ZIMMER M/L TAPER HIP PROSTHESIS WITH KINECTIV TECHNOLOGY SYSTEM, MODEL(S) 7848 SERIES( MODULAR NECKS), 7713 SERIES

K071856 · Zimmer, Inc. · KWA · Jul 30, 2007 · Orthopedic

Device Facts

• Record ID: K071856
• Device Name: ZIMMER M/L TAPER HIP PROSTHESIS WITH KINECTIV TECHNOLOGY SYSTEM, MODEL(S) 7848 SERIES( MODULAR NECKS), 7713 SERIES
• Applicant: Zimmer, Inc.
• Product Code: KWA · Orthopedic
• Decision Date: Jul 30, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3330
• Device Class: Class 3
• 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. This femoral stem is for cementless use only.

Device Story

Modular, wedge-shaped femoral stem for total or hemi-hip replacement; features Kinectiv technology allowing modular neck options. Device implanted by surgeons in clinical/OR settings. Modularity enables independent adjustment of leg length and offset; facilitates soft tissue balancing; optimizes hip joint center of rotation; maximizes joint stability across diverse patient anatomies. Stem coated with commercially pure titanium alloy plasma spray for cementless fixation. Output is physical restoration of hip joint function; aids clinical decision-making by providing intraoperative flexibility to address specific anatomical requirements.

Clinical Evidence

Bench testing only. No clinical data presented.

Technological Characteristics

Modular, wedge-shaped femoral stem; material: commercially pure titanium alloy plasma spray coating; cementless fixation; modular neck components for offset/leg length adjustment.

Indications for Use

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

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

• Zimmer® M/L Taper Hip Prosthesis with Modular Neck Technology (K063251)

Submission Summary (Full Text)

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# Summary of Safety and Effectiveness

30 Jul 07

| Submitter: | Zimmer, Inc.<br>P.O. Box 708<br>Warsaw, IN 46581-0708 |
|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Dalene T. Binkley, RAC<br>Senior Associate, Regulatory Affairs<br>Telephone: [phone]<br>Fax: [phone] |
| Date: | July 3, 2007 |
| Trade Name: | Zimmer® M/L Taper Hip Prosthesis with Kinectiv™<br>Technology System |
| Common Name: | Total Hip Prosthesis |
| Classification Name<br>and Reference: | 1. KWA - Hip joint metal/metal semi-constrained<br>with uncemented acetabular shell, 21 CFR § 888.<br>3330<br>2. JDL - Hip joint metal/metal semi-constrained<br>with cemented acetabular shell, 21 CFR § 888. 3320<br>3. LPH - Prosthesis, hip, semi-constrained<br>metal/polymer porous uncemented, 21 CFR § 888.<br>3358<br>4. LWJ - Prosthesis, hip, semi-constrained<br>metal/polymer uncemented, 21 CFR § 888. 3360<br>5. MEH - Prosthesis, hip, semi-constrained<br>uncemented metal polymer, non-porous, calcium<br>phosphate, 21 CFR § 888. 3353 |
| Predicate Device: | Zimmer® M/L Taper Hip Prosthesis with Modular<br>Neck Technology, manufactured by Zimmer, Inc.,<br>K063251, cleared January 24, 2007. |

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| Device Description: | The Zimmer M/L Taper Hip Prosthesis with<br>Kinectiv Technology System is a modular, wedge-<br>shaped stem that is coated with commercially pure<br>titanium alloy plasma spray. |
|---------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The modular neck options allow for soft tissue<br>balancing and easier restoration of the hip joint<br>center of rotation. The modularity feature will<br>allow surgeons to independently equalize leg length<br>and optimize offset while, at the same time,<br>maximizing joint stability for a variety of patient<br>anatomies. |
| Intended Use: | Total hip replacement for the following: severe hip<br>pain and disability due to rheumatoid arthritis,<br>osteoarthritis, traumatic arthritis, polyarthritis,<br>collagen disorders, avascular necrosis of the<br>femoral head, nonunion of previous fractures of the<br>femur; congenital hip dysplasia, protrusio acetabuli,<br>slipped capital femoral epiphysis; disability due to<br>previous fusion; previously failed endoprostheses,<br>and/or total hip components in the affected<br>extremity and acute femoral neck fractures. |
| | Hemi-hip replacement for the following: fracture<br>dislocation of the hip; elderly, debilitated patients<br>when a total hip replacement is contraindicated;<br>irreducible fractures in which adequate fixation<br>cannot be obtained; certain high subcapital fractures<br>and comminuted femoral neck fractures in the aged;<br>nonunion of femoral neck fractures; secondary<br>avascular necrosis of the femoral head; pathological<br>fractures of the femoral neck; and osteoarthritis in<br>which the femoral head is primarily affected. |
| | This femoral stem is for cementless use only. |
| Comparison to Predicate Device: | The Zimmer M/L Taper Hip Prosthesis with Kinetiv<br>Technology System is packaged, manufactured, and<br>sterilized using the same materials and processes as<br>its predicate. The subject device also has the same<br>intended use and fixation methods as the predicate. |

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Performance Data (Nonclinical and/or Clinical):

Non-Clinical Performance and Conclusions:

Non-clinical testing demonstrated that the Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology System met performance requirements and is as safe and effective as its predicate.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Zimmer, Inc. % Ms. Dalene T. Binkley Senior Associate, Corporate Regulatory Affairs P.O. Box 708 Warsaw, Indiana 46581-0708

> K071856 Trade/Device Name: Zimmer® M/L Taper Hip Prosthesis with Kinectiv® Technology System 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, JDL, LPH, LWJ, MEH Dated: July 3. 2007 Received: July 5, 2007

JUL 3 0 2007

Dear Ms. Binkley:

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

Image /page/3/Picture/9 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's emblem in the center. The emblem consists of a stylized caduceus-like symbol with three intertwined strands, representing health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the emblem in a circular fashion.

Re:

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Page 2 - Ms. Dalene T. Binkley

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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 the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Barbara BruchuP

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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cc: HFZ-401 DMC HFZ-404 510(k) Staff HFZ-410 DGRND D.O. f/t:JSG:afb:7/30/07 OC Numbers: Division of Enforcement A 240-276-0115 Dental, ENT and Ophthalmic Devices Branch 240-276-0115 OB/GYN, Gastro. & Urology Devices Branch 240-276-0115 General Hospital Devices Branch 240-276-0115 General Surgery Devices Branch 240-276-0115 Division of Enforcement B 240-276-0120 Cardiovascular & Neurological Devices Branch 240-276-0120 Orthopedic, Physical Medicine & Anesthesiology Devices and Radiological 240-276-0120 Devices

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071856

## Indications for Use

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

Device Name:

Zimmer® M/L Taper Hip Prosthesis with Kinectiv™ Technology System

#### 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.

This femoral stem is for cementless use only.

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)

Barbara Medium for MAM

Division of Ge Restorati and Neurological Devices

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510(k) Number K071856

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