HARRIS/GALANTE POROUS (HGP) HIP PROSTHESIS WITH CALCICOAT CERAMIC COATING

K980711 · Zimmer, Inc. · LPH · Nov 12, 1998 · Orthopedic

Device Facts

• Record ID: K980711
• Device Name: HARRIS/GALANTE POROUS (HGP) HIP PROSTHESIS WITH CALCICOAT CERAMIC COATING
• Applicant: Zimmer, Inc.
• Product Code: LPH · Orthopedic
• Decision Date: Nov 12, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3358
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Harris/Galante Hip Prosthesis is designed for implantation into the human joint in total hip or hemi-hip replacement and is indicated for the following: Total Hip Replacement: Severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, nonunion of previous fractures of the femur; congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis; disability due to previous fusion; previously failed endoprostheses, and/or total hip components in the affected extremity and acute femoral neck fractures. Hemi-Hip Replacement: Fracture dislocation of the hip; elderly, debilitated patients when a total hip replacement is contraindicated: irreducible fractures in which adequate fixation cannot be obtained; certain high subcapital fractures and comminuted femoral neck fractures in the aged; nonunion of femoral neck fractures; secondary avascular necrosis of the femoral head; pathological fractures of the femoral neck; and osteoarthritis in which the femoral head is primarily affected.

Device Story

Modular hip prosthesis system for total or hemi-hip replacement; consists of femoral stem, femoral head, acetabular component, and liner. Stem manufactured from Tivanium (Ti-6Al-4V alloy) with titanium fiber pads for bone ingrowth; proximal third coated with plasma-sprayed hydroxyapatite/tricalcium phosphate (HA/TCP). Morse-type 6° taper connects stem to femoral head (22-32 mm diameters). Implanted by orthopedic surgeons in clinical/OR settings to provide biological fixation via bone ingrowth into porous surface. Device restores joint function, reduces pain, and improves mobility in patients with degenerative or traumatic hip conditions.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on design, material, and technological characteristics compared to legally marketed predicate devices. Bench testing only.

Technological Characteristics

Modular hip system; Tivanium (Ti-6Al-4V) alloy stem; titanium fiber pads (approx. 2 mm thick) for porous fixation; plasma-sprayed HA/TCP coating (20-50 microns) on proximal third. Morse 6° taper modular connection. Femoral heads 22-32 mm. Biologic fixation via bone ingrowth. Non-software device.

Indications for Use

Indicated for patients requiring total or hemi-hip replacement due to severe hip pain/disability from conditions including rheumatoid/osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis, nonunion of femoral fractures, congenital dysplasia, protrusio acetabuli, slipped capital femoral epiphysis, failed prior endoprostheses, or acute femoral neck fractures. Hemi-hip indicated for elderly/debilitated patients where total hip is contraindicated, irreducible fractures, or specific subcapital/comminuted fractures.

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

• Harris/Galante Porous Hip Prosthesis (K840643)
• TCP-Coated Porocoat AML Femoral Hip Prosthesis (K964650)
• HGP II Acetabular Stem (K921308)
• Inter-Op HA Porous Acetabular System (K972393)

Submission Summary (Full Text)

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K 980711

Image /page/0/Picture/1 description: The image shows the logo for Zimmer Biomet. The logo consists of a large, bold letter "Z" inside of a circle. Below the circle is the word "zimmer" in a sans-serif font. The logo is black and white.

NOV 1 2 1998

P.O. Box 708 Warsaw, IN 46581-0708 219 267-6131

# Summary of Safety and Effectiveness

#### Submitted By: .

Zimmer, Inc. P.O. Box 708 Warsaw, Indiana 46581-0708 219-267-6131

### Contact Person: .

Ruth Wood Senior Regulatory Affairs Associate Telephone: [phone] Telefax: 219/372-4605

#### Date: ●

February 23, 1998

#### Trade Name: .

Harris/Galante Porous Hip Prosthesis With HA/TCP Coating

### Common Name: .

Femoral Hip Prosthesis

#### Classification Name: .

- Hip Joint Metal/Polymer/Metal Semiconstrained Porous-Coated Uncemented Prosthesis
## Stems:

- Harris/Galante Porous Hip Prosthesis, K-840643, cleared April 17, 1984 ♪
Image /page/0/Picture/20 description: The image shows a hexagon that is divided into six equilateral triangles. Each of the six triangles is further divided into three smaller triangles. The smaller triangles are arranged in a way that creates a three-dimensional effect, making it appear as if the triangles are folded or layered on top of each other. The overall design is symmetrical and geometric.

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- TCP-Coated Porocoat AML Femoral Hip Prosthesis, K-964650, cleared ♪ June 6, 1997
# Acetabular Cups:

- HGP II Acetabular Stem, K-921308, cleared February 22, 1994 ♪
- Inter-Op HA Porous Acetabular System, K-972393, cleared ♪ September 19, 1997

## Device Description

The hydroxyapatite tricalcium phosphate coated HGP Total Hip System is modular in design and consists of four basic components: The hip stem, the femoral head, the acetabular component and the liner. The Acetabular Components also have an HA/TCP coating.

The HGP Total Hip is a femoral component made from Tivanium® Ti-6A1-4V Alloy. The femoral stem is straight and similar to that of other conventional total hip stems. In addition, commercially pure titanium fiber pads of approximately 2 mm thickness are metallurgically bonded to the anterior, posterior, lateral and medial aspects of the stem body.

The proximal one-third of the stem is coated with HA/TCP which is applied by a plasma spraying process. This coating is approximately 20 to 50 microns in thickness. The plasma spray feedstock and resultant coating consists predominantly of calcium hydroxyapatite with minor components of betatricalcium phosphate and other calcium phosphates.

The modular connection of the femoral stem is a Morse type 6° taper designed to mate with the corresponding 6° bore of a femoral head component. The femoral heads are available in 22, 26, 28, and 32 mm diameters. The modular nature of the system allows for the use of a variety of neck lengths, offsets, and femoral head diameters. The devices may also be used with endoprostheses.

This ceramic is colorless. The measurement of a calcium phosphate ceramic's chemical composition involves determination of the calcium/phosphorus ratio and trace metals content by elemental analysis. The distribution among different crystalline phases is determined by powder X-ray diffraction, which has an accuracy of approximately 10 percent for any given phase in a multiphasic, moderately crystalline calcium phosphate ceramic.

The device is designed to fit the upper end of the femur and provide an

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interference fit with intimate contact between the porous titànium pads and the surrounding bone. This fibrous titanium mesh HA/TCP sufface has a porous morphology which provides a scaffold-like structure into which biological tissues may ingrow, thus fixing or anchoring the prosthesis.

## Intended Use/Indications

Total Hip Replacement:

Severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, nonunion of previous fractures of the femur; congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis: disability due to previous fusion: previously failed endoprostheses, and/or total hip components in the affected extremity and acute femoral neck fractures.

### Hemi-Hip Replacement:

Fracture dislocation of the hip; elderly, debilitated patients when a total hip replacement is contraindicated; irreducible fractures in which adequate fixation cannot be obtained; certain high subcapital fractures and comminuted femoral neck fractures in the aged; nonunion of femoral neck fractures; secondary avascular necrosis of the femoral head; pathological fractures of the femoral neck; and osteoarthritis in which the femoral head is primarily affected.

### Comparison to Predicate Devices

All hip systems listed above are substantially equivalent to each other and the HGP Hip Prosthesis in that each is intended for cementless fixation into the intramedullary canal for pathological or degenerative conditions involving the . femur and/or acetabulum. All predicate devices feature a porous or roughened surface and are modular in design. Each has a Morse-type proximal neck taper that mates with a femoral head which, in turn, articulates upon the ultra-high molecular-weight polyethylene (UHMWPE) bearing surface of a total hip or hemi-hip acetabular component. All predicate devices and the HGP Hip Prosthesis are manufactured from metal alloys that have a history of successful clinical use in orthopaedic applications.

#### Clinical and Nonclinical Data .

The HGP Hip Prosthesis is an example of a device designed to achieve biologic fixation to bone through bone ingrowth.

RA12702K.510

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Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" in a circular arrangement. The logo is simple and recognizable, conveying the department's authority and purpose.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 2 1998

لال ا

Toni R. Kingsley, Ph.D. Director, Regulatory Affairs Zimmer, Inc. P.O. Box 708 Warsaw, Indiana 46581-0708

Re: K980711 Harris/Galante Hip System with Calicoat® Ceramic Coating Requlatory Class: II Product Codes: LPH and MEH Dated: Auqust 19, 1998 Received: Auqust 21, 1998

Dear Dr. Kingsley:

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, Druq, 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 reqistration, listing of devices, qood manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

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Page 2 - Toni R. Kingsley, Ph.D.

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 Requlation (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. 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 obliqation 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 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 requlation (21 CFR Part 801 and additionally 809.10 for in yitro diaqnostic 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 requlation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be

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Page 3 - Toni R. Kingsley, Ph.D.

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. Cole M. Witten, Ph.D., M.

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

Enclosure

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# Exhibit V

## Indications for Use

Page _ 1_ of __ 1_

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Harris/Galante Porous Hip Prosthesis with HA/TCP Coating

Indications for Use:

The Harris/Galante Hip Prosthesis is designed for implantation into the human joint in total hip or hemi-hip replacement and is indicated for the following:

Total Hip Replacement:

Severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, nonunion of previous fractures of the femur; congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis; disability due to previous fusion; previously failed endoprostheses, and/or total hip components in the affected extremity and acute femoral neck fractures.

Hemi-Hip Replacement:

Fracture dislocation of the hip; elderly, debilitated patients when a total hip replacement is contraindicated: irreducible fractures in which adequate fixation cannot be obtained; certain high subcapital fractures and comminuted femoral neck fractures in the aged; nonunion of femoral neck fractures; secondary avascular necrosis of the femoral head; pathological fractures of the femoral neck; and osteoarthritis in which the femoral head is primarily affected.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _ + (Per 21 CFR 801.109)

RA12702K.510

OR

Over-The-Counter Use *_*_
(Optional Format 1-2-96)

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K980711