The Medacta Total Hip Prosthesis System – Quadra C Femoral Stems are intended for cemented 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. Size 0 implants should not be implanted in patients with a mass of 65 kg or greater.

Device Description

This modification to the original Medacta Total Hip Prosthesis System -Quadra C femoral stems is a line extension to include the AMIStem C femoral stems and Quadra C Short Neck (SN) femoral stems. AMIStem C femoral stems are based on the design of the Quadra C femoral stems in the original submission. The AMIStem C femoral stems differ from the Quadra C femoral stems by a decreased length of 15% and a reduced shoulder. The Quadra C short neck femoral stems are the same design femoral stems as the Quadra C femoral stems in the original submission but the length of the neck that is 5 mm shorter. Like the Quadra C femoral stems, the AMIStem C femoral stems and the Quadra C SN femoral stems are highly polished, collarless femoral components manufactured from forged stainless steel according to ISO 5832-9. The AMIStem C femoral stems and the Quadra C SN femoral stems are straight quadratic stems with a triple taper shape. The proximal portion of the stem has a standard 12/14 taper for mechanical attachment to cleared Medacta International metallic or ceramic femoral heads. Like the Quadra C femoral stems, two different caput-collum-diaphyseal angles (CCD) are available for the AMIStem C femoral stems and the Quadra C Short neck femoral stems: 135° for the standard offset and 127° for the lateralized offset. The Quadra C short neck femoral stems come in eight sizes with a standard offset and seven sizes with a lateral offset. The AMIStem C femoral stems come in eight sizes with a standard offset and seven sizes with a lateral offset. There are no short neck versions for the AMIStem C femoral stems. The AMIStem C femoral stems and the Quadra C short neck femoral stems provide additional femoral stem options to the surgeon for use with the Medacta Total Hip Prosthesis System.

AI/ML Overview

This document describes the Medacta Total Hip Prosthesis System - AMIStem C and Quadra C SN femoral stems. As a 510(k) summary, the focus is on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with detailed performance metrics against specific acceptance criteria.

The information provided does not include:

A specific table of acceptance criteria and reported device performance.
Details on sample sizes used for test sets, training sets, or data provenance.
Information on the number or qualifications of experts for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance.
The type of ground truth used or how it was established for training sets.

Instead, the document states that performance testing was conducted according to various standards and FDA guidance documents, with predefined acceptance criteria based on these standards. The conclusion is that all acceptance criteria were met, verifying the performance and supporting substantial equivalence.

Here's a summary of the available information and a structured table for acceptance criteria, acknowledging the lack of specific numerical performance data within this summary:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (as implied)	Reported Device Performance
Material Composition	Conformance to ISO 5832-9 for forged stainless steel	"made of the same materials as the Quadra C femoral stems"
General Design	Maintenance of general design principles of predicate device	"same general design as the Quadra C femoral stems"
Compatibilities	Compatibility with existing Medacta Total Hip Prosthesis System components	"same compatibilities as the Quadra C femoral stems"
Mechanical Endurance	Meeting endurance standards for neck and stem regions	"endurance testing of the neck and stem regions...met all acceptance criteria"
Range of Motion	Unspecified range of motion standards	"range of motion analysis...met all acceptance criteria"
Risk Analysis	No new unacceptable risks identified from modifications	"risk analysis to identify any new risks...design verification was conducted"
Overall Performance	Meeting all pre-defined acceptance criteria based on standards and FDA guidance	"design verification activities met all acceptance criteria and verified the performance"

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

Not applicable. This document describes bench testing for a medical device rather than a clinical study involving human data. The testing was conducted on "worst case based on engineering analysis."

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

Not applicable. Ground truth, in the context of this device, refers to meeting established engineering and material standards for the implant, not to expert interpretation of medical images or patient outcomes.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods are typically relevant for clinical studies or studies involving human judgment (e.g., image interpretation), which is not the nature of this submission. The "adjudication" here would be the verification against predefined engineering acceptance criteria.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No. This is a 510(k) submission for a hip prosthesis, focusing on substantial equivalence through bench testing, not a clinical effectiveness study involving human readers or AI.

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

Yes, in a sense. The "performance testing" described is for the device itself (the femoral stem), without human interaction in its functional evaluation. The testing verifies the physical and mechanical properties of the implant.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance testing is adherence to established engineering standards and FDA guidance documents for hip prostheses, covering aspects like material properties, mechanical strength, endurance, and design specifications. This ensures the device is mechanically sound and safe for its intended use.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device; therefore, there is no "training set" in that context. The "training" for such a device would involve its design and manufacturing processes, which are guided by established engineering principles and standards.

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

Not applicable, as there is no "training set" in the AI/ML sense. The design and manufacturing of the device are based on long-standing medical device engineering principles, material science, biomechanics, and ISO standards (e.g., ISO 5832-9 mentioned for stainless steel). The "ground truth" here is derived from scientific and engineering knowledge accumulated over time regarding safe and effective hip prostheses.

Summary

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510(k) Summary

Manufacturer: Medacta International SA Strada Regina 6874 Castel San Pietro (CH) Switzerland Phone (+41) 91 696 60 60 FAX (+41) 91 696 60 66

Contact Person: Ms. Natalie J. Kennel 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
Date Prepared: October 25, 2010

DEVICE INFORMATION

Trade/Proprietary Name: AMIStem C & Quadra C SN femoral stems Common Name /Classification Name: Hip joint, femoral metal/ ceramic, polvmer semiconstrained metallic cemented or uncemented prosthesis

21 CFR 888.3360 Class II Device Product Code: LZO. JDI

Predicate Devices: Medacta Total Hip Prosthesis system - Quadra C. Medacta International cleared under K083558.

Product Description:

Section 5 - Page 1 of 3

K103189(pg1/3)

DEC 2 0 2010

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stems are based on the design of the Quadra C femoral stems in the original submission. The AMIStem C femoral stems differ from the Quadra C femoral stems by a decreased length of 15% and a reduced shoulder. The Quadra C short neck femoral stems are the same design femoral stems as the Quadra C femoral stems in the original submission but the length of the neck that is 5 mm shorter.

Like the Quadra C femoral stems, the AMIStem C femoral stems and the Quadra C SN femoral stems are highly polished, collarless femoral components manufactured from forged stainless steel according to ISO 5832-9. The AMIStem C femoral stems and the Quadra C SN femoral stems are straight quadratic stems with a triple taper shape. The proximal portion of the stem has a standard 12/14 taper for mechanical attachment to cleared Medacta International metallic or ceramic femoral heads.

Like the Quadra C femoral stems, two different caput-collum-diaphyseal angles (CCD) are available for the AMIStem C femoral stems and the Quadra C Short neck femoral stems: 135° for the standard offset and 127° for the lateralized offset. The Quadra C short neck femoral stems come in eight sizes with a standard offset and seven sizes with a lateral offset. The AMIStem C femoral stems come in eight sizes with a standard offset and seven sizes with a lateral offset. There are no short neck versions for the AMIStem C femoral stems.

The AMIStem C femoral stems and the Quadra C short neck femoral stems provide additional femoral stem options to the surgeon for use with the Medacta Total Hip Prosthesis System.

Indications for Use:

The Medacta Total Hip Prosthesis System - Quadra C Femoral Stems are intended for cemented 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.

Size 0 implants should not be implanted in patients with a mass of 65 kg or greater.

Comparison to Predicate Devices:

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The Medacta Total Hip Prosthesis System- AMIStem C femoral stems and Quadra C short neck femoral stems are substantially equivalent to the Medacta Total Hip Prosthesis system - Quadra C, cleared under K083558.

The AMIStem C femoral stems and the Quadra C short neck femoral stems are made of the same materials as the Quadra C femoral stems in the predicate device. They have the same general design as the Quadra C femoral stems. They have the same compatibilities as the Quadra C femoral stems.

Performance Testing

No performance standards applicable to this device have been adopted under Section 514 of the Food, Drug and Cosmetic Act. Performance testing of the AMIStem C and Quadra C Short neck femoral stems was conducted in accordance with various standards and FDA guidance documents. A detailed list is provided in Section 18 Performance Testing - Bench.

The modifications to the device system to include the addition of AMIStem C and Quadra C short neck femoral stems were evaluated by risk analysis to identify any new risks associated with these changes. Based on the risk analysis, design verification was conducted to written protocols with predefined acceptance criteria. The protocols and pre-defined acceptance criteria were based on the standards and FDA guidance. The testing was conducted on the worst case based on engineering analysis. The testing included endurance testing of the neck and stem regions of the femoral components as well as range of motion analysis. The design verification activities met all acceptance criteria and verified the performance of the Medacta Total Hip Prosthesis System - AMIStem C femoral stems and Quadra C short neck femoral stems.

Conclusion:

The results from the design control activities and the information provided in this submission support the conclusion that the Medacta Total Hip Prosthesis system - AMIStem C femoral stems and Quadra C short neck femoral stems . are substantially equivalent to its predicate device, Medacta Total Hip Prosthesis Quadra C femoral stems with respect to indications for use and technological characteristics.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

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

DEC 2 0 2010

Re: K0103189

Trade/Device Name: Medacta Total Hip Prosthesis – AMIStem C, Quadra C SN Regulation Number: 21 CFR 888.3360 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis

Regulatory Class: Class II Product Code: LZO, JDI Dated: November 30, 2010 Received: December 1, 2010

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is elabilitional 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 I hat FDA has made a determination that your device complies with other requirements of the Act that 1 27 Thus Intatutes and regulations administered by other Federal agencies. You must or any I ederal state Act's requirements, including, but not limited to: registration and listing (21

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Page 2 – Ms. Natalie J. Kennel

comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/wcm115809.html for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,
AK B. R. h

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative 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): K103189 (pg 1/1)

Device Name: AMIStem C & Quadra C SN

Indications for Use:

The Medacta Total Hip Prosthesis System – Quadra C Femoral Stems are intended for cemented 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.

Size 0 implants should not be implanted in patients with a mass of 65 kg or greater.

Prescription Use × (Part 21 CFR 801 Subpart D)

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

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

510(k) Number

Concurrence of CDRH, Office of Device Evaluation (ODE)

for M. Melkerm

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

Page of

Regulation Number and Section

§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.

(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.