EXETER HIP SYSTEM WITH V40 TAPER

K011623 · Howmedica Osteonics Corp. · JDI · Jun 15, 2001 · Orthopedic

Device Facts

• Record ID: K011623
• Device Name: EXETER HIP SYSTEM WITH V40 TAPER
• Applicant: Howmedica Osteonics Corp.
• Product Code: JDI · Orthopedic
• Decision Date: Jun 15, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3350
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The subject Exeter V40™ Hip System components are intended for use in total hip replacement. They are intended for cemented use only. The subject components are intended for use with any Howmedica Osteonics Corp. acetabular component featuring a polyethylene bearing surface.

Device Story

Modified Exeter Hip System; cemented total hip replacement prosthesis. Features V40™ Taper trunnion design; includes additional stem/head sizes, insertion dimple on stems, reduced neck diameter, and wingless stem centralizer. Used in orthopedic surgery for hip replacement. Components interface with Howmedica Osteonics acetabular components with polyethylene bearing surfaces. Provides structural support for hip joint; restores function in patients with degenerative or traumatic hip conditions.

Clinical Evidence

Bench testing only. Testing conducted in accordance with ISO 7206-4 and 7206-6 to verify structural integrity of modified hip stems. Compatibility of Zirconia V40™ Femoral Heads with subject stems was demonstrated via bench testing.

Technological Characteristics

Cemented artificial hip system. Features V40™ Taper trunnion, modified stem geometry (neck diameter, insertion dimple), and wingless centralizer. Materials include metal and polymer. Testing performed per ISO 7206-4 and 7206-6. No software or electronic components.

Indications for Use

Indicated for patients with noninflammatory joint disease (osteoarthritis, avascular necrosis), rheumatoid arthritis, functional deformity, revision procedures, or nonunion/fractures of the proximal femur with head involvement unmanageable by other techniques.

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

• Exeter Hip System

Submission Summary (Full Text)

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# JUN 1 5 2001

K011623

Modified Exeter Hip System with V40™ Taper

#### Special 510(k) Premarket Notification

### Special 510(k) Summary - Modified Exeter Hip System with V40™ Taper

Proprietary Name: Common Name : Classification Name and Reference:

Proposed Regulatory Class : Device Product Code : For Information contact:

Exeter Hip System with V40TM Taper Artificial Hip System Prosthesis. Hip. Semi-Constrained. Metal/Polymer/Metal, Cemented, 21 CFR \$888.3350 Class II 87 JDI Nancy J. Rieder Howmedica Osteonics Corp. 59 Route 17 Allendale, New Jersey 07401 Phone: [phone] Fax: [phone]

#### Description/Technologicol Comparison

This Special 510(k) covers a modified Exeter Hip System which differs from the existing, predicate Exeter Hip System primarily in that it features a different trunnion known as the V40™ Taper. In addition to the change in Exeter Hip Stems and Heads from the predicate trunnion design to the newer V40™ Taper, this submission includes some additional stem and head sizes, the addition of an insertion dimple on the stems, reduction in stem neck diameter, and a new wingless version of the stem centralizer component.

#### Intended Use

The subject Exeter V40™ Hip System components are intended for use in total hip replacement. They are intended for cemented use only. The subject components are intended for use with any Howmedica Osteonics Corp. acetabular component featuring a polyethylene bearing surface.

#### Indications:

- Noninflammatory joint disease including osteoarthritis and avascular necrosis, .
- Rheumatoid arthritis, .

Page 3

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Modified Exeter Hip System with V40™ Taper

- Correction of functional deformity, .
- Revision procedures where other treatments or devices have failed, .
- Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with . head involvement that are unmanageable using other techniques.

### Testing Summary

The subject modified hip stems have successfully endured testing in accordance with ISO 7206-4 and 7206-6. Testing of commercially available Zirconia V40™ Femoral Heads demonstrated their suitability for use with the subject hip stems.

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JUN 1 5 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Nancy J. Rieder Regulatory Affairs Specialist Howmedica Osteonics Corporation 59 Route 17 Allendale, New Jersey 07401-1677

Re: K011623

Trade Name: Exeter Hip System with V40" Taper Regulation Number: 888.3350 Regulatory Class: II Product Code: JDI Dated: May 24, 2001 Received: May 25, 2001

Dear Ms. Rieder:

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 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.

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### Page 2 - Ms. Nancy J. Rieder

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 additionally, of 59. Additionally, for questions on the promotion and advertising of your device, (2017) 594-1639. Tradition 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 mormaton on Jour Soll-free number [phone] or at [phone], or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Mesturth

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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## 510(k) Number (if known): K011623

# Device Name: Modified Exeter Hip System with V40TM Taper

The subject Exeter V40™ Hip System components are intended for use in total hip replacement. They are intended for cemented use only. The subject components are intended for use with any Howmedica Osteonics Corp. acetabular component featuring a polyethylene bearing surface.

#### Indications:

- Noninflammatory joint disease including osteoarthritis and avascular necrosis, .
- Rheumatoid arthritis, .
- Correction of functional deformity, .
- Revision procedures where other treatments or devices have failed, .
- Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with ● head involvement that are unmanageable using other techniques.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

OR Prescription Use

Over-The-Counter Use (Per 21 CFR 801.109) (Optional Format 1-2-96)

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

510(k) Number k011623