ENCORE LINEAR POROUS COATED HIP

K974294 · Encore Orthopedics, Inc. · LPH · Jan 12, 1998 · Orthopedic

Device Facts

• Record ID: K974294
• Device Name: ENCORE LINEAR POROUS COATED HIP
• Applicant: Encore Orthopedics, Inc.
• Product Code: LPH · Orthopedic
• Decision Date: Jan 12, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3358
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Linear™ Porous Coated Hip Stem is intended for treatment of patients who are candidates for total hip arthroplasty because the natural femoral head and neck have been affected by osteoarthritis, inflammatory arthritis, traumatic arthritis, rheumatoid arthritis, avascular necrosis or femoral neck fracture, and revision arthroplasty where bone loss is minimal.

Device Story

Cementless hip stem prosthesis; intended for press-fit implantation during total hip arthroplasty. Device features wrought/forged Ti-6Al-4V substrate with commercially pure titanium porous coating for enhanced fixation. Geometry includes rectangular cross-section for rotational stability, 6° proximal flare, and 135° stem/neck angle. Modular design accommodates standard and lateralized head/stem offsets via Morse type taper. Used by orthopedic surgeons in clinical/hospital settings to replace diseased or fractured femoral head/neck. Benefits include restoration of joint function and stability in patients with arthritis or femoral fractures.

Clinical Evidence

Bench testing only. Laboratory testing conducted on fatigue stem strength and Morse type taper.

Technological Characteristics

Material: Wrought/forged Ti-6Al-4V (ASTM F136/F620) with commercially pure titanium porous coating (ASTM F67 grade 2). Design: Collarless, rectangular cross-section, 6° proximal flare, 135° stem/neck angle. Fixation: Press-fit. Connectivity: None. Sterilization: Not specified.

Indications for Use

Indicated for patients requiring total hip arthroplasty due to noninflammatory degenerative joint disease (osteoarthritis, avascular necrosis), rheumatoid arthritis, functional deformity, failed prior treatments/devices, or proximal femur fractures (femoral neck/trochanteric) with head involvement unmanageable by other techniques.

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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JAN 1 2 1998 K974294

Encore Orthopedics®, Inc. 9800 Metric Blvd Austin, TX 78758 512-832-9500

Trade Name: Linear™ Porous Coated Hip Stem

Common Name: Cementless hip stem

Classification Name: Hip joint metal/polymer/metal semi-constrained porous coated uncemented prosthesis

## Description

When viewed in the mediolateral plane the Linear™ Porous Coated Hip Stem tapers slightly proximal to distal beginning at the distal border of the porous coating. Proximal to this point the stem flares approximately 6°. The stem has a rectangular cross-sectional geometry to provide rotational stability

The Linear™ Porous Coated Hip Stem is fabricated from wrought/forged Ti-6Al-4V that conforms to ASTM F136 or F620, respectively. The outside surface of the stem is porous coated with commercially pure titanium (ASTM F67 grade 2) to provide a porous surface for enhanced fixation The stem is intended to be press-fit.

The Linear™ Porous Coated Hip Stem is collarless and has a Morse type taper to receive modular heads. This stem is available with a standard head/stem offset and a lateralized version that provides additional lateralization of the patient's femur without increasing leg length. The stem/neck angle is 135°.

Intended Use: The Linear™ Porous Coated Hip Stem is intended for treatment of patients who are candidates for total hip arthroplasty because the natural femoral head and neck have been affected by osteoarthritis, inflammatory arthritis, traumatic arthritis, rheumatoid arthritis, avascular necrosis or femoral neck fracture, and revision arthroplasty where bone loss is minimal.

Comparable Features to Predicate Device(s): Features comparable to predicate devices include Ti-6Al-4V substrate, straight stem, symmetric, no collar, narrow slightly taper stem in lateral view, and modular heads.

Test Results: Laboratory testing of the fatigue stem strength and Morse type taper was conducted.

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Image /page/1/Picture/2 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined strands. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the caduceus. The seal is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

IAN 12 1998

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

Re: K974294 Linear™ Porous Coated Hip Stem Trade Name: Requlatory Class: II Product Codes: LPH and LZO Dated: November 12, 1997 Received: November 14, 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 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 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 requlations.

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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,

f 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):

Linear™ Porous Coated Hip Stem Device Name:

Indications For Use:

## Linear™ Porous Coated Hip Stem Indications For Use

The indications for use of the total hip replacement prosthesis include: noninflammatory 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 to be press-fit.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(per 21 CFR 801.109)