TRI-FIT FEMORAL STEM

K010243 · Corin USA · LWJ · Feb 15, 2001 · Orthopedic

Device Facts

• Record ID: K010243
• Device Name: TRI-FIT FEMORAL STEM
• Applicant: Corin USA
• Product Code: LWJ · Orthopedic
• Decision Date: Feb 15, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3360
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Tri-Fit Total Hip System is indicated for the relief of pain and restoration of hip function following the effects of osteo, rheumatoid and inflammatory arthritis, post-traumatic disease effects, hip fractures, avascular necrosis and total hip revision. Tri-Fit Hip System components are intended to be used in press-fit applications or with bone cement.

Device Story

Modular femoral hip prosthesis; Ti6Al4V substrate; proximal commercially pure titanium plasma spray coating. Accepts cobalt-chrome or ceramic femoral heads via 12/14 Eurocone male taper. Available in six sizes (7.5mm to 20mm distal diameter). Used by orthopedic surgeons in clinical settings for total hip arthroplasty. Implanted via press-fit or cemented technique to replace diseased or damaged hip joint components. Provides structural support for hip function; restores mobility; relieves pain. Modifications from predicate include proximal coating, distal shotblast finish, Eurocone taper, and introducer holes.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Material: Ti6Al4V substrate with commercially pure titanium plasma spray coating. Modular design with 12/14 Eurocone male taper. Distal diameter range: 7.5mm to 20mm. Distal surface finish: shotblast. Mechanical fixation: press-fit or bone cement.

Indications for Use

Indicated for patients requiring hip pain relief and functional restoration due to osteoarthritis, rheumatoid arthritis, inflammatory arthritis, post-traumatic disease, hip fractures, avascular necrosis, or total hip revision.

Regulatory Classification

Identification

A hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis is a device intended to be implanted to replace a portion of the hip joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum. This generic type of device includes designs which are intended to be fixed to the bone with bone cement (§ 888.3027) as well as designs which have large window-like holes in the stem of the device and which are intended for use without bone cement. However, in these latter designs, fixation of the device is not achieved by means of bone ingrowth.

Predicate Devices

• CTi II femoral stem

Submission Summary (Full Text)

{0}------------------------------------------------

# FEB 1 5 2001

## KO10243 510(k) SUMMARY

#### Device: Tri-Fit Femoral Hip System

Date: 01/23/01

Applicant's name:

Corin USA 10500 University Center Drive, Suite 190 Tampa, FL 33612

Phone: [phone] [phone] Fax:

Contact person:

Joel Batts, Regulatory Affairs Manager

Classification name: Prosthesis, hip, semi-constrained, metal/polymer, uncemented

Product codes: LWJ

C.F.R. section: not specified

Device class: II

Classification panel: Orthopedic

#### Indications for use

Tri-Fit Total Hip System is indicated for the relief of pain and restoration of hip function following the effects of osteo, rheumatoid and inflammatory arthritis, post-traumatic disease effects, hip fractures, avascular necrosis and total hip revision. Tri-Fit Hip System components are intended to be used in press-fit applications or with bone cement.

#### Device description

The Tri-Fit Femoral Stem is a modular stem that accepts femoral heads onto its 12/14 Eurocone male taper (either cobalt-chrome or ceramic femoral heads). The stem

{1}------------------------------------------------

substrate is made from a Ti6Al4V and is proximally coated with commercially pure titanium plasma spray. The stem is available in six (6) sizes ranging from 7.5mm to 20mm distal diameter. Four (4) modifications made to the CTi II femoral stem are comprised in the Tri-Fit femoral stem: Modifications to proximal surface coating, distal surface finish, trunnion dimensions and addition of stem introducer holes. These changes do not effect the fundamental scientific technology or the indications for use.

#### Substantial equivalence basis

The sponsor claims substantial equivalence (SE) of the Tri-Fit femoral stem to the CTi II femoral stem on which the Tri-Fit is based. The Tri-Fit contains four (4) modifications of the original CTi II stem which are as follows:

> 1. Addition of unalloyed titanium plasma sprayed coating to proximal portion of stem

2. Change 11/13 trunnion taper dimensions to Eurocone 12/14

3. Addition of two holes in the proximal face, lateral to the trunnion for stem introducer instrument attachment

4. Change polished finish of distal stem to shotblast finish

Bench testing was carried out to validate the modifications as determined by the Risk Analysis provided in Section 9. The findings indicate that these design modifications will not change the safety or efficacy of the previous design. Summary results are located in Section 7, pages 1 and 2.

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The logo is black and white.

Public Health Service

FEB 1 5 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Joel K. Batts Regulatory Affairs Manager Corin U.S.A. 10500 University Center Drive, Suite 109 Tampa, Florida 33612

Re: K010243 Trade Name: Tri-Fit Femoral Stem Regulatory Class: II Product Codes: LWJ and LZO Dated: January 24, 2001 Received: January 25, 2001

Dear Mr. Batts:

We have reviewed your Section 510(k) 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). You may, therefore, market the device, subject to the general control provisions of the Act. The general control 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good -Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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.

{3}------------------------------------------------

### Page 2 - Mr. Joel K. Batts

If you desire specific advice for your device on our labeling regulation (21 CFF Part 801 and If you desire specific acvice for your as ic devices), please contact the Office of Compliance at additionally 607.10 for mire craguestions on the promotion and advertising of your device, [phone]. Additionally, 101 quest at [phone]. Also, please note the regulation prease contact the Orice of Comphanse (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Information on your responsionnees and more [phone] or at [phone], or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Mark A Millman

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

{4}------------------------------------------------

Page **_ of _**

# 510(k) NUMBER (IF KNOWN):_____________________________________________________________________________________________________________________________________________________

# DEVICE NAME: Tri-Fit Total Hip System

### INDICATIONS FOR USE:

Tri-Fit Total Hip System is indicated for the relief of pain and restoration of hip function following the effects of osteo, rheumatoid and inflammatory arthritis, post-traumatic disease effects, hip fractures, avascular necrosis and total hip revision. Tri-Fit Hip System Components are intended to be used in press-fit applications or with bone cement.

## (PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED.)

Concurrence of CDRH, Office of Device Evaluation (ODE)

for Mark n Mellers

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

510(k) Number. K010243