K Number

Device Name

Manufacturer

HOWMEDICA OSTEONICS CORP

Date Cleared

2009-06-16

(56 days)

Product Code

MEH,JDI,KWY,KWZ,LPH,LWJ,LZO

Regulation Number

888.3353

Type

Traditional

Panel

Orthopedic

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

The Rejuvenate Monolithic size 4 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; V40 femoral heads, V40 Alumina 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 the 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 is unmanageable using other techniques.
Stryker's Rejuvenate Hip System is intended for cementless use only.

Device Description

The Rejuvenate Monolithic Size 4 Hip stem is part of the previously cleared Rejuvenate Monolithic Hip System. The size 4 monolithic hip stem is intended for cementless. press-fit application. It is designed for use with the available compatible Howmedica Osteonics' femoral heads, bipolars and their compatible acetabular components.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Rejuvenate Monolithic Size 4 Hip Stem:

Analysis:

This submission is a 510(k) Premarket Notification for a medical device. In 510(k) submissions, the primary "study" that proves the device meets acceptance criteria is often a demonstration of substantial equivalence to an already legally marketed (predicate) device. The acceptance criteria are therefore implicitly the performance characteristics and safety profile of the predicate device.

The provided document does not contain explicit performance acceptance criteria or a formal clinical study report with the specific details requested in your prompt (e.g., sample sizes, expert qualifications, MRMC studies, standalone algorithm performance, training set details). Instead, it focuses on the device's description, intended use, indications for use, and the declaration of substantial equivalence.

Here's a breakdown based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implicit)	Reported Device Performance
Material Properties: Comparable to predicate device.	"The Rejuvenate Monolithic Hip Size 4 Hip Stem is identical to the stems which are part of the previously submitted Rejuvenate Monolithic Hip System in regard to ... materials..."
Mechanical Testing Performance: Comparable to predicate device.	"The Rejuvenate Monolithic Hip Size 4 Hip Stem is identical to the stems which are part of the previously submitted Rejuvenate Monolithic Hip System in regard to ... mechanical testing..."
Design: Comparable to predicate device.	"The Rejuvenate Monolithic Hip Size 4 Hip Stem is identical to the stems which are part of the previously submitted Rejuvenate Monolithic Hip System in regard to ... design..."
Intended Use: Identical to predicate device.	"The Rejuvenate Monolithic Hip Size 4 Hip Stem is identical to the stems which are part of the previously submitted Rejuvenate Monolithic Hip System in regard to intended use..." The stated intended use for the new device is: "sterile, single-use device intended for use in primary and revision total hip arthroplasty to alleviate pain and restore function" in cementless press-fit application.
Operational Principles: Identical to predicate device.	"The Rejuvenate Monolithic Hip Size 4 Hip Stem is identical to the stems which are part of the previously submitted Rejuvenate Monolithic Hip System in regard to ... operational principles as a hip prosthesis."
Safety and Effectiveness: Substantially equivalent to predicate device.	The FDA's letter (K091161) states: "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 uses stated in the enclosure) to legally marketed predicate devices..."

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

Not Applicable. This document describes a 510(k) submission based on substantial equivalence, not a clinical trial with a "test set" in the context of AI or advanced statistical validation. The "study" here is the comparison to a predicate device.
The "data provenance" would refer to the technical and performance data of the predicate device, which is not detailed in this summary.

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

Not Applicable. Since there isn't a "test set" or a new diagnostic algorithm being evaluated for accuracy against established ground truth in the AI sense, this information is not relevant to this type of device submission.
The closest "experts" involved are the FDA reviewers who assessed the substantial equivalence claim.

4. Adjudication Method for the Test Set

Not Applicable. See point 3.

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 a hip stem (implantable medical device), not an AI-powered diagnostic or assistive tool. MRMC studies are not relevant here.

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

Not Applicable. This is not an algorithm or AI device.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

Substantial Equivalence to a Predicate Device. The "ground truth" for a 510(k) submission like this is the established safety and effectiveness of the legally marketed predicate device(s). The new device is deemed acceptable if it can demonstrate it performs equivalently and raises no new questions of safety or effectiveness.

8. The Sample Size for the Training Set

Not Applicable. There is no "training set" in the context of an AI device for this hip stem. The development of the device would involve engineering design, materials science, and mechanical testing, not machine learning training.

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

Not Applicable. See point 8.

Summary of the "Study" and Acceptance Criteria:

The "study" presented in this 510(k) document is the demonstration of substantial equivalence to existing legally marketed predicate devices. The acceptance criteria are, implicitly, that the new device (Rejuvenate Monolithic Size 4 Hip Stem) is identical in intended use, design, materials, mechanical testing, and operational principles to a previously cleared device within the Rejuvenate Monolithic Hip System. The FDA concurred with this assessment, officially concluding that the device is substantially equivalent to legally marketed predicate devices. This means that the device is considered as safe and effective as the predicate devices without needing independent clinical trials or detailed performance metrics as would be required for a novel device or an AI/diagnostic tool.

Summary

{0}------------------------------------------------

K091161 (pg 1/3)

510(k) Summary of Safety and Effectiveness

JUN 1 6 2009

Proprietary Name:

Rejuvenate Monolithic Size 4 Hip Stem

Common Name:

Hip prosthesis

Classification Name and Reference: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis, 21 CFR §888.3353

Hip joint metal/polymer/metal semi-constrained porous coated uncemented prosthesis, 21 CFR 888.3358

Hip joint metal/polymer semi-constrained cemented prosthesis 21 CFR §888.3350

Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis. 21 CFR 888.3390

Hip joint metal/polymer constrained cemented or uncemented prosthesis. 21 CFR §888.3310

Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis. 21 CFR §888.3360

Regulatory Class:

Product Codes:

Class II

87 MEH - prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calciumphosphate

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

{1}------------------------------------------------

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

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:

April 20, 2009

Description:

Intended Use:

Indications:

The indications for use of total hip replacement prostheses include:

Noninflammatory degenerative joint disease including osteoarthritis and avascular I) necrosis:
1. Rheumatoid arthritis;
1. Correction of functional deformity;
1. Revision procedures where other treatments or devices have failed: and.
ર) Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that is unmanageable using other techniques.
() Stryker's Rejuvenate Hip System is intended for cementless use only.

{2}------------------------------------------------

Substantial Equivalence:

The Rejuvenate Monolithic Hip Size 4 Hip Stem is identical to the stems which are part of the previously submitted Rejuvenate Monolithic Hip System in regard to intended use, design, materials, mechanical testing and operational principles as a hip prosthesis.

{3}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

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" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Howmedica Osteonics Corp. % Ms: Estela Celi Regulatory Affairs Associate 325 Corporate Dr. Mahwah, New Jersey 07430

JUN 1 6 2009

Re: K091161

Trade/Device Name: Rejuvenate Monolithic Size 4 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: April 20, 2009 Received: April 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 ucurec 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, Or to 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 I (1 MThe general controls provisions of the Act include requirements for annual registration, l'isting 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 not incum 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.

{4}------------------------------------------------

Page 2 - Ms. Estela Celi

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 vours.

Barbara Buchus

Mark N. Melkerso Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

Indications for Use

510(k) Number (if known): Yogyllel (pq 1/1)

Device Name: Rejuvenate Monolithic Size 4 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:
1. Rheumatoid arthritis
1. Correction of functional deformity;
Revision procedures where other treatments or devices have failed; and, 4)
5). H Treatment of nonunion, femoral neck and trochanteric fractures of the proximal * femur with head involvement that are unmanageable using other techniques.
Stryker's Rejuvenate Hip System is intended for cementless 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)

Scuta
B-(Division Sign-Off)

Division of Surgical, Orthopedic

Restorative De

510(k) Number K091161

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.