ENCORE LINEAR HIP

K972791 · Encore Orthopedics, Inc. · JDI · Jan 12, 1998 · Orthopedic

Device Facts

• Record ID: K972791
• Device Name: ENCORE LINEAR HIP
• Applicant: Encore Orthopedics, Inc.
• Product Code: JDI · Orthopedic
• Decision Date: Jan 12, 1998
• Decision: SN
• Submission Type: Traditional
• Regulation: 21 CFR 888.3350
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Linear 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. It is intended to be used with bone cement.

Device Story

Linear Hip Stem is a cemented femoral component for total hip arthroplasty. Device features a wrought/forged Ti-6Al-4V substrate with a plasma-sprayed commercially pure titanium coating to enhance cement fixation. Design includes a rectangular cross-section for rotational stability, a 6° proximal flare, and a Morse-type taper for modular head attachment. Available in standard and lateralized offsets with a 135° neck angle. Used by orthopedic surgeons in clinical settings to replace diseased or fractured femoral heads/necks. The device provides a stable foundation for the prosthetic hip joint, aiming to restore function and reduce pain in patients with degenerative or traumatic hip conditions.

Clinical Evidence

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

Technological Characteristics

Material: Wrought/forged Ti-6Al-4V (ASTM F136) with plasma-sprayed commercially pure titanium (ASTM F67 grade 2) coating. Design: Collarless, rectangular cross-section, 6° proximal flare, 135° neck angle, Morse-type taper. Energy source: None (mechanical). 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, revision procedures, or proximal femur fractures (femoral neck/trochanteric) unmanageable by other techniques. Intended for use with bone cement.

Regulatory Classification

Identification

A hip joint metal/polymer semi-constrained cemented 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).

Submission Summary (Full Text)

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## Summary of Safety and Effectiveness

Encore Orthopedics®, Inc. 9800 Metric Blvd Austin, TX 78758 212-832-9500

JAN 1 2 1998

Trade Name: Linear™ Hip Stem

Common Name: Cemented hip stem

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

Description

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

The Linear™ Hip Stem is fabricated from wrought/forged Ti-6Al-4V that conforms to ASTM F136. The outside surface of the stem is plasma sprayed with commercially pure titanium (ASTM F67 grade 2) to provide a roughened surface for enhanced cement fixation

The Linear™ 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 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. It is intended to be used with bone cement.

Comparable Features to Predicate Device(s): Features comparable to predicate devices include Ti-6A1-4V substrate, straight stem, symmetric, no collar, narrow slightly taper stem in lateral view, modular heads and CP titanium plasma spray coating.

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

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Image /page/1/Picture/13 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its head turned to the right.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 2 1998

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

Re : K972791 Linear™ Hip System Trade Name: Requlatory Class: II Product Code: JDI Dated: October 28, 1997 October 30, 1997 Received:

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). This decision is based on this device being equivalent only to similar devices labeled and intended to be fixed within bone with acrylic "bone cement." You may, therefore, market your device subject to the general controls provisions of the Act and the following limitations:

- 1. This device may not be labeled or promoted for noncemented use.
- 2. All labeling for this device, including package label and labeling included within the package, must prominently state that the device is intended for -----------------------------------------cemented use only.

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

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Page 2 - Ms. Debbie De Los Santos

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 regulation may result in regulatory In addition, FDA may publish further announcements action. Please note: concerning your device in the Federal Register. 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.

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 gener 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,

a 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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12/30/87

510(k) Number (if known):

Device Name: ____Linear Hip Stem

Indications For Use:

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## Linear 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 intended to be used with cement.

(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 | K972791 |

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