MODIFICATION TO: RESTORATION MODULAR SYSTEM

K050138 · Howmedica Osteonics Corp. · JDI · Mar 21, 2005 · Orthopedic

Device Facts

• Record ID: K050138
• Device Name: MODIFICATION TO: RESTORATION MODULAR SYSTEM
• Applicant: Howmedica Osteonics Corp.
• Product Code: JDI · Orthopedic
• Decision Date: Mar 21, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3350
• 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 Restoration® 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 Hip System; modular femoral hip prosthesis. Components: proximal body styles (including new Calcar Body) and distal stem designs; assembled by surgeon in OR or in situ using locking bolt. Allows independent sizing of proximal body and distal stem for patient-specific fit. Designed for press-fit into proximal femur. Used in primary or revision total hip arthroplasty to restore joint function, correct deformity, or treat fractures/bone loss. Benefits: improved anatomical fit; restoration of hip joint stability and mobility.

Clinical Evidence

Bench testing only. No clinical data presented.

Technological Characteristics

Modular femoral hip prosthesis consisting of proximal body and distal stem components. Materials and manufacturing methods are identical to the predicate system. Components are assembled via a locking bolt mechanism. Designed 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, non-inflammatory degenerative joint disease (osteoarthritis, avascular necrosis), rheumatoid arthritis, functional deformity, failed prior procedures, or nonunion/fractures of the proximal femur.

Regulatory Classification

Identification

A hip joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).

Predicate Devices

• Restoration® Modular System (K050138)

Submission Summary (Full Text)

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K050138 (pg 10

Line Extension to the Restoration® Modular Hip System

MAR 2 1 2005

Special 510(k) Premarket Notification

## Special 510(k) Summary of Safety and Effectiveness: Line Extension to the Restoration Modular Hip System

| Proprietary Name: | Restoration® Modular System |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Femoral Hip Prosthesis |
| Proposed Regulatory Class: | Class II |
| Classification: | Hip joint metal/ceramic/polymer semi-constrained cemented or<br>nonporous uncemented prosthesis, 21 CFR §888.3353,<br>Hip joint metal/polymer semi-constrained cemented prosthesis, 2<br>CFR §888.3350<br>Hip joint metal/polymer/metal semi-constrained porous-coated<br>uncemented prosthesis, 21 CFR §888.3358<br>Hip joint metal/polymer constrained cemented or uncemented<br>prosthesis, 21 CFR §888.3310<br>Hip joint femoral (hemi-hip) metal/polymer cemented or<br>uncemented prosthesis, 21 CFR §888.3390<br>Hip joint femoral (hemi-hip) metallic cemented or uncemented<br>prosthesis, 21 CFR §888.3360 |
| Device Product Code: | 87 LZO, 87 LWJ, 87 JDI, 87 LPH, 87 MEH, 87 KWZ, 87 KWY,<br>and 87 KWL |
| For Information contact: | Karen Ariemma<br>Regulatory Affairs Specialist<br>Howmedica Osteonics Corp.<br>325 Corporate Drive<br>Mahwah, NJ 07430<br>Telephone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Date Summary Prepared: | January 19, 2005 |

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K050133

Line Extension to the Restoration® Modular Hip System

Special 510(k) Premarket Notification

## Device Description

The Restoration® Modular Hip System is a modular hip system comprised 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 Restoration® Modular Cone Body to create a new style of proximal body called the Restoration® Modular Calcar Body for use with the previously cleared Restoration® Modular Distal Stem components.

## 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 Restoration 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.

## Substantial Equivalence

The features of the new components are substantially equivalent to the predicate devices based on similarities in intended use, materials and design. Mechanical testing and analysis demonstrates substantial equivalence 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.

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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 features a stylized eagle with three curved lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

MAR 2 1 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Karen Ariemma Regulatory Affairs Specialist Howmedica Osteonics, Corp. 325 Corporate Drive Mahwah. New Jersey 07430

Re: K050138

Trade/Device Name: Restoration® Modular System Regulation Number: 21 CFR 888.3353, 21 CFR 888.3350, 21 CFR 888.3358, 21 CFR 888.3310. 21 CFR 888.3390, and 21 CFR 888.3360 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis; Hip joint metal/polymer semiconstrained cemented prosthesis; Hip joint metal/polymer/metal semiconstrained porous-coated uncemented prosthesis; Hip joint metal/polymer constrained cemented or uncemented prosthesis; Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis; and Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis Regulatory Class: II Product Code: LZO, MEH, JDI, LPH, KWZ, KWY, KWL, LWJ Dated: January 19, 2005 Received: January 21, 2005

Dear Ms. Ariemma:

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.

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Page 2 - Ms. Karen Ariemma

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r hat 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/industry/support/index.html.

Sincerely yours,

Mark A. Millmann

Miriam Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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KOS0138 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

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 Restoration® 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 | X |
|-----------------------------|---|
| (Part 21 CFR 801 Subpart D) | |

AND/OR

| 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 Evaluation (ODE)

(Division Sign-Off)

Division of General Restorative and Neurological Devices

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| 510(k) Number | K050138 |