METASUL TAPER LINERS, METASUL FEMORAL HEADS

K091973 · Zimmer GmbH · KWA · Nov 17, 2009 · Orthopedic

Device Facts

• Record ID: K091973
• Device Name: METASUL TAPER LINERS, METASUL FEMORAL HEADS
• Applicant: Zimmer GmbH
• Product Code: KWA · Orthopedic
• Decision Date: Nov 17, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3330
• Device Class: Class 3
• Attributes: Therapeutic

Intended Use

Noninflammatory degenerative joint disease (NIDJD) including avascular necrosis, osteoarthritis, post-traumatic arthritis and congenital hip dysplasia and inflammatory joint disease (IJD), e.g. rheumatoid arthritis if bone quality is adequate. Failed previous surgery where pain, deformity, or dysfunction persists. Revision of previously failed hip arthroplasty. Total hip replacements may be considered for younger patients if any unequivocal indication outweighs the risks associated with the age of the patient and modified demands regarding activity and hip joint loading are assured. This includes severely handicapped patients with multiple joint involvement, for whom an immediate need of hip mobility leads to an expectation of significant improvement in the quality of their lives. The system is intended for use either with or without bone cement in total hip arthroplasty.

Device Story

Metasul Taper Liners and Femoral Heads are orthopedic components for total hip arthroplasty. Fabricated from CoCrMo alloy; liner features machined locking taper to mate with Continuum and Trilogy IT acetabular shells. Designed for use exclusively with Metasul Femoral Heads. Implanted by orthopedic surgeons in clinical settings; used with or without bone cement. Device restores hip joint function by replacing damaged articular surfaces; provides mechanical articulation to reduce pain and improve mobility in patients with degenerative or inflammatory joint disease.

Clinical Evidence

Clinical data demonstrates the safety and effectiveness of the subject device.

Technological Characteristics

Materials: CoCrMo alloy. Design: Acetabular liner with machined locking taper for integration with specific acetabular shells (Continuum/Trilogy IT). Energy source: None (mechanical). Connectivity: None. Sterilization: Not specified.

Indications for Use

Indicated for patients with noninflammatory degenerative joint disease (avascular necrosis, osteoarthritis, post-traumatic arthritis, congenital hip dysplasia), inflammatory joint disease (e.g., rheumatoid arthritis with adequate bone quality), failed previous surgery, or revision of failed hip arthroplasty. Applicable to younger patients if clinical indications outweigh age-related risks and activity demands are managed; also for severely handicapped patients requiring improved mobility.

Regulatory Classification

Identification

A hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis is a two-part 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 consist of a femoral and an acetabular component, both made of alloys, such as cobalt-chromium-molybdenum. The femoral component is intended to be fixed with bone cement. The acetabular component is intended for use without bone cement (§ 888.3027).

Predicate Devices

• Inter-Op™ Metasul Acetabular System (K974728)
• Epsilon™ Metasul Acetabular 32mm Insert/Femoral Head (K033634)
• Depuy Pinnacle Metal-on-Metal Acetabular Cup Liners (K062426)

Submission Summary (Full Text)

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

K091973

Image /page/0/Picture/1 description: The image shows the logo for Zimmer. The logo consists of a circle with a stylized letter Z inside it. Below the circle, the word "zimmer" is written in a sans-serif font.

P.O. Box 708 Warsaw, IN 46581-0708 574 267-6131

## Summary of Safety and Effectiveness

NOV 1 7 2009 Zimmer, GmbH Sponsor: Sulzer Allee 8 Winterthur, CH-8404, Switzerland Benjamin Curson, CQE RAC Contact Person: Associate Project Manager, Regulatory Affairs Telephone: [phone] Fax: [phone] June 29, 2009 Date: Metasul® Taper Liner and Metasul Femoral Heads Trade Name: Total Hip Prosthesis Common Name: Classification Name KWA - Hip joint metal/metal semi-constrained with uncemented acetabular shell. 21 CFR § 888.3330 Classification Reference: Inter-Op™ Metasul Acetabular System (K974728),
Epsilon™ Metasul Acetabular 32mm Predicate Device: Insert/Femoral Head (K033634), both manufactured by Zimmer, and Depuy Pinnacle Metal-on-Metal Acetabular Cup Liners (K062426), manufactured by Depuy Orthopedics The Metasul Taper Liner and Femoral Heads are Device Description: composed of CoCrMo alloy. The outer diameter of the liner is machined with a locking taper feature that mates with the interior Continuum™ and Trilogy® IT acetabular shell's taper. The Metasul Taper Liners are designed for use only with Metasul Femoral Heads.

Page 1 of 2

ા ર

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

K091973

Page 2 June 29, 2009

Noninflammatory degenerative joint disease Intended Use: (NIDJD) including avascular necrosis, osteoarthritis, post-traumatic arthritis and congenital hip dysplasia and inflammatory joint disease (IJD), e.g. rheumatoid arthritis if bone quality is adequate. Failed previous surgery where pain, deformity, or dysfunction persists. Revision of previously failed hip arthroplasty. Total hip replacements may be considered for vounger patients if any unequivocal indication outweighs the risks associated with the age of the patient and modified demands regarding activity and hip joint loading are assured. This includes severely handicapped patients with multiple joint involvement, for whom an immediate need of hip mobility leads to an expectation of significant improvement in the quality of their lives. The system is intended for use either with or without bone cement in total hip arthroplasty. The Metasul Taper Liners and Metasul Femoral Comparison to Predicate Device: Heads have the same intended use as the predicate devices. The design features and materials of the subject device are substantially equivalent to the predicate devices. Non-Clinical Performance and Conclusions: Performance Data (Nonclinical and/or Clinical): Non-Clinical testing demonstrated that the Metasul Taper liners and Metasul Femoral Heads met performance requirements and are as safe and effective as their predicates.

Clinical Performance and Conclusions:

Clinical data demonstrates the safety and effectiveness of the subject device.

Page 2 of 2

ાર્ ર

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

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized emblem featuring three abstract human profiles facing to the right, resembling a family or group of people.

## Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

Zimmer, GmbH % Zimmer, Inc. Mr. Benjamin Curson, COE RAC Associate Project Manager Regulatory Affairs P.O. Box 708 Warsaw, Indiana 46581-0708

NOV 17 2009

Re: K091973

Trade/Device Name: Metasul® Taper Liners, Metasul Femoral Heads Regulation Number: 21 CFR 888.3330 Regulation Name: Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis Regulatory Class: Class III Product Code: KWA Dated: October 20, 2009 Received: October 21, 2009

Dear Mr. Curson:

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 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

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

Page 2 - Mr. Benjamin Curson, CQE RAC

comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Jonita D

Image /page/3/Picture/7 description: The image shows a handwritten symbol that appears to be a combination of the letters 'g' and 'n'. The 'g' is written in a cursive style, with a loop at the top and a curved tail extending downwards. The 'n' is connected to the top of the 'g', forming a single, stylized character. The symbol is drawn in black ink on a white background.

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

Image /page/4/Picture/0 description: The image shows the logo for Zimmer. The logo consists of a circle with a stylized "Z" inside of it, followed by the word "zimmer" in a bold, sans-serif font. The logo is black and white.

Traditional 510(k) Premarket Notification

## Indications for Use

510(k) Number (if known):

Device Name:

Metasul® Taper Liners and Metasul Femoral Heads

## Indications for Use:

- Noninflammatory degenerative joint disease (NIDJD) including avascular necrosis, . osteoarthritis, post-traumatic arthritis and congenital hip dysplasia and inflammatory joint disease (IJD), e.g. rheumatoid arthritis if bone quality is adequate.
- Failed previous surgery where pain, deformity, or dysfunction persists. .
- . Revision of previously failed hip arthroplasty.
- . Total hip replacements may be considered for younger patients if any unequivocal indication outweighs the risks associated with the age of the patient and modified demands regarding activity and hip joint loading are assured. This includes severely handicapped patients with multiple joint involvement, for whom an immediate need of hip mobility leads to an expectation of significant improvement in the quality of their lives.
- The system is intended for use either with or without bone cement in total hip . arthroplasty.

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 (ÓDE)

Onetu for mxn

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

K091973 510(k) Number _

Page 1 of 1