DUAL OFFSET PERFECTA IMC HIP STEM

K972641 · Wrightmedicaltechnologyinc · JDI · Oct 9, 1997 · Orthopedic

Device Facts

• Record ID: K972641
• Device Name: DUAL OFFSET PERFECTA IMC HIP STEM
• Applicant: Wrightmedicaltechnologyinc
• Product Code: JDI · Orthopedic
• Decision Date: Oct 9, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3350
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

This device is indicated in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1 . Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2. Inflammatory degenerative joint disease such as rheumatoid arthritis: 3. Correction of function deformity: Revision procedures where other treatments or devices have 4. failed; and 5. Treatment of nonunion, femoral neck, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques. This device is intended for use with bone cement.

Device Story

Dual Offset PERFECTA® IMC Hip Stem is a femoral hip stem implant designed for total hip arthroplasty. Manufactured from cobalt chrome alloy; intended for use with bone cement. Device features standard and long lengths with a collar. Used by orthopedic surgeons in clinical settings to replace the femoral head/neck, providing pain relief and improved hip function for patients with degenerative joint disease or fractures. Implanted via surgical procedure; provides structural support for the hip joint.

Clinical Evidence

Bench testing only. Testing demonstrated the device withstands a load of 2300N for at least 5 million cycles at 10 hertz.

Technological Characteristics

Material: Cobalt chrome alloy (ASTM F 799). Design: Femoral hip stem with collar, available in standard and long lengths. Energy source: None (mechanical implant). Connectivity: None. Sterilization: Not specified.

Indications for Use

Indicated for skeletally mature patients undergoing total hip arthroplasty for non-inflammatory/inflammatory degenerative joint disease (osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, hip dysplasia, rheumatoid arthritis), functional deformity correction, revision procedures, or treatment of nonunion, femoral neck, and trochanteric fractures of the proximal femur with head involvement.

Regulatory Classification

Identification

A hip joint metal/polymer semi-constrained cemented 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).

Predicate Devices

• PERFECTA® IMC Hip Stem (K972641)

Submission Summary (Full Text)

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OCT - 9 1997

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Contact Person: Kim Tompkins July 14, 1997 Date:

# 510(k) Summary

| Trade Name: | Dual Offset PERFECTA® IMC Hip Stem, product line extension to<br>the PERFECTA® IMC Hip System |
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| Common Name: | Femoral Hip Stem |
| Classification: | Class II |
| Predicate Device: | PERFECTA® IMC Hip Stem manufactured by Wright Medical<br>Technology, Inc. |

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.

# Description/Intended Use

The Dual Offset PERFECTA® IMC Hip Stem is manufactured from cobalt chrome alloy (ASTM F 799). The stem is available in standard and long lengths and features a collar. The stem is designed to be used with bone cement.

This device is indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

- 1) non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia:
- 2) inflammatory degenerative joint disease such as rheumatoid arthritis:
- 3) correction of functional deformity:
- 4) revision procedures where other treatments or devices have failed; and,
- 5) treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

# Testina

Submitted testing indicates that the device should withstand a load of 2300N for at least 5 million cycles at 10 hertz.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT - 9 1997

Ms. Kim Tompkins Director, Clinical and Regulatory Affairs Wright Medical Technology, Inc. 5677 Airline Road Arlington, Tennessee 38002

Re: K972641 Dual Offset PERFECTA® IMC Hip Stem Trade Name: Requlatory Class: II Product Code: JDI Dated: July 14, 1997 Received: July 15, 1997

Dear Ms. Tompkins:

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 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 (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 requlations.

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Page 2 - Ms. Kim Tompkins

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 regulation (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 the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general 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,

C. Gale M. Whitten, Ph.D., M.

a M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### C. Indications for Use of the Device

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| | 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ | | K972641 | |
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| | | | . | |

### Device Name: Dual Offset PERFECTA® IMC Hip Stem

### Indications for Use:

This device is indicated in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

- 1 . Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
- 2. Inflammatory degenerative joint disease such as rheumatoid arthritis:
- 3. Correction of function deformity:
- Revision procedures where other treatments or devices have 4. failed; and
- 5. Treatment of nonunion, femoral neck, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

This device is intended for use with bone cement.

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

t. ceele

(Division Sign-Off) (Division Signi-On)
Division of General Restorative Devices 510(k) Number_12322641

Prescription Use X (Per 21 CFR 801.109)

Or

Over-the-Counter Use (Optional Format 1-2-96)