ZMR HIP SYSTEM-POROUS REVISION

K994286 · Zimmer, Inc. · LPH · Mar 10, 2000 · Orthopedic

Device Facts

• Record ID: K994286
• Device Name: ZMR HIP SYSTEM-POROUS REVISION
• Applicant: Zimmer, Inc.
• Product Code: LPH · Orthopedic
• Decision Date: Mar 10, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3358
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ZMR Porous Revision Hip Prosthesis is intended for revision hip arthroplasty in patients whose bone stock is of poor quality or inadequate for other reconstruction techniques as indicated by deficiencies of the femoral head, neck, or portions of the proximal femur.

Device Story

ZMR Porous Revision Hip Prosthesis is a modular femoral stem for cementless revision hip arthroplasty. Device consists of three intraoperatively assembled components: proximal body, distal stem, and compression nut. Manufactured from Tivanium (Ti-6Al-4V) alloy. Features modular head/neck and midstem junctions. Used by orthopedic surgeons in clinical settings to replace failed hip components or address femoral bone stock deficiencies. Provides structural support for hip joint reconstruction; articulates with acetabular components via Morse-type neck taper. Benefits patients by restoring hip function in revision cases where bone quality is compromised.

Clinical Evidence

No clinical data provided. Substantial equivalence based on design, material, and intended use comparisons to legally marketed predicate devices.

Technological Characteristics

Femoral hip prosthesis; modular design (proximal body, distal stem, compression nut). Material: Tivanium (Ti-6Al-4V) alloy. Fixation: Cementless/porous-coated. Interface: Morse-type proximal neck taper. Intended for intramedullary canal placement.

Indications for Use

Indicated for cementless revision hip arthroplasty in patients with poor or inadequate bone stock due to deficiencies of the femoral head, neck, or proximal femur, where conservative treatment has failed or progressive disability exists.

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

• Impact Modular Total Hip System (K921274)
• Coated ZT Proximal Sleeve of the S-ROM Total Hip System (K934412)
• Mallory-Head Modular Porous Series (K921274)
• ZMR Hip System-Revision Taper (K992667)

Submission Summary (Full Text)

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MAH 1 0 2000

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<994286

P.O. Box 708 Warsaw, IN 46581-0708 219 267-6131

219 207-6131

## Summary of Safety and Effectiveness

### Submitted By: .

Zimmer, Inc. P.O. Box 708 Warsaw, Indiana 46581-0708 219-267-6131

### ● Contact Person:

Karen Cain Senior Regulatory Affairs Associate Telephone: [phone] Fax: [phone]

- . Date:
December 17, 1999

- . Trade Name:
ZMR™ Hip System-Porous Revision

- . Common Name:
Femoral Hip Prosthesis

- . Classification Name:
Hip joint metal/polymer semiconstrained uncemented prosthesis

- . Predicate Devices:
- Impact™ Modular Total Hip System, manufactured by Biomet, K921274, . cleared February 15, 1994
- Coated ZT™ Proximal Sleeve of the S-ROM™ Total Hip System, . manufactured by Johnson & Johnson (previously Joint Medical Products Corporation), K934412, cleared June 3, 1994
- Mallory-Head Modular Porous Series, manufactured by Biomet, K921274, . cleared February 15, 1994

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/c 994286

Py 215

## Summary of Safety and Effectiveness (Continued)

- ZMR™ Hip System-Revision Taper, manufactured by Zimmer, K992667, cleared October 27, 1999
### Device Description

The ZMR Porous Revision Hip Prosthesis is a femoral stem manufactured from Tivanium® (Ti-6Al-4V) Alloy and intended for cementless use in revision hip arthroplasty. This device has two modular junctions: a head/neck junction and a midstem junction. Three components are intraoperatively assembled to construct the device: a proximal segment or "body," a distal stem, and a compression nut.

#### . Intended Use

The ZMR Porous Revision Hip Prosthesis is intended for revision hip arthroplasty in patients whose bone stock is of poor quality or inadequate for other reconstruction techniques as indicated by deficiencies of the femoral head, neck, or portions of the proximal femur.

#### . Comparison to Predicate Devices

All hip systems listed above are substantially equivalent to each other and the ZMR Porous Revision Hip Prosthesis in that each is intended for cementless fixation into the intramedullary canal for pathological or degenerative conditions involving the femur and/or acetabulum. All predicate devices feature a Morse-type proximal neck taper that mates with a femoral head which, in turn, articulates upon the ultra-high molecular-weight polyethylene (UHMWPE) bearing surface of a total hip or hemihip acetabular component. All predicate devices are manufactured from metal alloys that have a history of successful clinical use in orthopaedic applications.

RA11901K.510

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and head. The eagle is positioned inside a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is written around the upper half of the circle. The text is in all caps and is arranged to follow the curve of the circle.

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

# FEB -3 2012

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

Re: K994286 Trade/Device Name: ZMRTM Hip System Porous Revision 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, LWJ Dated: December 17, 1999 Received: December 20, 1999

Dear Mr. Williman:

This letter corrects our substantially equivalent letter of March 10, 2000.

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 (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.

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Page 2 - Mr. Daniel Williman

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.

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.

cerely yours,

For

rk N. Melkerson

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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# Indications for Use

510(k) Number (if known): K994286

Device Name:

ZMR® Hip System - Porous Revision

### Indications for Use:

The ZMR Hip System is indicated for cementless revision hip arthroplasty. Arthroplasty should be performed only when more conservative methods of treatment have failed to provide symptomatic relief or when there is progressive disability.

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 (ODE)

(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

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**510(k) Number** K994286