ZIMMER M/L TAPER HIP PROSTHESIS WITH CALCICOAT CERAMIC COATING

K042337 · Zimmer, Inc. · LPH · Nov 4, 2004 · Orthopedic

Device Facts

• Record ID: K042337
• Device Name: ZIMMER M/L TAPER HIP PROSTHESIS WITH CALCICOAT CERAMIC COATING
• Applicant: Zimmer, Inc.
• Product Code: LPH · Orthopedic
• Decision Date: Nov 4, 2004
• 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

Modular, titanium alloy femoral stem for cementless total hip arthroplasty; replaces proximal human femur. Features flat, collarless, wedge-shaped design with proximal-to-distal mediolateral taper. Surface includes circumferential titanium alloy plasma spray porous coating with added Calcicoat (hydroxyapatite/tricalcium phosphate) ceramic coating to promote bony ingrowth. Implanted by orthopedic surgeons in clinical/OR settings. Provides structural support and fixation for hip joint reconstruction; benefits patients by restoring joint function and reducing pain associated with degenerative or traumatic hip conditions.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Modular titanium alloy femoral stem; cementless fixation; proximal-to-distal mediolateral taper; circumferential titanium alloy plasma spray porous coating; Calcicoat (hydroxyapatite/tricalcium phosphate) ceramic coating. Sterilized using same processes as predicate.

Indications for Use

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

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)

Submission Summary (Full Text)

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# K042337

| K0425537 | |
|-----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| NOV - 4 2004<br>Summary of Safety and Effectiveness | |
| Submitter: | Zimmer, Inc.<br>P.O. Box 708<br>Warsaw, IN 46581-0708 |
| Contact Person: | Dalene Binkley, RAC<br>Associate, Regulatory Affairs<br>Telephone: [phone]<br>Fax: [phone] |
| Date: | August 27, 2004 |
| Trade Name: | Zimmer® M/L Taper Hip Prosthesis with Calcicoat®<br>Ceramic Coating |
| Common Name: | Total Hip Prosthesis |
| Classification Name: | Hip joint metal/polymer/metal semiconstrained<br>porous coated uncemented prosthesis |
| Reference and Product Code: | 21 CFR § 888.3358, LPH |
| Predicate Device: | Zimmer® M/L Taper Hip Prosthesis, manufactured<br>by Zimmer, Inc., K032726, cleared October 22,<br>2003. |
| Device Description: | The Zimmer® M/L Taper Hip Prosthesis with<br>Calcicoat® Ceramic Coating is a modular, titanium<br>alloy femoral stem designed to replace the proximal<br>human femur in total hip arthroplasty. It is flat,<br>collarless, and features a proximal-to-distal taper in<br>the mediolateral (M/L) plane. The wedge-shaped<br>prosthesis is designed for cementless use and is<br>circumferentially porous-coated with titanium alloy<br>plasma spray over the proximal body region.<br>Calcicoat® Ceramic Coating (hydroxyapatite<br>tricalcium phosphate [HA/TCP]) has been added to<br>the porous coating to aid bony ingrowth. |
| Intended Use: | Total hip replacement for the following: severe hip<br>pain and disability due to rheumatoid arthritis,<br>osteoarthritis, traumatic arthritis, polyarthritis, |

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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.

The M/L Taper Hip Prosthesis with Calcicoat * Ceramic Coating is manufactured, packaged, and sterilized using the same materials and processes as the predicate devices. The subject device also has the same intended use and fixation methods as the predicate devices

Performance Data (Nonclinical and/or Clinical):

Comparison to Predicate Device:

Non-Clinical Performance and Conclusions:

Non-clinical testing demonstrated that the M/L Taper Hip Prosthesis with Calcicoat® Ceramic Coating met performance requirements and is as safe and effective as the predicate device.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 4 2004

Ms. Darlene Binkley, RAC Associate, Regulatory Affairs Zimmer, Inc. P.O. Box 708 Warsaw, Indiana 46581-0708

Re: K042337

Trade/Device Name: Zimmer® M/L Taper Hip Prosthesis with Calicoat® Ceramic Coating 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 Dated: October 13, 2004 Received: October 15, 2004

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 practicc 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 - Ms. Darlene Binkley, RAC

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/dsma/dsmamain.html

Sincerely yours,

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

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

#### Device Name:

Zimmer® M/L Taper Hip Prosthesis with Calcicoat® Ceramic Coating

### 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)

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Concurrence of CDRH, Office of Device Evaluation (ONE)

(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices

510(k) Number K042337 Page 1 of 1