ZIMMER CONTINUUM ACETABULAR SYSTEM, ZIMMER TRILOGY IT ACETABULAR SYSTEM

K091508 · Zimmer, Inc. · LPH · Sep 11, 2009 · Orthopedic

Device Facts

• Record ID: K091508
• Device Name: ZIMMER CONTINUUM ACETABULAR SYSTEM, ZIMMER TRILOGY IT ACETABULAR SYSTEM
• Applicant: Zimmer, Inc.
• Product Code: LPH · Orthopedic
• Decision Date: Sep 11, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3358
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Continuum and Trilogy IT Acetabular Systems are indicated for primary or revision surgery for rehabilitating hips damaged as a result of noninflammatory degenerative joint disease (NIDJD) or its composite diagnoses of osteoarthritis, avascular necrosis, protrusio acetabuli, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant. The devices are intended for use either with or without bone cement.

Device Story

Modular acetabular cup system for total hip arthroplasty; replaces damaged hip joint. Components include porous-coated shells, polyethylene liners, and optional Tivanium alloy screws for fixation. Used in primary or revision surgery; implanted by orthopedic surgeons in clinical settings. Provides mechanical stability to hip joint; fixation achieved with or without bone cement. Benefits patients by restoring hip function and mobility in cases of degenerative joint disease.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Modular acetabular system; porous-coated shells; polyethylene liners; Tivanium alloy screws. Fixation: cemented or uncemented. Sterilization: standard processes consistent with predicates.

Indications for Use

Indicated for primary or revision hip surgery in patients with noninflammatory degenerative joint disease (NIDJD), including osteoarthritis, avascular necrosis, protrusio acetabuli, traumatic arthritis, slipped capital epiphysis, fused hip, pelvic fracture, and diastrophic variant.

Regulatory Classification

Identification

A hip joint metal/polymer/metal semi-constrained porous-coated uncemented 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 has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.

Predicate Devices

• Trabecular Metal Acetabular System (K021891)
• Trilogy Acetabular System (K934765)
• Converge Acetabular System (K012739)
• Trilogy Acetabular System Large Head Liner (K002960)
• Trilogy Acetabular System 46mm Large Head Liners (K003478)

Submission Summary (Full Text)

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SEP 1 1 2009

Image /page/0/Picture/1 description: The image shows the logo for Zimmer Biomet. The logo consists of a stylized letter "Z" inside of a circle, with the word "zimmer" written in lowercase letters below the circle. The logo is black and white.

K091508

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

#### Summary of Safety and Effectiveness

Sponsor:

Contact Person:

Date:

Trade Name:

Common Name:

Classification Name and Reference:

Predicate Device:

Zimmer, Inc. P.O. Box 708 Warsaw, IN 46581-0708

Benjamin Curson, CQE RAC Associate Project Manager, Regulatory Affairs Telephone: [phone] Fax: [phone]

May 21, 2009

Continuum™ and Trilogy® Integrated Taper (IT) Acetabular Systems

Total Hip Prosthesis

LPH - Prosthesis, Hip, Semi-constrained, metal/polymer, porous, uncemented; 21 CFR 888.3358

JDI - Prosthesis, Hip, Semi-constrained, metal/polymer, cemented; 21 CFR 888.3350

LZO - Prosthesis, Hip, Semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented; 21 CFR 888.3353

Trabecular Metal Acetabular System, manufactured by Zimmer, Inc. (K021891), Trilogy Acetabular System, manufactured by Zimmer, Inc. (K934765). Converge Acetabular System, manufactured by Zimmer, Inc. (K012739), Trilogy Acetabular System Large Head Liner, manufactured by Zimmer, Inc. (K002960), and Trilogy Acetabular System 46mm Large Head Liners, manufactured by Zimmer, Inc. (K003478)

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Page 2 May 21, 2009

Device Description:

Intended Use:

Comparison to Predicate Device:

Performance Data (Nonclinical and/or Clinical):

K091508

The Continuum and Trilogy IT Acetabular Systems are modular acetabular cup systems intended to replace a hip joint and designed to achieve fixation to bone either with or without bone cement. The systems consist of porous coated shells, a polyethylene liner and optional screws. The shells with screw holes permit the use of Tivanium alloy screws to provide additional fixation and security, particularly in those cases where acetabular bone stock is deficient.

The Continuum and Trilogy IT Acetabular Systems are indicated for primary or revision surgery for rehabilitating hips damaged as a result of noninflammatory degenerative joint disease (NIDJD) or its composite diagnoses of osteoarthritis, avascular necrosis, protrusio acetabuli, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant. The devices are intended for use either with or without bone cement.

The Continuum and Trilogy IT Acetabular Systems are packaged, manufactured, and sterilized using the same materials and processes as their predicates. The subject device also has the same intended use and fixation methods as the predicate device.

Non-Clinical Performance and Conclusions:

Non-Clinical testing demonstrated that the Continuum and Trilogy IT Acetabular Systems met performance requirements and are as safe and effective as their predicates.

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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 consists of a stylized depiction of an eagle or bird-like figure, with three curved lines representing its wings or body. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

SEP 1 1 2009

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

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

Re: K091508

Trade/Device Name: Continuum and Trilogy Integrated Taper Acetabular Systems Regulation Number: 21 CFR 888.3358

Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis

Regulatory Class: II Product Code: LPH, LZO, JDI

Dated: August 11, 2009 .

Received: August 12, 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 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.

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### Page 2 - Mr. Benjamin Curson, CQE, RAC

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/ReportaProblem/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.

Daibare Sneetp

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

Enclosure

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K091508

Traditional 510(k) Premarket Notification

# Indications for Use

510(k) Number (if known):

Device Name:

Continuum and Trilogy Integrated Taper (IT) Acetabular systems

#### Indications for Use:

The Continuum and Trilogy IT Acetabular Systems are indicated for primary or revision surgery for rehabilitating hips damaged as a result of noninflammatory degenerative joint disease (NIDJD) or its composite diagnoses of osteoarthritis, avascular necrosis, protrusio acetabuli, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant. The devices are intended for use either with or without bone cement.

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)

Quta for mxn

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

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510(k) Number KD91508