ZMR HIP SYSTEM-XL, MODELS 9921, 9922 AND 9923

K031572 · Zimmer, Inc. · LPH · Jun 24, 2003 · Orthopedic

Device Facts

• Record ID: K031572
• Device Name: ZMR HIP SYSTEM-XL, MODELS 9921, 9922 AND 9923
• Applicant: Zimmer, Inc.
• Product Code: LPH · Orthopedic
• Decision Date: Jun 24, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3358
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ZMR* 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 Hip System-XL is a modular femoral stem for cementless revision hip arthroplasty; constructed from Tivanium (Ti-6Al-4V alloy). Device consists of three intraoperatively assembled components: proximal body, distal stem, and compression nut. Features two modular junctions: head/neck and midstem. Used by surgeons in clinical settings to replace femoral components in patients with inadequate bone stock. Provides structural support for hip joint reconstruction; benefits patients by restoring hip function when conservative treatments fail.

Clinical Evidence

Bench testing only.

Technological Characteristics

Modular femoral stem; material: Tivanium (Ti-6Al-4V alloy); cementless fixation; modular junctions at head/neck and midstem; three-piece assembly (proximal body, distal stem, compression nut).

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

• ZMR Hip System-Revision Taper (K992667)
• ZMR Hip System-Porous Revision (K994286)

Submission Summary (Full Text)

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JUN 2 4 2003

## Special 510(k): Device Modification

**ZMR® Hip System-XL**
**Summary of Safety and Effectiveness**

**Submitter:**

Contact Person:

Date:.

Trade Name:

Common Name:

Classification Name

and Reference:

Predicate Devices:

Device Description:

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

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

May 16, 2003

ZMR® Hip System-XL

Total hip prosthesis

Hip joint metal/polymer semiconstained uncemented prosthesis, no 21 CFR reference

Hip joint metal/polymer/metal semiconstrained porous coated uncemented prosthesis, 21 CFR 888.3358

ZMR® Hip System-Revision Taper, manufactured by Zimmer, Inc., K992667, cleared October 27, 1999

ZMR® Hip System-Porous Revision, manufactured by Zimmer, Inc., K994286, cleared March 10, 2000

Like its predicates, the ZMR® Hip System-XL prosthesis is a modular 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 "body," a distal stem, and a compression nut.

K031572
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Intended Use:

The ZMR* 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 Device:

The modifications to the ZMR® Hip System change neither the intended use nor the fundamental scientific technology of the device. The ZMR XL components are manufactured, packaged and sterilized using the same processes and materials.

Performance Data:

Non-clinical performance testing demonstrated that the device is equivalent to the predicate.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three heads, representing the department's mission to protect the health of all Americans. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

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

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

FEB - 3 2012

Re: K031572 Trade/Device Name: ZMR™ Hip System-XL 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: May 16, 2003 Received: June 3, 2003

Dear Mr. Williman:

This letter corrects our substantially equivalent letter of June 24, 2003.

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,

Mark 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): K031572

Device Name:

ZMR® Hip System – XL

## 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)

(Please do not write below this line - Continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

i

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

510(k) Number K031572

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