TIGRAN HIP PROSTHESIS

K984492 · Ponmed , Ltd. · LPH · Mar 15, 1999 · Orthopedic

Device Facts

• Record ID: K984492
• Device Name: TIGRAN HIP PROSTHESIS
• Applicant: Ponmed , Ltd.
• Product Code: LPH · Orthopedic
• Decision Date: Mar 15, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3358
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Tigran TM Hip Prosthesis for total hip arthoplasty consists of three basic parts: femoral heads, femoral stems, and the instrumentation necessary for proper implantation of these components. The Tigran TM Hip Prosthesis is designed for implantation into the human femur in total or hip replacement and is indicated for the following: 1) Patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur 2) Patients with congenital hip dysplasia, protrusion acetabuli, or slipped capital femoral epiphysis; 3) Patients suffering from disability due to previous fusion; 4) Patients with previously failed endoprostheses and/or total hip components in the affected extremity: 5) Patients with acute femoral neck fractures.

Device Story

Tigran Hip Prosthesis is a modular, cementless femoral hip system for total hip arthroplasty. Components include a Titanium Ti-6Al-4V alloy femoral stem with a rectangular cross-section and surface finish for rotational stability/fixation, and a Cobalt-Chromium-Molybdenum alloy femoral head (28mm diameter). The system utilizes a Morse-type tapered neck for modular assembly. Instrumentation is provided for implantation. Used by orthopedic surgeons in clinical settings to replace diseased or damaged hip joints. The device provides a stable articulating surface when paired with a compatible UHMWP acetabular component. Benefits include pain relief and restoration of hip function for patients with degenerative or traumatic hip conditions.

Clinical Evidence

Long-term clinical testing was performed to demonstrate safety and performance. No specific metrics or study results were provided in the summary document.

Technological Characteristics

Materials: Titanium Ti-6Al-4V alloy (femoral stem), Cobalt-Chromium-Molybdenum alloy (femoral head). Design: Modular, cementless, straight femoral stem with rectangular cross-section, Morse-type tapered neck. Surface: Prepared finish for fixation. Compatibility: Designed for use with UHMWP acetabular components. Sterilization: Not specified.

Indications for Use

Indicated for patients with severe hip pain/disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis, nonunion of femoral fractures, congenital hip dysplasia, protrusion acetabuli, slipped capital femoral epiphysis, disability from previous fusion, failed endoprostheses/total hip components, or acute femoral neck 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

• Zimmer Versys Hip System (K964769)
• DePuy Stability Hip System (K915594)

Submission Summary (Full Text)

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-Ponmed Limited

Confidential

Tigran 510(k)

P981117

Date of current draft 226/99

Section 16.0 510(k) Summary

K984492

## 510K(k) SUMMARY

SUBMITTER:

Ponmed Limited

DATE PREPARED: November 17th, 1998 Tigran™ Hip Prosthesis DEVICE NAME: CLASSIFICATION NAME: Femoral Hip Prosthesis

PREDICATE DEVICES:

The Tigran TM Hip Prosthesis is substantially equivalent to the Zimmer Versys Hip System (510(k) Number K 964769) and the DePuy Stability™ Hip System (K 915594).

## Device Description:

The Tigran™ Femoral Prosthesis for hip arthroplasty consists of three basic parts: femoral heads, femoral stems, and the instrumentation necessary for proper implantation of these components. The femoral stem is made from Titanium Ti-6A1-4V Alloy, a high fatigue strength material with a long history of clinical use and exceptional The surface of the femoral stem is prepared with a surface finish and biocompatibility. pattern to provide optimal initial and lasting fixation in bone. The femoral stem has a collar and is modular in design, incorporating a Morse-type tapered neck and utilizing modular femoral heads. The Femoral stem is straight and with a rectangular crosssectional shape to provide optimal, rotational stability. The Tigran™ Prosthesis Femoral Stem is available in four neck sizes (short, medium, long and extra long).

The femoral head is fabricated from Cobalt-Chromium-Molybdenum Alloy and comes in three neck configurations (short, medium and long) and in one head diameter (28mm). The various neck lengths provided allow this prosthesis to fit different variations found in the human femora.

The titanium and chrome-cobalt alloy components can be used together, although they are made from dissimilar alloys. In vitro electrochemical corrosion studies have shown that no detrimental changes occur when the two alloys are coupled.

Special instruments are available to assist in mating, disassembling, and the accurate

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· Ponned Limited

| Confidential | Filename<br>Tigran 510(k) | File No.<br>P981112 | Date of current draft<br>2/26/99 |
|--------------|---------------------------|---------------------|----------------------------------|
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installation of the implant components.

The Tigran™ Femoral Prosthesis (femoral stem and head) may be used with any acetabular prosthesis with an articulating surface made of ultra high molecular weight polyethylene (UHMWP) and designed to be used with a 28 mm CoCrMo Alloy femoral head.

## Intended Use:

The Tigran TM Hip Prosthesis for total hip arthoplasty consists of three basic parts: femoral heads, femoral stems, and the instrumentation necessary for proper implantation of these components. The Tigran TM Hip Prosthesis is designed for implantation into the human femur in total or hip replacement and is indicated for the following:

- 1) Patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur
- 2) Patients with congenital hip dysplasia, protrusion acetabuli, or slipped capital femoral epiphysis;
- 3) Patients suffering from disability due to previous fusion;
- 4) Patients with previously failed endoprostheses and/or total hip components in the affected extremity:
- 5) Patients with acute femoral neck fractures.

This indication statement is essentially the same as the indication statement for the predicate device.

#### Comparison to Predicate Devices:

All hip systems listed in the previous table are substantially equivalent to each other and to the Tigran TM Hip Prosthesis which are 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. All incorporate pure titanium, a Titanium alloy, or hydroxy apetitie as a surface texture coating or interface for the femoral stem. Each has Morse-type proximal neck taper that mates with a femoral head which, in turn articulates upon the acetabular component. All predicate devices and the Tigran TM Hip Prosthesis are manufactured from metal alloys that have a history of successful clinical use in orthopedic applications.

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- Ponned Limited

| Confidential | Filename | File No. | Date of current draft |
|--------------|---------------|----------|-----------------------|
| | Tigran 510(k) | P981112 | 2/26/99 |

The Tigran ™ Hip Prosthesis is substantially equivalent to the Zimmer Versys Hip System (510(k) Number K 964769) and the DePuy Stability™ Hip System (K 915594).

Examination of the information pertaining to the Tigran ™ Hip Prosthesis demonstrates that this device is substantially equivalent in composition, intended use, packaging and labeling to other hip prostheses currently approved for commercial distribution in the United States by the FDA. There are no significant differences between these marketed products and our proposed device.

## Summary of Non-Clinical Tests:

Non-clinical mechanical testing was performed to demonstrate that the femoral stem met or exceed the appropriate testing standards / requirements

## Clinical Test Results:

Long-term clinical testing was performed and reported on to demonstrate the safety and performance of the Tigran™ Hip Prosthesis.

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Image /page/3/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. The bottom half of the circle contains a stylized image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 5 1999

Jeffrey R. Shideman, Ph.D. Ponmed Limited 7307 Glouchester Drive Edina, Minnesota 55435

Re: K984492 Tigran™ Hip Prosthesis Trade Name: Regulatory Class: II Product Codes: LPH and JDI Dated: November 17, 1998 December 17, 1998 Received:

#### Dear Dr. Shideman:

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.

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Page 2 - Jeffrey R. Shideman, Ph.D.

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,

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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**Page** / of /

#### 510 (k) NUMBER (IF KNOWN): K984492

DEVICE NAME: Tigran Hip Prosthesis

INDICATIONS FOR USE:

Indications for Use Statement

- 1) Patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur
- 2). Patients with congenital hip dysplasia, protrusion acetabuli, or slipped capital femoral epiphysis;
- 3) Patients suffering from disability due to previous fusion;
- 4) Patients with previously failed endoprostheses and/or total hip components in the affected extremity;
- 5) Patients with acute femoral neck fractures.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use 11/1 (Per 21 CFR 801.109)

OR

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

to coely

(Division Sign-Off)
Division of General Restorative Devices K984492
510(k) Number ***_*****_**