MODIFICATION TO RESTORATION MODULAR SYSTEM

K040734 · Howmedica Osteonics Corp. · LZO · Aug 25, 2004 · Orthopedic

Device Facts

• Record ID: K040734
• Device Name: MODIFICATION TO RESTORATION MODULAR SYSTEM
• Applicant: Howmedica Osteonics Corp.
• Product Code: LZO · Orthopedic
• Decision Date: Aug 25, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3353
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Restoration® Modular System is intended for primary or revision total hip arthroplasty, as well as in the presence of severe proximal bone loss. These femoral stems are designed to be press fit into the proximal femur. Examples of specific indications for use of the Restorations Modular System include: - . Non-inflammatory 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.

Device Story

Restoration® Modular System is a modular hip prosthesis consisting of proximal body styles and distal stem designs; components are assembled by surgeons in the operating room or in situ using a locking bolt. System allows independent sizing of proximal body and distal stem to optimize fit for individual patient anatomy. Device is press-fit into the proximal femur. Intended for use by orthopedic surgeons in clinical settings for total hip arthroplasty. Output is a mechanical hip joint replacement; assists in restoring joint function and mobility for patients with degenerative disease, fractures, or failed prior implants.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design and mechanical testing.

Technological Characteristics

Modular hip prosthesis system comprising proximal bodies and distal stems. Components are assembled via a locking bolt. Materials, design, and manufacturing methods are consistent with previously cleared Restoration® Modular System components. Intended for press-fit fixation in the proximal femur.

Indications for Use

Indicated for patients requiring primary or revision total hip arthroplasty, including those with severe proximal bone loss. Specific conditions include non-inflammatory degenerative joint disease (osteoarthritis, avascular necrosis), rheumatoid arthritis, functional deformity, failed prior treatments, and nonunion or fractures of the proximal femur with head involvement.

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.

Submission Summary (Full Text)

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

page lofa

# 510(k) Summary of Safety and Effectiveness for the Modifications to the Restoration® Modular System

K040734

| Proprietary Name: | Restoration® Modular System |
|-------------------|-----------------------------|
|-------------------|-----------------------------|

Femoral Hip Prosthesis Name:

Regulatory Class: Class II

*

### Classification Names and References:

Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis, 21 CFR §888 3353,

Prosthesis, hip, semi-constrained, metal/polymer, uncemented, 21 CFR §888.3350

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

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

Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicumphosphate

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

Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis, 21 CFR 8888 3390

Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis, 21 CFR 8888 3360

Product Codes: 87 LZO, 87 LWJ, 87 JDI, 87 LPH, 87 MEH, 87 KWZ, 87 KWY, and 87 KWL

| Contact Information: | Vivian Kelly, Regulatory Affairs Specialist<br>Howmedica Osteonics Corp.<br>325 Corporate Drive<br>Mahwah, New Jersey 07430<br>Phone: [phone]<br>Fax: [phone] |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared: | July 27, 2004 |

#### Device Description:

The Restoration® Modular Hip System is a modular hip system comprise of different proximal body styles and three distal stem designs, which are affixed with the use of a locking bolt. These individual components are assembled by the surgeon in the operating room or in situ to allow independent sizing of the proximal body and distal stem to better fit the patient. This submission modifies the existing 19mm Cone Body

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

K040734
page 2 of 2

and adds a new style of proximal body called the MT3 body for use with the previously cleared distal stem components

#### Intended Use:

The Restoration® Modular System is intended for for primary or revision total hip arthroplasty, as well as in the presence of severe proximal bone loss. These femoral stems are designed to be press fit into the proximal femur. Examples of specific stoms are designed to the Restoration® Modular System include, non-inflammatory muroutions for aos of the result including osteoarthritis and avascular necrosis, rheumatoid arthritis, correction of functional deformity, revision procedures where other arminis, corroction of have failed, and treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

## Substantial Equivalence:

The features of the new components are substantially equivalent to the predicate I he reatures of the no no arities in intended use, materials and design. Mechanical ucvices based on similaries in lievivalence of the new components to the predicate devices in regards to mechanical strength. In addition, the intended use, material, manufacturing methods, packaging, and sterilization of the predicate and new components are identical

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

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three horizontal lines representing its wings. The eagle is facing left and is enclosed within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 5 2004

Ms. Vivian Kelly Regulatory Affairs Specialist Stryker Howmedica Osteonics 325 Corporate Drive Mahwah, New Jersey 07430

| Re: K040734 | |
|------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade/Device Name: | Restoration Modular System: Addition of the MT3 body;<br>Modification to the 19mm Cone Body |
| Regulation Number: | 21CFR 888.3353; 21CFR 888.3350; 21 CFR 888.3358; 21 CFR 888.3310;<br>21CFR 888.3390; 21CFR 888.3360 |
| Regulation Name: | Hip joint metal/ceramic/polymer semi-constrained cemented or<br>nonporous uncemented prosthesis; Hip joint metal/polymer semi-<br>constrained cemented prosthesis; Hip joint metal/polymer/metal semi-<br>constrained porous-coated uncemented prosthesis; Hip joint<br>metal/polymer constrained cemented or uncemented prosthesis; Hip joint<br>femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis;<br>and Hip joint femoral (hemi-hip) metallic cemented or uncemented<br>prosthesis |
| Regulatory Class: II | |
| Product Code: LZO, LWJ, JDI, LPH, KWZ, KWY, KWL, MEH | |
| Dated: August 2, 2004 | |

Dear Ms. Kelly:

Received: August 4, 2004

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.

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

Page 2 - Ms. Vivian Kelly

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.

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 its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours

Sincerely yours,

Mark M. Millman

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

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

# Indications for Use

510(k) Number (if known): K040734

Device Name: Restoration® Modular System

Indications For Use:

The Restoration® Modular System is intended for primary or revision total hip arthroplasty, as well as in the presence of severe proximal bone loss. These femoral stems are designed to be press fit into the proximal femur. Examples of specific indications for use of the Restorations Modular System include:

- . Non-inflammatory 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.

Prescription Use AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evantation (ODE)

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

4040734

510(k) Number K0407