FIXION UNIPOLAR MODULAR HEMI-HIP SYSTEM (FIXION UH)

K014072 · Disc-O-Tech Medical Technologies, Ltd. · KWY · Mar 8, 2002 · Orthopedic

Device Facts

• Record ID: K014072
• Device Name: FIXION UNIPOLAR MODULAR HEMI-HIP SYSTEM (FIXION UH)
• Applicant: Disc-O-Tech Medical Technologies, Ltd.
• Product Code: KWY · Orthopedic
• Decision Date: Mar 8, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3390
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Fixion Unipolar Modular Hemi-Hip System is intended for use as a hemi hip replacement in case of: - Femoral head/neck fractures or non-unions - Aseptic necrosis of the femoral head/neck - Osteo-, rheumatoid, and post-traumatic arthritis of the hip, with minimal acetabular involvement

Device Story

Modular hemi-hip replacement system; consists of metallic or alumina ceramic stem and neck components. Used in orthopedic surgery for partial hip replacement. Fixation achieved via saline-inflated stem; inflation causes reinforcement bars to abut medullary canal wall, providing axial and rotational stability. Saline is non-compressible, biocompatible fluid. Device provides structural support for hip joint; intended to restore function in patients with femoral head/neck pathology. Surgeon operates device during implantation procedure.

Clinical Evidence

Bench testing only. Conforms to ISO 7206-8 (endurance performance of stemmed femoral components) and FDA draft guidance documents for femoral stem prostheses, mechanically locked modular implant components, and ceramic ball hip systems.

Technological Characteristics

Modular hemi-hip prosthesis; materials include 316LVM stainless steel and alumina ceramic. Fixation via saline-inflated stem with reinforcement bars. Conforms to ISO 7206-8. No software or electronic components.

Indications for Use

Indicated for patients requiring hemi-hip replacement due to femoral head/neck fractures, non-unions, aseptic necrosis, or hip arthritis (osteo-, rheumatoid, or post-traumatic) with minimal acetabular involvement.

Regulatory Classification

Identification

A hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis is a two-part device intended to be implanted to replace the head and neck of the femur. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a snap-fit acetabular component made of an alloy, such as cobalt-chromium-molybdenum, and ultra-high molecular weight polyethylene. This generic type of device may be fixed to the bone with bone cement (§ 888.3027) or implanted by impaction.

Predicate Devices

• Elite® Modular Hip System (not specified)
• S-ROM Total Hip System (not specified)
• Fixion™ Interlocking PF Intramedullary Nailing System (not specified)
• Link® Reconstruction Hip (not specified)
• Biolox® Alumina Ceramic Femoral Head (not specified)

Submission Summary (Full Text)

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#### 510 (K) Summary

Disc-O-Tech Medical Technologies Ltd.'s Fixion™ Unipolar Modular Hemi-

8 2002 MAR

Hip System

K014072
page 1 of 2

Company Name Disc-O-Tech Medical Technologies, Ltd. 3 Hasadnaot St. Herzlia, 46728, Israel

# Submitter's Name and Contact Person

Jonathan S. Kahan, Esq. Regulatory Counsel Hogan & Hartson L.L.P. 555 Thirteenth Street, NW Washington, DC 20004 Tel.: [phone] Fax: [phone]

#### Date Prepared

March 6, 2002

# Trade/Proprietary Name

Fixion™ Unipolar Modular Hemi-Hip System ("Fixion UH")

## Classification Name

Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis

#### Predicate Devices

The Fixion UH intended use, materials and accessories are substantially equivalent to those used in Depuy Orthopeadics' Elite® Modular Hip System and S-ROM Total Hip System, as well as Disc-O-Tech's Fixion™ Interlocking PF Intramedullary Nailing System. The Fixion UH is also substantially equivalent to Link America, Inc.'s Link® Reconstruction Hip and to Smith and Nephew's Biolox® Alumina Ceramic Femoral Head.

# Performance Standards

The Fixion UH conforms to the requirements of ISO 7206-8 (1995) "Implants for Surgery Partial and Total Hip Joint Prostheses - Part 8: Endurance Performance of Stemmed Femoral Components with Application of Torsion." The Fixion UH also conforms to FDA Draft Guidance Documents: Guidance Document for Femoral Stem Prostheses (1995) and Guidance Document for Testing Non-Articulating, "Mechanically Locked", Modular Implant Components (1995). In addition, the Fixion UH conforms to FDA Draft Guidance Document for the Preparation of Premarket Notification for Ceramic

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Ball Hip Systems (1995).

# Intended Use

The Fixion Unipolar Modular Hemi-Hip System is intended for use for The Polon Chaptical use as a hemi hip replacement in case of:

- Femoral head/neck fractures or non-unions ●
- Aseptic necrosis of the femoral head/neck .
- Osteo-, rheumatoid, and post-traumatic arthritis of the hip, with minimal . acetabular involvement

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# System Description

ystem Description
The Fixion UH is a modular hemi-hip replacement system, which is composed The I Mori of I is a land neck part ("stem") with an expandable femoral of a metazie relition from in various dimensions from metal or Alumina ceramic for use during partial hip replacement.

# Substantial Equivalence

The Fixion UH System has substantially equivalent intended use and indications for use as the Elite Modular Hip System and the other predicates, i.e., replacement of hips.

The performance characteristics of the Fixion UH have been tested and found to meet the specifications through a series of bench tests.

The Stem of the Fixion UH Unipolar Hemi-Hip System, like the Fixion™ PF Intramedullary Nail, is made of 316LVM Stainless Steel. The cross section of the Fixion UH stem body and the Fixion Interlocking PF Intramedullary nail is identical and circular with reinforcement bars.

Fixation of the Fixion UH Stem to the femur is further enhanced by its inflation with sterile saline similar to the Fixion PF Nail and results in the abutment of the 4 reinforcement bars to the medullary canal wall. Rotational and axial stability is aided by the shape of the Stem Neck. The inflation of the Fixion UH Stem with saline, which is a non-compressible biocompatible fluid, is identical to the cleared Fixion PF Nail and does not raise any new safety and efficacy issues.

#### CONFIDENTIAL

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines forming the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

#### 8 2002 MAR

Disc-O-Tech Medical Technologies, LTD. c/o Mr. Johnathan S. Kahan, Esq. Hogan & Hartson, L.L.P. 555 Thirteenth Street, NW Washington, DC 20004

Re: K014072

Trade Name: Fixion Unipolar Modular Hemi-Hip System (Fixion UH) Regulation Number: 21 CFR 888.3390 Regulation Name: Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis Regulatory Class: II Product Code: KWY Date: December 3, 2001 Received: December 10, 2001

Dear Mr. Kahan:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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 therely, maintons of the Act include requirements for annual registration, listing of devices, Condons provision 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 forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic rordly in the quality by over of provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Johnathan S. Kahan, Esq.

This letter will allow you to begin marketing your device as described in your Section 510(k) This lotter will anon-you're substantial equivalence of your device of your device to a legally prematicated 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 and If you desire specific da rios for for in vitro diagnostic devices), please contact the Office of additionally 21 CFTC Fat 0071. Additionally, for questions on the promotion and advertising of Compilance at [phone] First of Compliance at [phone]. Also, please note the your do roos, produced withing by reference to premarket notification™ (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Outler general mionmation on Jour versational 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,

Mark N Mckenn

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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Disc-()-Tech Medical Technologies, Ltd. Fixion UH Unipolar Modular Hemi-Hip System 510(k)

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# INDICATION FOR USE

| and the submit of the state of the same of the same of the same of the same of the status and the many of the many of the many of the many of the many of the many of the many | | 510(K) Number (if known): | K014072 | |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|---------------------------|---------|--|
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l'ixion Unipolar Modular Hemi-Hip System (Fixion™ UH) Device Name:

Indication for Use:

The Fixion Unipolar Modular Hemi-Hip System is intended for The Fixton 'Ompsemented use as a hemi hip replacement in cases of:

Femoral head/neck fractures or non-unions ﺳﻤ

- Aseptic necrosis of the femoral head/neck r
- Osteo-, rheumatoid, and post-traumatic arthritis of the hip. ﺮ with minimal acetabular involvement

# IP TENSE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED.

Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-off) Division of General. Restorative and Neurological Devices

510(k) Number:

| Prescription Use | X | OR |
|---------------------|---|----|
| (pg 21 CFR 801.109) | | |

(Division Sign-Off)

Division of General, Restorative

and Neurological Devices
Over the Counter Use_____________

510(k) Number .

CONFIDENTIAL

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