HOWMEDICA ASYMMETRIC STEM VITALOCK CLUSTER & SPIKED SHELLS, AND ACETABULAR SHELLS WITH MESH INGROWTH SURFACE WITH PERI-A

K982248 · Howmedica, Inc. · LPH · Aug 31, 1998 · Orthopedic

Device Facts

• Record ID: K982248
• Device Name: HOWMEDICA ASYMMETRIC STEM VITALOCK CLUSTER & SPIKED SHELLS, AND ACETABULAR SHELLS WITH MESH INGROWTH SURFACE WITH PERI-A
• Applicant: Howmedica, Inc.
• Product Code: LPH · Orthopedic
• Decision Date: Aug 31, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3358
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Howmedica® Asymmetric Stem, Vitalock® Cluster & Spiked Shells, and Acetabular Shells with Mesh Ingrowth Surface with Peri-Apatite™ Coating are intended to be used in the primary uncemented reconstruction of the proximal femur and acetabulum.

Device Story

Hip prosthesis system consisting of Asymmetric Stem, Vitalock Cluster/Spiked Shells, and Mesh Ingrowth Shells; features Peri-Apatite (hydroxyapatite) coating on porous surfaces. Used by orthopedic surgeons in clinical settings for primary hip reconstruction. Device provides structural support for femur and acetabulum; hydroxyapatite coating facilitates biological fixation. Output is physical implant integration with patient bone. Benefits include stable prosthetic fixation. Device is not labeled for enhanced clinical/radiographic performance or long-term stable fixation beyond conventional porous coated prostheses.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on design, material, and intended use comparisons to predicate devices.

Technological Characteristics

Hip prosthesis components (stems and shells) with porous ingrowth surfaces. Features a thin layer of hydroxyapatite (Peri-Apatite™) coating. Uncemented design. Materials and design are identical to previously cleared predicates, with the addition of the hydroxyapatite coating.

Indications for Use

Indicated for primary uncemented reconstruction of the proximal femur and acetabulum.

Regulatory Classification

Identification

A hip joint metal/polymer/metal semi-constrained porous-coated uncemented 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 has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.

Predicate Devices

• Meridian® ST Stem and Vitalock® Solid Back Shell with Peri-Apatite™ Coating (K971206)
• Asymmetric Stem (K955871)
• Vitalock® Cluster Shell (K933102)
• Vitalock® Spiked Shell (K953664)
• Mesh Ingrowth Shells (K973163)

Submission Summary (Full Text)

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AUG 3 1 1998

K98 2248

## 510(k) Summa

Howmedica® Asymmetric Stem, Vitalock® Cluster & Spiked Shells, Proprietary Name: and Acetabular Shells with Mesh Ingrowth Surface with Peri-Apatite™ Coating

Porous Coated Hip Prosthesis and Acetabular Shell with Common Name: Precipitated Calcium Phosphate Coating

21 CFR 888.3358 Classification Name and Reference: Hip Joint Metal/Polymer/Metal semi-constrained Porous coated uncemented prosthesis.

Proposed Regulatory Class: Class II

Device Product Code: LPH/MEH

Frank Maas For information contact: Manager, Regulatory Affairs Howmedica Inc. 359 Veterans Boulevard Rutherford, NJ 07070 Telephone: [phone] [phone] Fax: Date Summary Prepared: 6-26-98

The Howmedica® Asymmetric Stem, Vitalock® Cluster & Spiked Shells, and Acetabular Shells with Mesh Ingrowth Surface with Peri-Apatite™ Coating are intended to be used in the primary uncemented reconstruction of the proximal femur and acetabulum. These devices are identical to the previously cleared Asymmetric Stem, Vitalock® Cluster Shell, Vitalock® Spiked Shell and Mesh Shells, except for the presence of a thin layer of hydroxyapatite coating applied to the porous coated surface.

The Peri-Apatite™ coating is the same coating previously characterized and cleared in 510(k) K971206.

The substantial equivalence of these devices is based on an equivalence in intended use, materials, design, and relative indications and contraindications to Howmedica's Meridian® ST Stem and Vitalock® Solid Back Shell with Peri-Apatite™ Coating (K971206), Asymmetric Stem (K955871), Vitalock® Cluster Shell (K933102), Vitalock® Spiked Shell (K953664), and Mesh Ingrowth Shells (K973163).

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a symbol. The symbol consists of a stylized caduceus, which is a traditional symbol of medicine, with three wavy lines representing the three branches of government.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 3 1 1998

Mr. Frank Maas Manager, Regulatory Affairs Howmedica, Inc. Pfizer Hospital Products Group 359 Veterans Boulevard Rutherford, New Jersey 07070-2584

K982248 Re : Howmedica® Asymmetric Stem, Vitalock® Cluster and Spiked Shells, and Acetabular Shells with Mesh Ingrowth Surface with Peri-Apatite™ Coating Requlatory Class: II Product Codes: MEH and LPH Dated: June 26, 1998 Received: June 26, 1998

Dear Mr. Maas:

We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined the devices are 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). This decision is based on consideration of the specific design of stem and coating composition detailed in this application. You may, therefore, market the device, subject to the general controls provisions of the Act and the following limitation:

You may not label or in any way promote these devices for "enhanced clinical or radiographic performance, enhanced biological fixation and/or long-term stable fixation." The data presented support equivalence with no additional claims over a conventional porous coated hip prosthesis (i.e., biological fixation only).

Additional limitations for more specific claims of safety and effectiveness may be forthcoming. Should additional limitations be applied you will be contacted in writing to inform you of the additional labeling limitations.

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.

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## Page 2 - Mr. Frank Maas

You may market your device under the above limitations as class II devices. These devices would be considered not substantially equivalent to a legally marketed predicate device if labeled with other intended uses and/or claims of safety or effectiveness. Any other intended uses or claims may cause the device to be classified into Class III under Section 513 (f) of the Act. Class III devices are required to have an approved premarket approval (PMA) application prior to marketing.

Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to A substantially equivalent determination assumes 895. compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. In addition, FDA may publish further announcements concerning this your device in the Federal Reqister. Please note: 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.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification immediately. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and 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

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## Page 3 - Mr. Frank Maas

at its toll-free number [phone] or [phone] or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia 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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## Indications for Use

K982248 510(k) Number (if known):

Howmedica® Asymmetric Stem, Vitalock® Cluster & Spiked Shells, Device Name: and Acetabular Shells with Mesh Ingrowth Surface with Peri-Apatite ™ Coating

Indications for Use:

The Howmedica® Asymmetric Stem, Vitalock® Cluster & Spiked Shells, and Mesh Ingrowth Shells with Peri-Apatite™ Coating are intended to be used in the primary ingromented reconstruction of the proximal femur and acetabulum, respectively.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

12 Prescription Use (Per 21 CFR 801.108)

\$\frac{k}{q}\$ OR

Over-The-Counter Use No

(Optional Format 1-2-96)

(Division) Sign-Off)
Division of General Restorative Devices,
510(k) Number K982248