its predicate device, Medacta Total Hip Prosthesis System with respect to indications for use and technological characteristics.

Medacta Total Hip Special 510(k) - Line Extension March 28, 2008

Company Confidential Page 20 of 115

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with a double helix-like design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus. The seal is presented in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MEDACTA International, SA % NJK & Associates, Inc. Ms. Natalie J. Kennel Consultant 13721 Via Tres Vista San Diego, CA 92129

APR 2 8 2008

Re: K080885

Trade/Device Name: Medacta Total Hip Prosthesis System - Line Extension Regulation Number: 21 CFR 888.3350 Regulation Name: Hip joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: JDI Dated: March 28, 2008 Received: March 31, 2008

Dear Ms. Kennel:

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.

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Page 2 - Ms. Natalie J. Kennel

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark M. Millman

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): KO800885 (pcg // /

Device Name: Medacta Total Hip Prosthesis System - Line Extension

Indications for Use:

The Medacta Total Hip Prosthesis System is intended for cementless use in total or partial hip arthroplasty and in primary or revision surgery.

Hip replacement is indicated in the following cases:

Severely painful and/or disabled joint as a result of arthritis, traumatic . arthritis, rheumatoid polyarthritis, or congenital hip dysplasia
Avascular necrosis of the femoral head ●
Acute traumatic fracture of the femoral head or neck ●
Failure of previous hip surgery, joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.

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

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nel re ogl
(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

Page of

510(k) Number K080885

Regulation Number and Section

§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. A hip joint metal/polymer semi-constrained cemented prosthesis is a 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 have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.