The ABG™ II Modular Hip Stem 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 compatible Howmedica Osteonics' acetabular components. Compatibility with the modular stems includes: V40 Biolox Delta, Biolox Delta Universal Taper Heads and Sleeves, V40 CoCr Heads, V40 LFIT CoCr Heads, C-Taper Alumina Heads when used with the V40/C-taper Adaptor, C-Taper Delta Heads when used with C-taper Adaptor, UHR Universal Head, Unitrax Heads when used with the Unitrax V40 Modular Adapter.

The indications for use of total hip replacement prostheses include:

Noninflammatory degenerative ioint disease including osteoarthritis and avascular 1) necrosis;
Rheumatoid arthritis; 2)
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 femur 5) with head involvement that is unmanageable using other techniques.

Stryker's ABGTM II Modular Hip Stem is intended for cementless use only.

Device Description

Howmedica Osteonics is introducing a modular hip prosthesis. The basic design of the ABG™ II Modular Hip Stem, referred as the ABG™ II Modular, is similar to other total hip systems commercially distributed such as the Stryker Modular Hip System.

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

AI/ML Overview

This 510(k) summary describes a premarket notification for a hip prosthesis, not an AI/ML medical device. Therefore, many of the requested categories related to performance studies for AI/ML devices (e.g., sample size for training, ground truth establishment, MRMC studies, standalone performance) are not applicable.

The submission focuses on demonstrating substantial equivalence to existing predicate devices based on design, materials, operational principles, and mechanical testing.

Here's an analysis of the provided text in relation to your request, highlighting the applicable information:

1. Table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" in terms of quantitative performance metrics for a diagnostic or AI device. Instead, the main "acceptance criteria" for this hip stem are demonstrating substantial equivalence to predicate devices. The performance is assessed through mechanical testing.

Acceptance Criterion (Implicit)	Reported Device Performance
Substantial Equivalence to Predicate Devices (intended use, design materials, operational principles)	"The ABG™ II Modular Hip Stem...is substantially equivalent to other commercially available hip stems in regard to intended use, design materials and operational principles as a hip prosthesis."
Mechanical Performance Equivalent to Predicate Devices	"Based upon the mechanical testing the ABG™ II Modular Hip Stem is substantially equivalent for its intended use to other press-fit femoral replacement hip stems currently on the market."

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

This information is not provided as this is a mechanical device submission, not a study involving human data or AI algorithms. Mechanical testing usually involves a set number of physical prototypes or simulated models, but the specific "sample size" for these mechanical tests is not detailed in the summary.

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)

This is not applicable. Ground truth, in the context of expert consensus, is relevant for diagnostic or image analysis AI/ML devices. For a hip prosthesis, the "ground truth" relates to its material properties and mechanical integrity, which are evaluated through standardized engineering tests, not expert interpretation of human data.

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

This is not applicable. Adjudication methods are used in studies involving human interpretation or subjective assessments, typically for AI/ML devices.

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

This is not applicable. MRMC studies are specific to evaluating diagnostic AI/ML tools used by human readers. This submission is for a physical medical implant.

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

This is not applicable. "Standalone performance" refers to the performance of an AI algorithm without human interaction. This document describes a physical medical device.

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

As mentioned in point 3, the concept of "ground truth" as typically applied to AI/ML studies is not applicable here. The "truth" for this device is its adherence to mechanical performance standards and material specifications, which are verified through engineering tests and comparison to predicate devices.

8. The sample size for the training set

This is not applicable. There is no AI model or "training set" described in this submission.

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

This is not applicable for the same reasons as point 8.

Summary

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K092406 (pg 1/3)

510(k) Summary of Safety and Effectiveness

Proprietary Name:	ABG™ II Modular Hip Stem NOV - 4 2009
Common Name:	Hip prosthesis
Classification Name and Reference:	Hip joint metal/ceramic/polymer semi-constrainedcemented or nonporous uncemented prosthesis, 21 CFR §888.3353Hip joint metal/polymer/metal semi-constrained porouscoated uncemented prosthesis, 21 CFR §888.3358Hip joint metal/polymer semi-constrained cementedprosthesis 21 CFR §888.3350Hip joint femoral (hemi-hip) metal/polymer cemented oruncemented prosthesis. 21 CFR §888.3390Hip joint metal/polymer constrained cemented oruncemented prosthesis. 21 CFR §888.3310Hip 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-phosphate87 LZO - prosthesis, hip, semi-constrained,metal/ceramic/polymer, cemented or non-porous,uncemented87 LPH - prosthesis, hip, semi-constrained,metal/polymer, porous uncemented87 JDI - prosthesis, hip, semi-constrained,metal/polymer, cemented87 KWY - prosthesis, hip, hemi-, femoral,metal/polymer, cemented or uncemented87 KWZ - prosthesis, hip, constrained, cemented oruncemented, metal/polymer87 KWL - prosthesis, hip, hemi-, femoral, metal

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(K092406 pg 2/3)

87 LWJ - prosthesis. hip. semi-constrained. metal/polymer, uncemented

For Information contact:

Estela Celi, Regulatory Affairs Associate Howmedica Osteonics Corp. 325 Corporate Drive Mahwah. NJ 07430 Phone: (201) 831-6461 Fax: (201) 831-3461

Date Prepared:

. August 8, 2009

Description:

Intended Use:

Indications:

The indications for use of total hip replacement prostheses include:

Noninflammatory degenerative ioint disease including osteoarthritis and avascular 1) necrosis;
Rheumatoid arthritis; 2)
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 femur ર) with head involvement that is unmanageable using other techniques.

Stryker's ABGTM II Modular Hip Stem is intended for cementless use only.

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(K092406 pg 3/3)

Substantial Equivalence:

The ABG™ II Modular Hip Stem, referred to as ABG™ II Modular, is substantially equivalent to other commercially available hip stems in regard to intended use, design materials and operational principles as a hip prosthesis. The following devices are examples of predicate systems; Stryker Modular Hip System and Rejuvenate Monolithic Hip Size 4 Stem. Based upon the mechanical testing the ABG™ II Modular Hip Stem is substantially equivalent for its intended use to other press-fit femoral replacement hip stems currently on the market.

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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, represented by three curved lines that suggest the shape of a bird's head and wings.

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

Howmedica Osteonics Corp % Estela Celi 325 Corporate Drive Mahwah, New Jersey 07430

NOV - 4 2009

Re: K092406 Trade/Device Name: ABG II Modular Hip Stem Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Regulatory Class: Class II Product Code: MEH, LZO, LPH, JDI, KWY, KWZ, KWL, LWJ Dated: August 3, 2009 Received: August 6, 2009

Dear Ms. Celi:

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 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); medical device reporting of medical device-related adverse events) (21 CFR 803); 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. Estela Celi

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/ucm115809.htm 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 (240) 276-3150 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Nil R.S. Oplen

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

510(k) Number (if known): KC92406(pg. 1/1)

Device Name: ABG™ II Modular Hip Stem

Indications for Use:

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

Noninflammatory degenerative joint disease including osteoarthritis and avascular 1) necrosis;
Rheumatoid arthritis 2)
Correction of functional deformity; 3)
Revision procedures where other treatments or devices have failed; and, 4)
Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur 5) with head involvement that are unmanageable using other techniques.

· Stryker's ABG™ II Modular Hip Stem is intended for cementless use only.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Santa for mxm

Wision Sign-Q Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K092406

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.