THE TAPER-FIT TOTAL HIP SYSTEM

K992234 · Corin USA · JDG · Nov 10, 1999 · Orthopedic

Device Facts

• Record ID: K992234
• Device Name: THE TAPER-FIT TOTAL HIP SYSTEM
• Applicant: Corin USA
• Product Code: JDG · Orthopedic
• Decision Date: Nov 10, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3360
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Relief of pain and restoration of hip function following the effects of osteo, theumatoid and inflammatory arthritis, post-trauma disease, avascular necrosis, and total hip revision. These femoral stems are intended for use with bone cement.

Device Story

Taper-Fit Total Hip System is a modular femoral hip prosthesis; consists of 4 stem sizes with 38mm/45mm offsets and a CDH stem with 36mm offset. Device is double-tapered, collarless, and highly polished. Used to resurface femoral hip joints and reinstate function. Operated by orthopedic surgeons in clinical/surgical settings. System includes a Polymethylmethacrylate (PMMA) stem centralizer. Used in conjunction with a 316L stainless steel modular head. Device is implanted to address degenerative joint conditions and revision needs; provides structural support for hip joint function.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Modular femoral stem; material: High Nitrogen Stainless Steel (BS 7251 Pt 9); modular head: 316L Stainless Steel (BS 7252 Pt 1, ISO 5832-1); includes Polymethylmethacrylate (PMMA) stem centralizer; double-tapered, collarless, highly polished geometry; intended for cemented fixation.

Indications for Use

Indicated for patients requiring relief of pain and restoration of hip function due to osteoarthritis, rheumatoid arthritis, inflammatory arthritis, post-trauma disease, avascular necrosis, or total hip revision. Intended for use with bone cement.

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.

Submission Summary (Full Text)

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# NOV 1 0 1999

#### 510(k) SUMMARY

Corin Medical Name of Company: The Corinium Centre Cirencester Gloucestershire GL7 1YJ England

Name of Device: Taper-Fit Total Hip System

Device Description: The Taper-Fit Total Hip System consists of 4 sizes of stem. For each stem size there are 2 offsets 38 mm & 45 mm. A CDH stem is also available with a 36 mm offset.

The modular stem is manufactured from Stainless Steel in accordance with BS 7251 Pt 9 -Specification for High Nitrogen Stainless Steel and is provided with a Polymethylmethacrylate Stem Centralizer. The devices are used to resurface femoral hip joints and reinstate function following the degenerative effects of osteo and theumatoid arthritis, post trauma disease, avascular neurosis and septic/aseptic total hip revision.

The stem is double tapered, collarless and highly polished. The stem is used with a 316L Stainless Steel Modular Head. This stainless steel complying to BS 7252 Pt 1: 1997, ISO 5832-1:1997 Metallic Materials for Surgical Implants, Part 1. Specification for Wrought Stainless Steel.

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 0 1999

Mr. Craig Corrance President Corin U.S.A. 10500 University Center Drive, Suite 190 Tampa, Florida 33612

K992234 Re: Corin Taper-Fit Total Hip System Trade Name: Regulatory Class: II Product Code: JDG Dated: October 7, 1999 Received: October 12, 1999

#### Dear Mr. Corrance:

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 controls provisions The general controls provisions of the Act 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. ਸੇ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: 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 In addition, FDA may publish further announcements action. 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.

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### Page 2 - Mr. Craig Corrance

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.

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note one regulation entitled, "Misbranding by reference to
the regulation entitled, "Misbranding by reference to information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Dillard III James E. Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K992234

Device Name:_Taper-Fit Total Hip System

Indications For Use: Relief of pain and restoration of hip function following the effects of osteo, theumatoid and inflammatory arthritis, post-trauma disease, avascular necrosis, and total hip revision.

These femoral stems are intended for use with bone cement.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K94 2234

Prescription Use_ ✓ (Per 21 CFR 801.109) OR

Over-The-Counter Use*_*_

(Optional Format 1-2-96)