REJUVENATE MONOLITHIC SIZE 4 HIP STEM

K091161 · Howmedica Osteonics Corp. · MEH · Jun 16, 2009 · Orthopedic

Device Facts

• Record ID: K091161
• Device Name: REJUVENATE MONOLITHIC SIZE 4 HIP STEM
• Applicant: Howmedica Osteonics Corp.
• Product Code: MEH · Orthopedic
• Decision Date: Jun 16, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3353
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

Rejuvenate Monolithic Size 4 Hip Stem is a femoral component for total hip arthroplasty. Device is implanted via cementless, press-fit application into the femur. It functions as a structural replacement for the femoral head and neck, articulating with compatible acetabular components and femoral heads. Used by orthopedic surgeons in clinical settings. Provides mechanical stability to the hip joint; restores joint function; alleviates pain. Benefits patients by replacing diseased or fractured bone tissue with a prosthetic implant.

Clinical Evidence

No clinical data; substantial equivalence based on design, material, and mechanical testing similarities to the predicate system.

Technological Characteristics

Monolithic hip stem for cementless, press-fit application. Designed for compatibility with Howmedica Osteonics acetabular components, V40 femoral heads, V40/C-Taper Alumina heads, and Biolox® Delta Universal Taper Heads. Sterile, single-use device.

Indications for Use

Indicated for patients requiring total hip replacement due to noninflammatory degenerative joint disease (osteoarthritis, avascular necrosis), rheumatoid arthritis, functional deformity, failed previous treatments/devices, or nonunion, femoral neck, and trochanteric fractures of the proximal femur with head involvement. Intended for cementless use only.

Regulatory Classification

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.

Predicate Devices

• Rejuvenate Monolithic Hip System (K091161)

Submission Summary (Full Text)

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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

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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: [phone] Fax: [phone]

Date Prepared:

April 20, 2009

#### 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.

#### 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.

#### Indications:

The indications for use of total hip replacement prostheses include:

- Noninflammatory degenerative joint disease including osteoarthritis and avascular I) necrosis:
- 2) Rheumatoid arthritis;
- 3) Correction of functional deformity;
- 4) 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.

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### 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.

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#### 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.

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#### 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 [phone]. 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 [phone]. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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 [phone] or [phone] 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

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#### 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:
- 2) Rheumatoid arthritis
- 3) 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

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