ACETABULAR SHELLS WITH MESH INGROWTH SURFACE

K973163 · Howmedica Corp. · LPH · Nov 21, 1997 · Orthopedic

Device Facts

• Record ID: K973163
• Device Name: ACETABULAR SHELLS WITH MESH INGROWTH SURFACE
• Applicant: Howmedica Corp.
• Product Code: LPH · Orthopedic
• Decision Date: Nov 21, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3358
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Acetabular Shells with Mesh Ingrowth Surface are intended to be used for uncemented, primary reconstruction of the acetabular portion of the hip joint during total hip arthroplasty.

Device Story

Modular acetabular component consisting of Vitallium acetabular shells with integrally cast mesh ingrowth surface. Available in four styles: solid back, solid back with visualization hole, cluster shell with screw holes, and pre-assembled with plastic insert. Used by orthopedic surgeons in clinical settings for primary total hip arthroplasty. Device provides stable acetabular reconstruction; mesh surface facilitates bone ingrowth. Surgeon selects appropriate shell diameter based on patient anatomy; shell implanted uncemented to replace acetabular surface. Benefits include secure fixation and restoration of hip joint function.

Clinical Evidence

No clinical data. Equivalence demonstrated via mechanical and biological bench testing comparing cast mesh surface to sintered beaded porous coating.

Technological Characteristics

Vitallium (cobalt-chromium alloy) acetabular shells; integrally cast mesh ingrowth surface. Modular design with multiple styles (solid, cluster, pre-assembled). Uncemented fixation. No software or electronic components.

Indications for Use

Indicated for patients undergoing primary total hip arthroplasty requiring uncemented reconstruction of the acetabular portion of the hip joint.

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

• Vitalock® Solid Back Shells (K930223, K935731, K952397)
• Vitalock® Cluster Cup (K933102)
• Trilogy™ Acetabular Cup (K954698)

Submission Summary (Full Text)

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K973/63

## 510(k) Summary

NOV 2 1 1997

Proprietary Name: Acetabular Shells with Mesh Ingrowth Surface

Common Name: Modular Acetabular Component

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: JDI

مز-سن

For information contact: Frank Maas Manager, Regulatory Affairs Howmedica Inc. 359 Veterans Boulevard Rutherford, NJ 07070 Telephone: [phone] Fax: [phone] Date Summary Prepared: 8-22-97

The Acetabular Shells with Mesh Ingrowth surface are a series of Vitallium® acetabular components intended for the primary reconstruction of the acetabulum during total hip arthroplasty.

These components are designed with a mesh ingrowth surface that is integrally cast in to the shell substrate. The shells are available in a range of outer diameters to accommodate various anatomical requirements. These shells are available in four styles; a solid back, a solid back with visualization hole, a cluster shell with screw holes, and a shell that is pre-assembled with the plastic insert.

The substantial equivalence of these devices is based on an equivalence in intended use, design, materials, manufacturing methods, and indications and contraindications to Howmedica's Vitalock® Solid Back Shells(K930223, K935731, K952397), Vitalock® Cluster Cup(K933102), and Zimmer's Trilogy™ Acetabular Cup(K954698).

Mechanical as well as Biological testing was presented to demonstrate the equivalence of the cast mesh surface to that of a sintered beaded porous coating.

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with its wings spread, and three human profiles are visible within the eagle's body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle image.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

K973163 Re: Acetabular Shells with Mesh Ingrowth Surface Trade Name: Requlatory Class: II Product Code: LPH August 22, 1997 Dated: Received: August 25, 1997

Dear Mr. Maas:

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. 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 requlation may result in requlatory 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.

NOV 21 1997

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## Page 2 - Mr. Frank Maas

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. Cola M. Witton, Ph. D., M.

a M. Witten, Ph.D., M.D. Ce 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

510(k) Number (if known):

Device Name: Acetabular Shells with Mesh Ingrowth Surface

Indications for Use:

The Acetabular Shells with Mesh Ingrowth Surface are intended to be used for uncemented, primary reconstruction of the acetabular portion of the hip joint during total hip arthroplasty.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

1

OR

Over-The-Counter Use_

(Optional Format 1-2-96)

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