STRYKER MODULAR HIP SYSTEM

K071082 · Howmedica Osteonics Corp. · LZO · Sep 13, 2007 · Orthopedic

Device Facts

• Record ID: K071082
• Device Name: STRYKER MODULAR HIP SYSTEM
• Applicant: Howmedica Osteonics Corp.
• Product Code: LZO · Orthopedic
• Decision Date: Sep 13, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3353
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Stryker 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 acetabular 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.

Device Story

Modular hip prosthesis system; consists of modular stem and modular neck; designed for cementless, press-fit application in total hip arthroplasty. Used with Howmedica Osteonics femoral heads, bipolars, and compatible acetabular components. Operates as mechanical replacement for hip joint to alleviate pain and restore function. Used by orthopedic surgeons in clinical/surgical settings. Benefits patient by providing structural support and joint mobility in cases of degenerative disease, arthritis, or fracture.

Clinical Evidence

Bench testing only.

Technological Characteristics

Modular hip prosthesis; cementless, press-fit design. Materials include metal/ceramic/polymer components. System utilizes modular stem and neck architecture. Sterilization: sterile, single-use.

Indications for Use

Indicated for patients requiring primary or revision total hip arthroplasty for noninflammatory degenerative joint disease (osteoarthritis, avascular necrosis), rheumatoid arthritis, functional deformity correction, or treatment of nonunion, femoral neck, and trochanteric fractures of the proximal femur with head involvement unmanageable by other techniques. 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

• Profemur Total Hip Modular Neck System (Wright Medical Technology, Inc.)
• Secur-Fit HA Stem (Howmedica Osteonics)
• Accolade C HA Stem (Howmedica Osteonics)
• TMZF HA Stem (Howmedica Osteonics)
• Citation TMZF HA Stem (Howmedica Osteonics)

Submission Summary (Full Text)

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SEP 1 3 2007

# K071082

## 510(k) Summary of Safety and Effectiveness

| Proprietary Name: | Stryker Modular Hip System |
|------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Hip prosthesis |
| Classification Name and Reference: | Hip joint metal/ceramic/polymer semi-constrained<br>cemented or nonporous uncemented prosthesis, 21 CFR<br>§888.3353 |
| | Hip joint metal/polymer/metal semi-constrained porous<br>coated uncemented prosthesis, 21 CFR §888.3358 |
| | Hip joint metal/polymer semi-constrained cemented<br>prosthesis 21 CFR §888.3350 |
| | Hip joint femoral (hemi-hip) metal/polymer cemented or<br>uncemented prosthesis. 21 CFR §888.3390 |
| | Hip joint metal/polymer constrained cemented or<br>uncemented prosthesis. 21 CFR §888.3310 |
| | Hip joint femoral (hemi-hip) metallic cemented or<br>uncemented prosthesis. 21 CFR §888.3360 |
| Regulatory Class: | Class II |
| Product Codes: | 87 MEH - prosthesis, hip, semi-constrained,<br>uncemented, metal/polymer, non-porous, calcium-<br>phosphate |
| | 87 LZO - prosthesis, hip, semi-constrained,<br>metal/ceramic/polymer, cemented or non-porous,<br>uncemented |
| | 87 LPH - prosthesis, hip, semi-constrained,<br>metal/polymer, porous uncemented |
| | 87 JDI - prosthesis, hip, semi-constrained,<br>metal/polymer, cemented |
| | 87 KWY - prosthesis, hip, hemi-, femoral,<br>metal/polymer, cemented or uncemented |
| | 87 KWZ - prosthesis, hip, constrained, cemented or<br>uncemented, metal/polymer |
| | 87 KWL - prosthesis, hip, hemi-, femoral, metal |
| | 87 LWJ - prosthesis, hip, semi-constrained,<br>metal/polymer, uncemented |
| For Information contact: | Vivian Kelly, Senior Regulatory Affairs Specialist<br>Howmedica Osteonics Corp.<br>325 Corporate Drive<br>Mahwah, NJ 07430<br>Phone: [phone] Fax: [phone] |

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September 7, 2007

#### Date Prepared:

#### Description:

Howmedica Osteonics is introducing a modular hip prosthesis. The basic design of the Stryker Modular Hip System is similar to other total hip systems commercially distributed such as the Profemur® Total Hip Modular Neck System, Wright Medical Technology, Inc. and other Howmedica Osteonics' hip systems such as the Secur-Fit HA Stem, the Accolade C and TMZF HA Stems and the Citation TMZF HA Stem.

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

#### Intended Usc

The Stryker 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 acetabular 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.

#### Indications:

The indications for use of 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)
- Treatment of nonunion, femoral neck and trochanteric fractures of the proximal ર) femur with head involvement that are unmanageable using other techniques.

The Stryker Modular Hip System is intended for cementless use only.

#### Substantial Equivalence:

The Stryker Modular Hip is substantially equivalent to other commercially available hip systems in regards to intended use, design, materials, and operational principles as a hip prosthesis. The following devices are examples of predicate systems: the Profemure Total Hip Modular Neck System, Wright Medical Technology, Inc., and other Howmedica Osteonics hip stems such as the Secur-Fit HA Stem, the Accolade C and TMZF HA Stems, and the Citation TMZF HA Stem. Based upon the mechanical testing, the Stryker Modular Hip is substantially equivalent for its intended use to other press-fit femoral replacement hips currently on the market.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized human figure with three arms or lines extending from the head, representing health and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the figure.

Public Health Service

SEP 1 3 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Howmedica Osteonics Corp. c/o Ms. Vivian Kelly, RAC Senior Regulatory Affairs Specialist 325 Corporate Drive Mahwah, New Jersey 07430

Re: K071082 Trade/Device Name: Stryker Modular Hip System Regulation Number: 21 CFR 888.3360 Regulation Name: Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis Regulatory Class: Class II Product Code: LWJ, MEH, LZO, LPH, JDI, KWZ, KWL, KWY Dated: August 24, 2007 Received: August 27, 2007

Dear Ms. Kelly:

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 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 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); 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. Vivian Kelly

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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 yours.

barbere Buehmp

Mark N. Melkers Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Stryker Modular Hip System

Indications for Use:

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

- Noninflammatory degenerative joint disease including ostcoarthritis and avascular ﺮ ﺍﻟﻤﺘﺤﺪﺓ
ﻭﺍﻟﺘﻲ necrosis:
- Rheumatoid arthritis 产品
- Correction of functional deformity; े क
- Revision procedures where other treatments or devices have failed; and, ের মাধ্যমে সামগ্রী সামগ্রী সামগ্রী সামগ্রী সামগ্রী সামগ্রী সামগ্রী সামগ্রী সামগ্রী সামগ্রী সামগ্রী সামগ্রী সামগ্রী সামগ্রী সামগ্রী সামগ্রী সামগ্রী সামগ্রী সামগ্রী সামগ্রী সা
- Treatment of nonunion, femoral neck and trochanteric fractures of the proximal in femur with head involvement that are unmanageable using other techniques.

The Stryker Modular Hip System is intended for cementless use only.

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

Concurrence of CDRH, Office of Device Evaluation

Nbaare fonchm
(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

Page I of I

510(k) Number K071062

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