36MM ORTHINOX V40 FEMORAL HEAD COMPONENTS

K031730 · Howmedica Osteonics Corp. · JDI · Aug 29, 2003 · Orthopedic

Device Facts

• Record ID: K031730
• Device Name: 36MM ORTHINOX V40 FEMORAL HEAD COMPONENTS
• Applicant: Howmedica Osteonics Corp.
• Product Code: JDI · Orthopedic
• Decision Date: Aug 29, 2003
• 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

36mm Orthinox® V40™ femoral head components designed for total hip arthroplasty; intended for cemented use with Howmedica Osteonics acetabular components featuring polyethylene bearing surfaces. Device functions as modular prosthetic head articulating within acetabular cup. Used by orthopedic surgeons in clinical/hospital settings. Provides structural replacement for femoral head; restores joint function; alleviates pain associated with degenerative or traumatic hip conditions.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Material: Orthinox® (Stainless Steel Alloy per ASTM F1586 and ISO 5832-9). Form factor: 36mm femoral head with -5mm, +0mm, and +5mm offsets. Connectivity: None (mechanical implant). Sterilization: Not specified (standard medical device processing).

Indications for Use

Indicated for patients requiring total hip replacement due to noninflammatory joint disease (osteoarthritis, avascular necrosis), rheumatoid arthritis, functional deformity, revision procedures, or treatment of nonunion, femoral neck, and trochanteric 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

• 22mm-32mm V40™ Orthinox® Femoral Head Components (K011623)

Submission Summary (Full Text)

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## AUG 2 9 2003

Special 510(k) Summary - Addition of 36mm Orthinox® V40™ Femoral Heads To The Exeter Series

| | SUBJECT DEVICE | PREDICATE DEVICE |
|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|
| Proprietary Name: | 36mm Orthinox® V40™ Femoral<br>Head Components | 22mm-32mm V40™ Orthinox®<br>Femoral Head Components |
| Common Name: | Femoral Head Component | Femoral Head Component |
| Classification Name and<br>Reference: | 21 CFR §888.3350<br>Hip Joint Metal/ Polymer Semi-<br>constrained Cemented Prosthesis | 21 CFR §888.3350<br>Hip Joint Metal/ Polymer Semi-<br>constrained Cemented Prosthesis |
| Proposed Regulatory Class: | II | II |
| Device Product Code: | (87) JDI | (87) JDI |
| For Information contact: | Jennifer A. Daudelin, Regulatory Affairs<br>Howmedica Osteonics Corp.<br>59 Route 17<br>Allendale, NJ 07401-1677<br>[phone]<br>Fax: [phone]<br>Email: [e-mail] | |
| Date Summary Prepared: | May 27, 2003 | |

This Special 510(k) submission is intended to add 36mm Orthinox® V40™ femoral head components in -5mm, +0mm, and +5mm offsets to the Exeter Femoral Bearing Series. The intended use, manufacturing methods, materials, packaging and sterilization of the subject device are identical to those of predicate devices. The predicate Orthinox® V40™ femoral bearing components were found substantially equivalent via the 510(k) process in K011623. The Orthinox® V40™ femoral head components are fabricated from Orthinox®, a Stainless Steel Alloy conforming to ASTM F1586 and ISO 5832-9. Like the predicate devices, the subject devices are intended for use with femoral stems and acetabular components in primary or revision total hip arthroplasty.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure with three curved lines representing its body and wings.

AUG 2 9 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Debra Bing Regulatory Affairs Manager Howmedica Osteonics Corp. 59 Route17 Allendale, New Jersey 07401

Re: K031730

Trade/Device Name: Addition of 36mm Orthinox® V40™ Femoral Heads to the Exeter Series Regulation Number: 21 CFR 888.3350 Regulation Name: Hip joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: JDI Dated: August 5, 2003 Received: August 5, 2003

Dear Ms. Bing:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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 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 (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 product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Debra Bing

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International 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,

Sincerely yours,

Mark A Milken

Celia 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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## Indications for Use

510(k) Number (if known):

Device Name: 36mm Orthinox® V40™ Femoral Heads

Indications for 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,
- 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.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use ***_*** OR Over-The-Counter Use
(Per 21 CFR 801.109) of Mark N Milkerm (Optional Format 1-2-96)
for
Division Sign-Off)
Division of General, Restorative
and Neurological Devices
510(k) Number **_** K031730