SERIES II CONSTRAINED ACETABULAR LINERS

K063552 · Howmedica Osteonics Corp. · KWZ · Mar 8, 2007 · Orthopedic

Device Facts

• Record ID: K063552
• Device Name: SERIES II CONSTRAINED ACETABULAR LINERS
• Applicant: Howmedica Osteonics Corp.
• Product Code: KWZ · Orthopedic
• Decision Date: Mar 8, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3310
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Series II Constrained Acetabular Liners are intended to be used with the various components of the Series II Hip System in the replacement of the acetabulum and femoral head bearing surface secondary to degenerative joint disease, trauma, or failed previous prosthesis. These constrained liner components provide the surgeon with an alternative method in treating the total hip replacement patient who chronically dislocates.

Device Story

Series II Constrained Acetabular Liners function as components of total hip prosthesis system; designed for revision patients at high risk of dislocation. Device provides mechanical constraint to prevent femoral head disarticulation from acetabular component. Used by orthopedic surgeons in clinical/hospital settings during total hip replacement procedures. Benefits include stabilization of hip joint in patients with chronic dislocation history or instability. Device integrates with existing Series II Hip System components.

Clinical Evidence

No clinical data provided; substantial equivalence based on mechanical property comparisons.

Technological Characteristics

Metal/polymer constrained acetabular liner; component of total hip prosthesis system. Designed for cemented or uncemented use. Mechanical constraint mechanism.

Indications for Use

Indicated for revision total hip prosthesis patients at high risk of dislocation due to history of prior dislocation, bone loss, joint/soft tissue laxity, neuromuscular disease, or intraoperative instability.

Regulatory Classification

Identification

A hip joint metal/polymer constrained cemented or uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device prevents dislocation in more than one anatomic plane and has components that are linked together. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular component made of ultra-high-molecular-weight polyethylene with or without a metal shell, made of alloys, such as cobalt-chromium-molybdenum and titanium alloys. This generic type of device is intended for use with or without bone cement (§ 888.3027).

Special Controls

*Classification.* Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Hip Joint Metal/Polymer Constrained Cemented or Uncemented Prosthesis.”

Submission Summary (Full Text)

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K063552 (pg 1 of 2)

# Summary of Safety and Effectiveness Series II Constrained Acetabular Liners

| Proprietary Name: | Series II Constrained Acetabular Liners |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Artificial Hip Acetabular Component |
| Classification Name and Reference | Hip joint metal/polymer constrained<br>cemented or uncemented prosthesis,<br>21 CFR §888.3310 |
| Device Product Code: | 87 KWZ |
| For Information contact: | Francisco Haro, Regulatory Affairs Specialist<br>Howmedica Osteonics Corp.<br>325 Corporate Drive<br>Mahwah, NJ 07430<br>Phone: [phone]<br>Fax: [phone] |
| Date Summary Prepared: | November 21, 2006 |

# Description:

This 510(k) submission is a line extension intended to add Series II Constrained Acetabular Liners to the Series II Hip System.

# Intended Use:

The Series II Constrained Acetabular Liners are intended to be used with the various components of the Series II Hip System in the replacement of the acetabulum and femoral head bearing surface secondary to degenerative joint disease, trauma, or failed previous prosthesis. These constrained liner components provide the surgeon with an alternative method in treating the total hip replacement patient who chronically dislocates.

#### Indications for Use:

A Constrained Acetabular Insert is intended for use as a component of a total hip prosthesis in revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intraoperative instability.

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K063552 (pg2 of 2)

# Substantial Equivalence:

The subject Series II Constrained Acetabular Liners share intended use, design concepts, and demonstrated comparable mechanical properties to the predicate components and are substantially equivalent to these devices.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Howmedica Osteonics Corporation c/o Mr. Francisco Haro Regulatory Affairs Specialist 325 Corporate Drive Mahwah, New Jersey 07430

MAR 0 8 2007

Re: K063552

Trade/Device Name: Series II Constrained Acetabular Liners Regulation Number: 21 CFR 888.3310 Regulation Name: Hip joint metal/polymer constrained cemented or uncemented prosthesis Regulatory Class: Class II Product Code: KWZ Dated: February 16, 2007 Received: February 20, 2007

Dear Mr. Haro:

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 - Mr. Francisco Haro

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,

Sincerely yours,

Mark A. Milliman

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): \/ 063552

Device Name: Series II Constrained Acetabular Liners

Indications for Use:

A Constrained Acetabular Insert is intended for use as a component of a total hip prosthesis in revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intraoperative instability.

Over-The-Counter Use Prescription Use _ X 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 (ODE)

Mark A. Millman

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

510(k) Number K063552