The Exeter X3 RimFit Acetabular Cup 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 femoral heads includes: V40 and C-Taper (LFITM, CoCr, Biolox delta, Alumina, and Orthinox).

The indications for use of total hip replacement prostheses include:

Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis.
Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
Where bone stock is of poor quality or inadequate for other reconstructive techniques, such as cementless fixation, as indicated by deficiencies of the acetabulum

Stryker's Exeter X3 RimFit Acetabular Cup is intended for cemented use only.

Device Description

This Traditional 510(k) submission is being supplied to the U.S. FDA to provide authorization to market the new Exeter X3 RimFit Acetabular Cup manufactured from a modified sequentially crosslinked and annealed Ultra High Molecular Weight Polyethylene (UHMWPE) material. The proprietary name of the subject polyethylene material is X3® UHMWPE.

AI/ML Overview

The Exeter X3 RimFit Acetabular Cup is a hip prosthesis, and its acceptance criteria and the study proving it meets these criteria are outlined in the provided 510(k) submission.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (from FDA Guidance Document "Class II Special Controls Guidance Document: Hip Joint Metal/Polymer Constrained Cemented or Uncemented Prosthesis (April 30, 2002)")	Reported Device Performance
Mechanical integrity under Lever-out post fatigue testing	Demonstrated substantial equivalence to devices currently cleared for marketing.
Mechanical strength under Pull-out testing (on cement spacers)	Demonstrated substantial equivalence to devices currently cleared for marketing.

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

Test Set Sample Size: Not explicitly stated as a numerical sample size. The testing involved "worst-case size determined by Finite Element Analysis" for the lever-out post fatigue testing. For pull-out testing, it was performed on "cement spacers." The details on the number of specimens tested for each are not provided.
Data Provenance: The data is from "Non-clinical laboratory testing" performed by the manufacturer, Howmedica Osteonics Corp. This is retrospective, in-house testing designed to demonstrate substantial equivalence to predicate devices. The country of origin for the testing itself is not specified but is implicit to the submitting company (based in Mahwah, NJ, USA).

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

Not applicable. This device is a mechanical implant, and its performance criteria are based on engineering specifications and mechanical testing, not on expert interpretation of observational data.

4. Adjudication Method for the Test Set

Not applicable. The test set involves mechanical engineering tests, not human judgment, and thus does not require an adjudication method.

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

No, an MRMC comparative effectiveness study was not done. The device is a physical hip prosthesis, not an imaging or diagnostic AI tool that would involve human readers.

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

Yes, in a conceptual sense. The "standalone" performance here refers to the physical device's mechanical properties, which were tested independently without human interaction during the actual performance measurement (other than setting up and operating the testing equipment). The testing was "algorithm only" in that it assessed the device against pre-defined mechanical engineering specifications.

7. The Type of Ground Truth Used

The ground truth used for mechanical testing is based on:

Established engineering specifications and performance standards outlined in the "FDA Guidance Document entitled 'Class II Special Controls Guidance Document: Hip Joint Metal/Polymer Constrained Cemented or Uncemented Prosthesis (April 30, 2002)'".
Performance of predicate devices (The Trident All Poly Cup, Trident X3 Acetabular Insert, Exeter Hip System With V40 Taper and the Opera Cup). The tests demonstrated "substantial equivalence" to these predicate devices, implying these predicate devices' established performance serves as a comparative ground truth.

8. The Sample Size for the Training Set

Not applicable. This is a medical device (hip prosthesis), undergoes mechanical testing, and does not involve AI/machine learning, therefore there is no "training set."

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

Not applicable, as there is no training set for this type of device.

Summary

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KIII 848

Proprietary Name:	Exeter X3 RimFit Acetabular Cup
Common Name:	Hip prosthesis
Classification Name and Reference:	Hip joint metal/polymer semi-constrained cementedprosthesis 21 CFR §888.3350
Regulatory Class:	Class II
Product Codes:	87 JDI - prosthesis, hip, semi-constrained, metal/polymer,cemented
For Information contact:	Estela Celi, Regulatory Affairs AssociateHowmedica Osteonics Corp.325 Corporate DriveMahwah, NJ 07430Phone: (201) 831-6461 Fax: (201) 831-3461
Date Prepared:	August 16, 2011

510(k) Summary of Safety and Effectiveness

Description:

Intended Use:

Page 1 of 2

OCT - 5 2011

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KIII 848

Indications:

The indications for use of total hip replacement prostheses include:

Painful, disabling joint disease of the hip resulting from: degenerative arthritis, ● rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis.
Revision of previous unsuccessful femoral head replacement, cup arthroplasty or . other procedure.
Clinical management problems where arthrodesis or alternative reconstructive . techniques are less likely to achieve satisfactory results.
· Where bone stock is of poor quality or inadequate for other reconstructive techniques, such as cementless fixation, as indicated by deficiencies of the acetabulum

Stryker's Exeter X3 RimFit Acetabular Cup is intended for cemented use only.

Summary of Technologies:

Device comparison showed that the proposed device is substantially equivalent in intended, use, materials and performance characteristics to the predicate device. The predicate devices used for comparison to the proposed device are the following; The Trident All Poly Cup, Trident X3 Acetabular Insert, Exeter Hip System With V40 Taper and the Opera Cup (Smith & Nephew).

Non-Clinical Testing:

Non-clinical laboratory testing was performed for the acetabular cup to determine substantial equivalence. Non-clinical testing was provided as outlined in the FDA Guidance Document entitled "Class II Special Controls Guidance Document: Hip Joint Metal/Polymer Constrained Cemented or Uncemented Prosthesis (April 30, 2002)". Lever-out post fatigue testing was conducted on the worst-case size determined by Finite Element Analysis. Pull-out testing was performed on the cement spacers in order to evaluate their mechanical strength. The testing demonstrated that the Exeter X3 RimFit Acetabular Cup is substantially equivalent to devices currently cleared for marketing.

Clinical Testing: Clinical testing was not required for this submission.

Conclusion: The Exeter X3 RimFit Acetabular Cup is substantially equivalent to the predicate devices identified in this premarket notification.

Page 2 of 2

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Image /page/2/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling three human figures connected by flowing lines, creating a sense of unity and movement.

Food and Drug Administration 19903 New Hampshire Avenue Document Control Room -- W()66-G609 Silver Spring, MD 20903-0002

Howmedica Osteonics Corporation % Ms. Estela Celi Regulatory Affairs Associate 325 Corporate Drive Mahwah. New Jersev 07430

5 2011

Re: K111848

Trade/Device Name: X3 RimFit Acetabular Cup Regulation Number: 21 CFR 888.3350 Regulation Name: Hip joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JDI Dated: August 16. 2011 Received: August 17, 2011

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. 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 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Ms. Estela Celi

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.

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/Reportal?roblem/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/Industrv/default.hum.

Sincerely yours.

for Tho

Nro. Luv

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): K111848

Device Name: Exeter X3 RimFit Acetabular Cup

Indications for Use:

The indications for use of the total hip arthoplasty include:

Painful, disabling joint disease of the hip resulting from: degenerative arthritis, . rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis.
Revision of previous unsuccessful femoral head replacement, cup arthroplasty or . other procedure.
Clinical management problems where arthrodesis or alternative reconstructive . techniques are less likely to achieve satisfactory results.
Where bone stock is of poor quality or inadequate for other reconstructive techniques, . such as cementless fixation, as indicated by deficiencies of the acetabulum

Stryker's Exeter X3 RimFit Acetabular Cup is intended for cemented use only.

Prescription Use X Over-The-Counter Use 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)

Mitchel Thomas for MXM

(Division Sign-Oft) Division of Surgical, Orthopedic, and Resiorative Devices

510(k) Number K111848

Page 1 of 1

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.