ZIMMER M/L TAPER HIP PROSTHESIS

K060040 · Zimmer, Inc. · LPH · May 12, 2006 · Orthopedic

Device Facts

• Record ID: K060040
• Device Name: ZIMMER M/L TAPER HIP PROSTHESIS
• Applicant: Zimmer, Inc.
• Product Code: LPH · Orthopedic
• Decision Date: May 12, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3358
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Total hip replacement for the following: severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, nonunion of previous fractures of the femur; congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis; disability due to previous fusion; previously failed endoprostheses, and/or total hip components in the affected extremity and acute femoral neck fractures. Hemi-hip replacement for the following: fracture dislocation of the hip; elderly, debilitated patients when a total hip replacement is contraindicated; irreducible fractures in which adequate fixation cannot be obtained; certain high subcapital fractures and comminuted femoral neck fractures in the aged; nonunion of femoral neck fractures; secondary avascular necrosis of the femoral head; pathological fractures of the femoral neck; and osteoarthritis in which the femoral head is primarily affected.

Device Story

Zimmer M/L Taper Hip Prosthesis is a modular, collarless femoral stem featuring a proximal-to-distal mediolateral taper. Designed for total or hemi-hip replacement surgery; implanted by orthopedic surgeons in clinical settings. Device components include titanium alloy plasma spray coating on the proximal body; optional Calcicoat Ceramic Coating. System provides standard and extended offset options; current submission adds new size and neck length options to the previously cleared system. Device functions as a mechanical hip joint replacement; restores joint mobility and reduces pain in patients with degenerative or traumatic hip conditions.

Clinical Evidence

No clinical data was required or provided for this device; substantial equivalence was determined based on non-clinical performance analysis.

Technological Characteristics

Modular femoral stem; titanium alloy plasma spray coating; optional Calcicoat Ceramic Coating. Design features proximal-to-distal taper in mediolateral plane. Collarless geometry. Available in standard and extended offset options.

Indications for Use

Indicated for patients requiring total or hemi-hip replacement due to severe pain/disability from arthritis (rheumatoid, osteoarthritis, traumatic, polyarthritis), collagen disorders, avascular necrosis, femoral fracture nonunion, congenital dysplasia, protrusio acetabuli, slipped capital femoral epiphysis, previous fusion, failed endoprostheses, or acute femoral neck fractures. Hemi-hip replacement indicated for fracture dislocation, elderly/debilitated patients where total replacement is contraindicated, irreducible fractures, high subcapital/comminuted femoral neck fractures, or pathological fractures.

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

• Zimmer® M/L Taper Hip Prosthesis (K032726)
• Zimmer M/L Taper Hip Prosthesis with Calcicoat® Ceramic Coating (K042337)
• Zimmer CPT® 12/14 (K030265)
• Zimmer VerSys® Beaded Mid-Coat Stem (K973714)

Submission Summary (Full Text)

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K060040 (pg 1 of 2)

#### Summary of Safety and Effectiveness

MAY 12 2006

Contact Person:

Date:

Trade Name:

Common Name:

Classification Names and References:

Predicate Devices:

Device Description:

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

Karen Cain, RAC Manager, Corporate Regulatory Affairs Telephone: [phone] Fax: [phone]

January 5, 2006

Zimmer® M/L Taper Hip Prosthesis

Total Hip Prosthesis

Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis 21 CFR § 888.3358, product code LPH

Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis 21 CFR § 888.3353, product codes MEH, LZO

Zimmer® M/L Taper Hip Prosthesis, K032726, cleared October 22, 2003

Zimmer M/L Taper Hip Prosthesis with Calcicoat® Ceramic Coating, K042337, cleared November 4, 2004

Zimmer CPT® 12/14, K030265, cleared March 4, 2003

Zimmer VerSys® Beaded Mid-Coat Stem, K973714, cleared December 24, 1997

The Zimmer M/L Taper Hip Prostheses are flat, collarless, modular femoral stems with a proximal to distal taper in the mediolateral plane. The

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prostheses are circumferentially coated with titanium alloy plasma spray over the proximal body region and are available in standard and extended offset options, with or without Calcicoat Ceramic Coating.

Total hip replacement for the following: severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, nonunion of previous fractures of the femur; congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis; disability due to previous fusion; previously failed endoprostheses, and/or total hip components in the affected extremity and acute femoral neck fractures.

Hemi-hip replacement for the following: fracture dislocation of the hip; elderly, debilitated patients when a total hip replacement is contraindicated; irreducible fractures in which adequate fixation cannot be obtained; certain high subcapital fractures and comminuted femoral neck fractures in the aged; nonunion of femoral neck fractures; secondary avascular necrosis of the femoral head: pathological fractures of the femoral neck; and osteoarthritis in which the femoral head is primarily affected.

An additional size option and an additional neck length option are being added to the previously cleared Zimmer M/L Taper Hip Prosthesis system.

Non-Clinical Performance and Conclusions:

Analysis of the modified devices indicates that they are substantially equivalent to the predicates.

Clinical Performance and Conclusions:

Clinical data and conclusions were not needed for this device.

#### Intended Use:

Comparison to Predicate Device:

Performance Data (Nonclinical and/or Clinical):

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo consists of a stylized caduceus, a symbol often associated with medicine and healthcare, with three parallel lines forming the wings and a base that resembles flowing water. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus, with the words evenly spaced to follow the curve of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 2 2006

Zimmer, Inc. c/o Ms. Karen Cain Manager, Corporate Regulatory Affairs P.O. Box 708 -Warsaw, Indiana 46581-0708

Re: K060040

Trade/Device Name: Zimmer® M/L Taper Hip Prosthesis Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: Class II Product Code: LPH, MEH, LZO Dated: April 13, 2006

Received: April 14, 2006

Dear Ms. Cain:

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

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### Page 2 - Ms. Karen Cain

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. 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,

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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K060040

## Indications for Use

510(k) Number (if known):

Device Name:

Zimmer® M/L Taper Hip Prosthesis

Indications for Use:

Total hip replacement for the following: severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, nonunion of previous fractures of the femur; congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis; disability due to previous fusion; previously failed endoprostheses, and/or total hip components in the affected extremity and acute femoral neck fractures.

Hemi-hip replacement for the following: fracture dislocation of the hip; elderly, debilitated patients when a total hip replacement is contraindicated; irreducible fractures in which adequate fixation cannot be obtained; certain high subcapital fractures and comminuted femoral neck fractures in the aged; nonunion of femoral neck fractures; secondary avascular necrosis of the femoral head; pathological fractures of the femoral neck; and osteoarthritis in which the femoral head is primarily affected.

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)

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KOSOD40 ***(k) Number

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