The Stryker Modular Hip is a sterile, single-use device intended for use in primary and revision total hip arthroplasty to alleviate pain and restore function. This device is intended to be used with any currently available Howmedica Osteonics acetabular components, V40 femoral heads, C-Taper Alumina heads when used with the V40/C-Taper Adaptor and the Biolox® Delta Universal Taper Heads and sleeves.

The indications for use of total hip replacement prostheses include:

Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
Rheumatoid arthritis:
Correction of functional deformity:
Revision procedures where other treatments or devices have failed; and,
Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

The Stryker Modular Hip System is intended for cementless use only.

Device Description

Howmedica Osteonics is introducing a modular hip prosthesis. The basic design of the Stryker Modular Hip System is similar to other total hip systems commercially distributed such as the Profemur® Total Hip Modular Neck System, Wright Medical Technology, Inc. and other Howmedica Osteonics' hip systems such as the Secur-Fit HA Stem, the Accolade C and TMZF HA Stems and the Citation TMZF HA Stem.

The subject hip is a composed of a modular stem with a modular neck intended for cementless, press-fit application. It is designed for use with currently available Howmedica Osteonics' femoral heads, bipolars and their compatible acetabular components.

AI/ML Overview

The provided text is a 510(k) summary for the Stryker Modular Hip System. It describes the device, its intended use, indications, and claims substantial equivalence to predicate devices based on design, materials, and operational principles, supported by mechanical testing.

However, the provided text does not contain any information about specific acceptance criteria or a study demonstrating device performance against those criteria in a clinical or statistical sense. The document focuses on regulatory approval through substantial equivalence, not on a detailed performance study with quantified metrics.

Therefore, I cannot provide the requested table or answer most of the questions about a performance study, as the information is not present in the given document.

Here's a breakdown of what can be extracted and what cannot:

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

Cannot be provided. The document states that the device is "substantially equivalent" to predicate devices based on mechanical testing, but it does not specify any quantitative acceptance criteria (e.g., specific thresholds for wear, fatigue life, or clinical outcome measures) or numerical results from such tests.

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

Cannot be provided. The document mentions "mechanical testing" was performed to establish substantial equivalence but does not specify sample sizes, data provenance, or whether the study was retrospective or prospective. It is highly likely that any "test set" in this context would refer to device components undergoing lab-based mechanical tests, not a patient cohort.

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)

Cannot be provided. There is no mention of human expert involvement in establishing "ground truth" for a test set. The evaluation focuses on mechanical properties, which are typically assessed through laboratory measurements and engineering standards.

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

Cannot be provided. This concept is not applicable to the type of information presented. The document describes a medical device's mechanical testing for regulatory clearance, not a clinical study involving human assessment.

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

Cannot be provided. This document is not about AI or diagnostic imaging. It describes a hip prosthesis.

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

Cannot be provided. This document is not about an algorithm. It describes a hip prosthesis.

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

The "ground truth," in the context of this document, would be based on engineering standards and mechanical test results confirming the physical properties and performance characteristics of the hip prosthesis components. For example, fatigue strength, tensile strength, wear rates, etc., compared to established benchmarks for hip implants. However, specific metrics are not detailed.

8. The sample size for the training set

Not applicable / Cannot be provided. This concept is for AI/machine learning models. The document describes a physical medical device.

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

Not applicable / Cannot be provided. This concept is for AI/machine learning models. The document describes a physical medical device.

In summary: The provided 510(k) summary focuses on demonstrating "substantial equivalence" of the Stryker Modular Hip System to already marketed predicate devices based on design, materials, indications for use, and a general statement about mechanical testing. It does not provide the detailed performance metrics, acceptance criteria, or study design information typically associated with a clinical or performance study as implied by your questions, which are more relevant to AI or diagnostic device evaluations.

Summary

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SEP 1 3 2007

K071082

510(k) Summary of Safety and Effectiveness

Proprietary Name:	Stryker Modular Hip System
Common Name:	Hip prosthesis
Classification Name and Reference:	Hip joint metal/ceramic/polymer semi-constrainedcemented or nonporous uncemented prosthesis, 21 CFR§888.3353
	Hip joint metal/polymer/metal semi-constrained porouscoated uncemented prosthesis, 21 CFR §888.3358
	Hip joint metal/polymer semi-constrained cementedprosthesis 21 CFR §888.3350
	Hip joint femoral (hemi-hip) metal/polymer cemented oruncemented prosthesis. 21 CFR §888.3390
	Hip joint metal/polymer constrained cemented oruncemented prosthesis. 21 CFR §888.3310
	Hip joint femoral (hemi-hip) metallic cemented oruncemented prosthesis. 21 CFR §888.3360
Regulatory Class:	Class II
Product Codes:	87 MEH - prosthesis, hip, semi-constrained,uncemented, metal/polymer, non-porous, calcium-phosphate
	87 LZO - prosthesis, hip, semi-constrained,metal/ceramic/polymer, cemented or non-porous,uncemented
	87 LPH - prosthesis, hip, semi-constrained,metal/polymer, porous uncemented
	87 JDI - prosthesis, hip, semi-constrained,metal/polymer, cemented
	87 KWY - prosthesis, hip, hemi-, femoral,metal/polymer, cemented or uncemented
	87 KWZ - prosthesis, hip, constrained, cemented oruncemented, metal/polymer
	87 KWL - prosthesis, hip, hemi-, femoral, metal
	87 LWJ - prosthesis, hip, semi-constrained,metal/polymer, uncemented
For Information contact:	Vivian Kelly, Senior Regulatory Affairs SpecialistHowmedica Osteonics Corp.325 Corporate DriveMahwah, NJ 07430Phone: (201) 831-5581 Fax: (201) 831-6038

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September 7, 2007

Date Prepared:

Description:

Intended Usc

Indications:

The indications for use of total hip replacement prostheses include:

Noninflammatory degenerative joint disease including osteoarthritis and avascular 1) necrosis;
1. Rheumatoid arthritis:
1. Correction of functional deformity:
Revision procedures where other treatments or devices have failed; and, 4)
Treatment of nonunion, femoral neck and trochanteric fractures of the proximal ર) femur with head involvement that are unmanageable using other techniques.

The Stryker Modular Hip System is intended for cementless use only.

Substantial Equivalence:

The Stryker Modular Hip is substantially equivalent to other commercially available hip systems in regards to intended use, design, materials, and operational principles as a hip prosthesis. The following devices are examples of predicate systems: the Profemure Total Hip Modular Neck System, Wright Medical Technology, Inc., and other Howmedica Osteonics hip stems such as the Secur-Fit HA Stem, the Accolade C and TMZF HA Stems, and the Citation TMZF HA Stem. Based upon the mechanical testing, the Stryker Modular Hip is substantially equivalent for its intended use to other press-fit femoral replacement hips currently on the market.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 stylized human figure with three arms or lines extending from the head, representing health and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the figure.

Public Health Service

SEP 1 3 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Howmedica Osteonics Corp. c/o Ms. Vivian Kelly, RAC Senior Regulatory Affairs Specialist 325 Corporate Drive Mahwah, New Jersey 07430

Re: K071082 Trade/Device Name: Stryker Modular Hip System Regulation Number: 21 CFR 888.3360 Regulation Name: Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis Regulatory Class: Class II Product Code: LWJ, MEH, LZO, LPH, JDI, KWZ, KWL, KWY Dated: August 24, 2007 Received: August 27, 2007

Dear Ms. Kelly:

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. Vivian Kelly

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 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.

barbere Buehmp

Mark N. Melkers 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: Stryker Modular Hip System

Indications for Use:

The indications for use of the total hip replacement prostheses include:

Noninflammatory degenerative joint disease including ostcoarthritis and avascular ﺮ ﺍﻟﻤﺘﺤﺪﺓ
ﻭﺍﻟﺘﻲ necrosis:
Rheumatoid arthritis 产品
Correction of functional deformity; े क
Revision procedures where other treatments or devices have failed; and, ের মাধ্যমে সামগ্রী সামগ্রী সামগ্রী সামগ্রী সামগ্রী সামগ্রী সামগ্রী সামগ্রী সামগ্রী সামগ্রী সামগ্রী সামগ্রী সামগ্রী সামগ্রী সামগ্রী সামগ্রী সামগ্রী সামগ্রী সামগ্রী সামগ্রী সা
Treatment of nonunion, femoral neck and trochanteric fractures of the proximal in femur with head involvement that are unmanageable using other techniques.

The Stryker Modular Hip System is intended for cementless use only.

Over-The-Counter Use Prescription Use AND/OR (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation

Nbaare fonchm
(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

Page I of I

510(k) Number K071062

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.