RESTORATION MODULAR SYSTEM

K022549 · Howmedica Osteonics Corp. · LZO · Sep 23, 2002 · Orthopedic

Device Facts

• Record ID: K022549
• Device Name: RESTORATION MODULAR SYSTEM
• Applicant: Howmedica Osteonics Corp.
• Product Code: LZO · Orthopedic
• Decision Date: Sep 23, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3353
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

This system is intended to be used for primary or revision total hip arthroplasty, as well as in the presence of severe proximal bone loss. The stems are intended to be used with Howmedica Osteonics femoral heads, unipolar and bipolar components, and acetabular components. These femoral stems are designed to be press fit into the proximal femur.

Device Story

Restoration™ Modular System is a 2-piece modular femoral hip prosthesis; consists of proximal body, distal stem, and locking bolt. Surgeon assembles components in OR or in situ to allow independent sizing of proximal and distal segments. Designed for press-fit fixation into proximal femur. Used in primary or revision total hip arthroplasty, including cases of severe proximal bone loss. Compatible with Howmedica Osteonics femoral heads, unipolar/bipolar components, and acetabular components. Provides flexibility in implant sizing to address patient-specific anatomy.

Clinical Evidence

Bench testing only. Fatigue testing performed on neck, proximal body, and distal stem components. Test methods consistent with ISO 7206-4 and ISO 7206-6. Results demonstrate mechanical properties meet or exceed defined performance values.

Technological Characteristics

Materials: Titanium (Ti6Al-4V) alloy. Surface treatments: plasma spray or plasma spray with hydroxylapatite coatings. Modular junction design. Standards: ISO 7206-4, ISO 7206-6. Non-sterile (implied by assembly in OR).

Indications for Use

Indicated for patients requiring primary or revision total hip arthroplasty, including those with severe proximal bone loss.

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

• Restoration™ Modular (2 Piece Modular System) (K013106)

Submission Summary (Full Text)

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022549 page 1 of 2

### 510(k) Summary for the Restoration™ Modular System (Device Modification for the 2 Piece Modular Revision Stem System)

| Proprietary Name: | Restoration™ Modular System |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------|
| Common Name: | Femoral Hip Prosthesis |
| Classification Name and Reference: | 21 CFR 888.3353<br>Hip joint metal/ceramic/polymer semi-constrained cemented or<br>nonporous uncemented prosthesis |
| Proposed Regulatory Class: | II |
| Device Product Code: | OR(87) LZO |
| For Information contact: | Jennifer A. Daudelin |
| | Regulatory Affairs Specialist |
| | Howmedica Osteonics Corp. |
| | 59 Route 17 |
| | Allendale, NJ 07401-1677 |
| | [phone] |
| | Fax: [phone] |
| Date Summary Prepared: | July 31, 2002 |

SEP 23 2002#### Device Description

The 2 Piece Modular Hip Stem, hereby referred to as the Restoration™ Modular System, is a modular system comprised of a proximal body, distal stem, and locking bolt. These three individual components utilizing a modular junction are assembled by the surgeon in the operating room or in situ to allow independent sizing of the proximal body and distal This system is designed so that all proximal components will be able to mate with stem. all distal components, thus affording optimal flexibility.

The Restoration™ Modular System components will be fabricated from Titanium (Ti6Al-4V) Alloy. The Cone and Broached body components as well as the Porous Stems will be offered with plasma spray or plasma spray and hydroxylapatite coatings.

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022549 page 2 of 2

#### Intended Use

This system is intended to be used for primary or revision total hip arthroplasty, as well as in the presence of severe proximal bone loss. The stems are intended to be used with Howmedica Osteonics femoral heads, unipolar and bipolar components, and acetabular components. These femoral stems are designed to be press fit into the proximal femur.

### Substantial Equivalence

The substantial equivalence of the Restoration™ Modular System is based upon equivalence in intended use, materials, and design to the following Howmedica Osteonics device: Restoration™ Modular (2 Piece Modular System) (K013106).

#### Performance Data

A series of fatigue tests were performed to ensure the integrity of the Restoration™ Modular System. Testing was performed to evaluate the strength of the neck, proximal body, and distal stem regions of the system. "Most severe case" components/assemblies were tested based upon the previous FEA results. Test methods were consistent with methods described in ISO 7206-4 and ISO 7206-6. The comparison of test results with defined performance criteria indicate that all tested components meet or exceed their defined performance values. In summary, the testing demonstrates that, in terms of mechanical properties, the modified Restoration™ Modular Components are substantially equivalent to the legally marketed predicate components in terms of safety and effectiveness.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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SEP 2 3 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Jennifer A. Daudelin Regulatory Affairs Specialist Howmedica Osteonics Corp. 59 Route 17 Allendale, New Jersey 07401-1677

Re: K022549

Trade Name: Restoration™ Modular System Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or Porous uncemented prosthesis Regulatory Class:II Product Code: LZO Dated: July 31, 2002

Dear Ms. Daudelin:

Received: August 1, 2002

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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. Jennifer A. Daudelin

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

R. Mark A. Wilkerson

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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022549

Indications for Use

510(k) Number (if known):

Device Name:

Indications for Use:

The Restoration™ Modular System is intended to be used for primary or revision total hip arthroplasty, as well as in the presence of severe proximal bone loss. The stems are intended to be used with Howmedica Osteonics femoral heads, unipolar and bipolar components, and acetabular components. These femoral stems are designed to be press fit into the proximal femur.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use

for Mark N. Mulhearn (Optional Format 1-2-96)
(Division Sign-Off)

(Division Sign-Off)
Division of General, Restorative
and Neurological Devices

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