FOUNDATION POROUS HIP STEM

K991226 · Encore Orthopedics, Inc. · LZO · Jun 1, 1999 · Orthopedic

Device Facts

• Record ID: K991226
• Device Name: FOUNDATION POROUS HIP STEM
• Applicant: Encore Orthopedics, Inc.
• Product Code: LZO · Orthopedic
• Decision Date: Jun 1, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3353
• 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. Fabricated from wrought/forged Ti-6Al-4V alloy; surface features porous coating of commercially pure titanium beads. Device includes Morse-type taper for modular head attachment; available with or without calcar collar. Implanted by orthopedic surgeons in clinical/hospital settings to replace diseased or fractured hip joints. Provides structural support and fixation to femur; facilitates joint function restoration. Substantial equivalence based on identical geometry, materials, and indications to predicate devices.

Clinical Evidence

Bench testing only; finite element analysis performed.

Technological Characteristics

Material: Wrought/forged Ti-6Al-4V (ASTM F136) with commercially pure titanium (ASTM F67 grade 2) porous bead coating. Design: Cementless hip stem with Morse-type taper for modular heads; optional calcar collar. Energy source: N/A (mechanical implant).

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 treatments, or nonunion/fractures of the proximal femur with head involvement. Intended for cementless use.

Regulatory Classification

Identification

A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.

Submission Summary (Full Text)

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## Summary of Safety and Effectiveness

Encore Orthopedics, Inc. Debbie De Los Santos 9800 Metric Blvd. Austin, TX 78758 [phone]

Trade Name: Foundation® Porous Hip Stem - Size 8mm

Common Name: Cementless hip stem

Classification Name: Hip joint metal/polymer/metal semi-constrained porous coated uncemented prosthesis per 21 CFR 888.3358

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 geometry, is manufactured from the same material, and has the same indications as the predicate devices.

Test Results: Testing on this device included finite element analysis.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 1 1993

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

Re: K991226 Foundation Porous Coated Hip Stem - Size 8mm Trade Name: Regulatory Class: II Product Codes: LZO and LPH Dated: April 9, 1999 Received: April 12, 1999

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 of the Act. 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.

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 Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory 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 labelinq 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.qov/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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510(k) Number (if known): Device Name: _ Faradation Porsus Hip Stem - Size 8 m

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.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _X (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)_

Acolleto

(Division Sign-Off)
Division of General Restorative Devices K991226
510(k) Number