RESTORATION ADM SYSTEM

K072020 · Howmedica Osteonics Corp. · MEH · Oct 18, 2007 · Orthopedic

Device Facts

• Record ID: K072020
• Device Name: RESTORATION ADM SYSTEM
• Applicant: Howmedica Osteonics Corp.
• Product Code: MEH · Orthopedic
• Decision Date: Oct 18, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3353
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Restoration™ ADM 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 only with any currently available Howmedica Osteonics 22.2 and 28 mm diameter femoral heads.

Device Story

Restoration™ ADM System is a dual-mobility acetabular hip replacement component. System comprises a polished metal acetabular cup and a polyethylene insert. Insert retains a femoral head and articulates against the inner surface of the cup, functioning as a bipolar head to provide two articulating surfaces. Cup features an anatomically shaped rim to minimize impingement with the stem or psoas muscle. Device is intended for primary and revision total hip arthroplasty to alleviate pain and restore function. Used in surgical settings by orthopedic surgeons. Benefits include improved stability and reduced dislocation risk for patients undergoing hip arthroplasty.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design, material, and operational principle comparisons to predicate devices.

Technological Characteristics

Acetabular cup manufactured from wrought Cobalt Chromium alloy with Commercially Pure Titanium and Hydroxylapatite coating. Dual-mobility design features a polyethylene insert articulating within a polished metal cup. Intended for cementless fixation. 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, revision of failed treatments, or nonunion/fractures of the proximal femur with head involvement. Also indicated for patients with dislocation risks. 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

• Trident® Acetabular System
• Biomet Tri-Polar System
• Plus Orthopaedics Ag Polarcup Dual Mobility System
• UHR Bipolar System

Submission Summary (Full Text)

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## 1072020

OCT 1 8 2007

## 510(k) Summary of Safety and Effectiveness

| Proprietary Name: | Restoration™ ADM System |
|------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Artificial Hip Replacement Components - Acetabular |
| Classification Name and Reference: | Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis, 21 CFR §888.3353 |
| Proposed Regulatory Class: | Class II |
| Product Codes: | 87 MEH - prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calcium- phosphate |
| For Information contact: | Karen Ariemma Senior Regulatory Affairs Specialist Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 Phone: [phone] Fax: [phone] |
| Date Prepared: | October 17, 2007 |

Description:

The Restoration™ Anatomic Dual Mobility (ADM) System consists of an acetabular cup and an acetabular insert. The Restoration™ ADM insert retains a femoral head. The outer diameter of the insert articulates on the inner surface of the polished metal acetabular cup. The polyethylene insert therefore functions as a bipolar head as there are two articulating surfaces.

The Restoration™ ADM Acetabular Cup has a highly polished inner surface to help reduce wear between the cup and the insert and an anatomical shaped rim to limit cup impingement with the stem or the psoas muscle. The Restoration™ ADM Acetabular Cup is manufactured from wrought Cobalt Chromium alloy with a Commercially Pure Titanium and Hydroxylapatite coating.

Intended Use

The Restoration™ ADM 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

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intended to be used only with any currently available Howmedica Osteonics 22.2 and 28 mm diameter femoral heads.

## Indications:

The indications for use of total hip replacement prostheses include:

- Noninflammatory degenerative joint disease including osteoarthritis and avascular 1) necrosis:
- Rheumatoid arthritis; 2)
- 3) Correction of functional deformity;
- Revision procedures where other treatments or devices have failed; 4)
- Treatment of nonunion, femoral neck and trochanteric fractures of the proximal ર) femur with head involvement that are unmanageable using other techniques.
- 6) Dislocation risks

This acetabular cup is intended for cementless use only.

Substantial Equivalence:

The Restoration™ ADM Acetabular System is substantially equivalent to other commercially available acetabular systems in regards to intended use, design, materials, and operational principles. The following devices are examples of predicate systems: Trident® Acetabular System, Biomet Tri-Polar System, Plus Orthopaedics Ag Polarcup Dual Mobility System -and UHR Bipolar System.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" are arranged in a circular pattern around the eagle. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## OCT 1 8 2007

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

Re: K072020

Trade/Device Name: Restoration Anatomic™ Dual Mobility (ADM) System 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(s): MEH, LZO Dated: July 20, 2007 Received: July 23, 2007

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.

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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic

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Page 2 - Ms. Karen Ariemma

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 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 yours.

Sincerely, yours,

Clarlara Buchn

Mark N. Melkerson 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): K072020

Device Name: Restoration™ ADM System

Indications for Use:

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

- Noninflammatory degenerative joint disease including osteoarthritis and avascular 1) necrosis;
- Rheumatoid arthritis 2)
- 3) Correction of functional deformity;
- Revision procedures where other treatments or devices have failed; 4)
- Treatment of nonunion, femoral neck and trochanteric fractures of the proximal 2) femur with head involvement that are unmanageable using other techniques.
- 6) Dislocation risks

This acetabular cup 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)

Solace Buetm

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

510(k) Number_