LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE ELEVATED LINERS

K093846 · Zimmer, Inc. · LZO · Feb 4, 2010 · Orthopedic

Device Facts

• Record ID: K093846
• Device Name: LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE ELEVATED LINERS
• Applicant: Zimmer, Inc.
• Product Code: LZO · Orthopedic
• Decision Date: Feb 4, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3353
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Longevity IT Highly Crosslinked Polyethylene Elevated Liners are intended to be used with either Continuum or Trilogy IT Acetabular components in Total Hip Arthroplasty. The liners are available in 22, 28, 32 and 36mm articulation diameters. The system is indicated for primary or revision surgery in skeletally mature individuals 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 system is intended for use either with or without bone cement in total hip arthroplasty.

Device Story

Longevity IT Highly Crosslinked Polyethylene Elevated Liners function as acetabular components in total hip arthroplasty; used with Continuum or Trilogy IT Acetabular systems. Device provides articulating surface for hip joint; available in 22, 28, 32, and 36mm diameters. Used in surgical settings by orthopedic surgeons; implanted during primary or revision hip replacement procedures. Device acts as bearing surface to restore hip function in patients with degenerative joint disease. Manufactured using same materials and processes as predicate devices; intended for use with or without bone cement.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Highly crosslinked polyethylene liners; available in 22, 28, 32, and 36mm articulation diameters. Designed for use with Continuum or Trilogy IT Acetabular components. Compatible with cemented or uncemented fixation. No software or electronic components.

Indications for Use

Indicated for primary or revision total hip arthroplasty in skeletally mature individuals 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/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

• Continuum™ and Trilogy® Integrated Taper (IT) Acetabular Systems (K091508)

Submission Summary (Full Text)

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Image /page/0/Picture/0 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.

093846

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

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# FEB - 4 2010

## 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]

December 14, 2009

Longevity® IT Highly Crosslinked Polyethylene Elevated Liners

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.

Continuum™ and Trilogy® Integrated Taper (IT) Acetabular Systems, manufactured by Zimmer Inc., K091508, cleared September 11, 2009.

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Device Description:

Intended Use:

Comparison to Predicate Device:

Performance Data (Nonclinical and/or Clinical):

The Longevity IT Highly Crosslinked Polyethylene Elevated Liners are intended to be used with either Continuum or Trilogy IT Acetabular components in Total Hip Arthroplasty. The liners are available in 22, 28, 32 and 36mm articulation diameters.

The system is indicated for primary or revision surgery in skeletally mature individuals 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 system is intended for use either with or without bone cement in total hip arthroplasty.

The Longevity IT Highly Crosslinked Polyethylene Elevated Liners are packaged, manufactured, and sterilized using the same materials and processes as their predicates. The subject device also has the same intended use as the predicate.

Non-Clinical Performance and Conclusions:

Non-Clinical testing demonstrated that the Longevity IT Highly Crosslinked Polyethylene Elevated Liners met performance requirements and are as safe and effective as their predicate.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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

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

FEB - 4 2010

#### Re: K093846

Trade/Device Name: Longevity® IT Highly Crosslinked Polyethylene Elevated Liners Regulation Number: 21 CFR 888.3353

Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis

Regulatory Class: II

Product Code: LZO, JDI, LPH Dated: January 19, 2010 Received: January 21, 2010

#### 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 1

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### Page 2 - Mr. Benjamin Curson'

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 yours,

Aabaue Breenm

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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K093846 Indications for Use

#### 510(k) Number (if known):

#### Device Name:

Longevity® IT Highly Crosslinked Polyethylene Elevated Liners

#### Indications for Use:

The system is indicated for primary or revision surgery in skeletally mature individuals 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 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 (ODE)

Omita for mkn

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

510(k) Number K093846

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