FOUNDATION POROUS HIP STEM

K973302 · Encore Orthopedics, Inc. · LPH · Dec 2, 1997 · Orthopedic

Device Facts

• Record ID: K973302
• Device Name: FOUNDATION POROUS HIP STEM
• Applicant: Encore Orthopedics, Inc.
• Product Code: LPH · Orthopedic
• Decision Date: Dec 2, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3358
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Foundation® Porous Hip Stem is intended for treatment of patients who are candidates for total hip arthroplasty because of degenerative joint disease including osteoarthritis and avascular necrosis; rheumatoid arthritis; correction of functional deformity; revision procedures where other treatments or devices have failed: : and treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement, which is unmanageable using other techniques. It is intended to be used in a cementless mode.

Device Story

Foundation® Porous Hip Stem is a cementless femoral component for total hip arthroplasty. Device features a wrought/forged Ti-6Al-4V stem with a porous coating of commercially pure titanium beads; includes Morse taper for modular head attachment; available with or without calcar collar. Used by orthopedic surgeons in clinical/surgical settings to replace diseased or fractured hip joints. Provides structural support for hip joint reconstruction; facilitates biological fixation via porous coating. Clinical benefit includes restoration of joint function and mobility in patients with degenerative disease or trauma.

Clinical Evidence

Bench testing only; specifically fatigue testing on the Morse type taper.

Technological Characteristics

Materials: Wrought/forged Ti-6Al-4V (ASTM F136) stem with porous commercially pure titanium (ASTM F67 grade 2) beads. Design: Cementless hip stem with Morse taper for modular heads; optional calcar collar. Energy source: None (mechanical).

Indications for Use

Indicated for patients requiring total hip arthroplasty due to degenerative joint disease (osteoarthritis, avascular necrosis), rheumatoid arthritis, functional deformity, revision of failed prior treatments, or nonunion/fractures of the proximal femur (femoral neck/trochanteric) with head involvement. Intended for cementless use.

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.

Submission Summary (Full Text)

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## Summary of Safety and Effectiveness

Encore Orthopedics, Inc. 9800 Metric Blvd. Austin, TX 78758 [phone]

BEC - 2 1997

## 1973302

Trade Name: Foundation® Porous Hip Stem

Common Name: Cementless hip stem

Classification Name: Hip joint metal/polymer semi-constrained prosthesis per 21 CFR 888.3350 and Hip joint Femoral (hemi-hip) metallic uncemented prosthesis per 21 CFR 888.3360

Description: The Foundation® Porous Hip Stem is fabricated from wrought/forged Ti-6A1-4V that conforms to ASTM F136. The outside surface of the stem is porous coated with commercially pure titanium (ASTM F67 grade 2) beads.

The Foundation® Porous Hip Stem is available with and without a calcar collar and has a Morse type taper to receive modular heads.

Intended Use: The Foundation® Porous Hip Stem is intended for treatment of patients who are candidates for total hip arthroplasty because of degenerative joint disease including osteoarthritis and avascular necrosis; rheumatoid arthritis; correction of functional deformity; revision procedures where other treatments or devices have failed: : and treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement, which is unmanageable using other techniques. It is intended to be used in a cementless mode.

Comparable Features to Predicate Device(s): The Foundation® Porous Hip Stem has the same geomety, is manufactured from the same material, and has the same indications as the predicate devices.

Test Results: Testing on this device included fatigue testing on the Morse type taper.

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Image /page/1/Picture/2 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 or bird with three heads, representing the department's mission to protect the health of all Americans. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird image.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 2 1997

Ms. Debbie De Los Santos Regulatory Clinical Specialist Encore Orthopedics 9800 Metric Boulevard Austin, Texas 78758

Re: K973302 Foundation® Porous Hip Stem Regulatory Class: II Product Codes: LPH and LZO Dated: September 2, 1997 Received: September 3, 1997

Dear Ms. De Los Santos:

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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਸੈ 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 regulation may result in regulatory In addition, FDA may publish further announcements action. 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 regulations.

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## Page 2 - Ms. Debbie De Los Santos

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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K973302

510(k) Number (if known): ___________________________________________________________________________________________________________________________________________________

Device Name: _

Indications For Use:

## Foundation® Porous Hip Stem Indications For Use

The indications for use of the Foundation® Porous total hip replacement prosthesis include: degenerative joint disease including osteoarthritis and avascular necrosis; rheumatoid arthritis; correction of functional deformity; revision procedures where other treatments or devices have failed; and treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement, which is unmanageable using other techniques. This stem is intended to be used in a cementless mode.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | |
|-----------------------------------------|---------|
| Division of General Restorative Devices | |
| 510(k) Number | K973302 |

| Prescription Use (per 21 CFR 801.109) | OR | Over-The-Counter Use |
|---------------------------------------|----|--------------------------|
| | | (Optional Format 1-2-96) |