The Rejuvenate™ 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 acctabular 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.

This hip is intended for cementless use only.

Device Description

This Special 510(k) submission is a line extension to address modifications to the Rejuvenate™ Modular Hip System. This line extension extends the combined head/neck length options.

AI/ML Overview

This is a 510(k) premarket notification for a hip prosthesis, Rejuvenate™ Modular Hip System. The provided text is a summary of safety and effectiveness. It describes a medical device, not an AI/ML powered device, therefore, a study that proves the device meets the acceptance criteria is not applicable in the typical sense of AI/ML performance metrics.

The submission establishes substantial equivalence to existing predicate devices based on intended use, design, materials, and operational principles, rather than performance against specific acceptance criteria derived from a clinical or diagnostic study with a test set, ground truth, and human reader comparisons.

Therefore, many of your requested points are not relevant to this type of regulatory submission. I will address the relevant points and indicate where information is not available or applicable.

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

For this medical device (a hip prosthesis), "acceptance criteria" are not defined as performance metrics like sensitivity, specificity, or AUC, as would be the case for an AI/ML diagnostic. Instead, the acceptance criteria are met by demonstrating substantial equivalence to legally marketed predicate devices. The "reported device performance" in this context refers to the device's characteristics (design, materials, intended use, indications) that are compared to the predicate.

Acceptance Criteria (Demonstration of Substantial Equivalence to Predicate Devices K071082 and K081044)	Reported Device Performance (Rejuvenate™ Modular Hip System Line Extension)
Same Intended Use	"intended for use in primary and revision total hip arthroplasty to alleviate pain and restore function"
Same Indications for Use	Noninflammatory degenerative joint disease (osteoarthritis, avascular necrosis), rheumatoid arthritis, correction of functional deformity, revision procedures, treatment of nonunion/fractures. Intended for cementless use only.
Similar Design Principles	Line extension to address modifications to combined head/neck length options for a modular hip system.
Similar Materials	(Implied to be similar to legally marketed predicate devices, not explicitly detailed in this summary)
Similar Operational Principles	(Implied to be similar, not explicitly detailed in this summary)

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. This is not an AI/ML study involving a test set of data. The submission relies on comparative analysis with predicate devices and possibly bench testing (though not detailed in this summary) to demonstrate substantial equivalence for a physical medical implant.

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 "ground truth" establishment in the context of a diagnostic test for this type of medical device submission.

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

Not applicable.

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 is not an AI-assisted device.

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

Not applicable.

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

Not applicable. The "truth" in this context is established by the safety and effectiveness profile of the predicate devices.

8. The sample size for the training set

Not applicable. This is not an AI/ML product developed with a training set.

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

Not applicable.

Summary

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K092561

OCT 2 0 2009

Summary of Safety and Effectiveness Rejuvenate™ Modular Hip System Line Extension

Proprietary Name:	Rejuvenate™ Modular Stem
Common Name:	Hip prosthesis
Classification Name and Reference:	Hip joint metal/ceramic/polymer semiconstrained cemented ornonporous uncemented prosthesis, 21 CFR §888.3353
	Hip joint metal/polymer/metal semiconstrained porous coateduncemented prosthesis, 21 CFR §888.3358
	Hip joint metal/polymer semiconstrained cemented prosthesis21CFR §888.3350
	Hip joint femoral (hemihip) metal/polymer cemented oruncemented prosthesis. 21 CFR §888.3390
	Hip joint metal/polymer constrained cemented or uncementedprosthesis. 21 CFR §888.3310
	Hip joint femoral (hemi-hip) metallic cemented or uncementedprosthesis. 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 nonporous, 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 or uncemented,metal/polymer
	87 KWL - prosthesis, hip, hemi-, femoral, metal
	87 LWJ - prosthesis, hip, semi-constrained, metal/polymer,uncemented

Page 1 of 2

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K092561

For Information contact:

Estela Celi, Regulatory Affairs Associate Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 Phone: (201) 831-6461 Fax: (201) 831-6038

Date Prepared:

August 17, 2009

Description:

This Special 510(k) submission is a line extension to address modifications to the Rejuvenate™ Modular Hip System. This line extension extends the combined head/neck length options.

Intended Use

Indications

The indications for use of total hip replacement prostheses include:

Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis; 1)
1. Rheumatoid arthritis;
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 with head 5) involvement that are unmanageable using other techniques.

This hip is intended for cementless use only.

Substantial Equivalence:

With the addition of this line extension The Rejuvenate™ Modular Hip System is substantially equivalent to the Stryker Modular Hip cleared under K071082 and Rejuvenate™ Modular Hip System cleared under K081044 in regards to intended use, design, materials, and operational principles as a hip prosthesis.

Page 2 of 2

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DEPARTMENT OF HEAL.TH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three stylized lines.

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

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

OCT 20 2009

Re: K092561

Trade/Device Name: Rejuvenate™ Modular Hip System Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prothesis Regulatory Class: II Product Code: MEH, LZO, LPH, JDI, KWY, KWZ, KWL, LWJ Dated: August 17, 2009 Received: September 21, 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 (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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mark N Millman

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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K09256

Indications for Use

510(k) Number (if known):

Device Name: Rejuvenate™ Modular Hip System

Indications for Use:

The indications for use of total hip replacement prostheses include:

Noninflammatory degenerative joint disease including osteoarthritis and avascular 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 with head ર) involvement that are unmanageable using other techniques.

This hip 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)

Omettu for MXOL

(Division Sign-Of Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K092561

Page 1 of 1

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.