REVELATION POROUS HIP STEM

K973685 · Encore Orthopedics, Inc. · LPH · Dec 19, 1997 · Orthopedic

Device Facts

• Record ID: K973685
• Device Name: REVELATION POROUS HIP STEM
• Applicant: Encore Orthopedics, Inc.
• Product Code: LPH · Orthopedic
• Decision Date: Dec 19, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3358
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Revelation™ 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.

Device Story

The Revelation™ Porous Hip Stem is a cementless femoral component for total hip arthroplasty. Fabricated from Ti-6Al-4V alloy, the stem features a porous coating of commercially pure titanium beads to facilitate biological fixation. The device is collarless and incorporates a Morse-type taper to accommodate modular femoral heads. It is intended for surgical implantation by orthopedic surgeons in a hospital setting to replace the femoral head and neck in patients with degenerative joint disease, rheumatoid arthritis, or proximal femoral fractures. By providing a stable, porous-coated interface for bone ingrowth, the device aims to restore joint function and alleviate pain associated with hip pathology. Clinical benefit is derived from the restoration of hip biomechanics and long-term fixation within the femoral canal.

Clinical Evidence

Bench testing only; fatigue testing performed on the Morse-type taper.

Technological Characteristics

Material: Ti-6Al-4V (ASTM F136/F1108); Porous coating: Commercially pure titanium beads (ASTM F67 grade 2). Design: Collarless, cementless hip stem with Morse-type taper for modular heads.

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 involving the femoral head.

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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K973685

DEC 19 1997

## Summary of Safety and Effectiveness

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

Revelation™ Porous Hip Stem Trade Name:

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

The Revelation™ Porous Hip Stem is fabricated from wrought/forged or cast Ti-Description: 6A1-4V that conforms to ASTM F136 or F1108, respectively. The outside surface of the stem is porous coated with commercially pure titanium (ASTM F67 grade 2) beads to provide a porous surface for enhanced fixation.

The Revelation™ Porous Hip Stem is collarless and has a Morse type taper to receive modular heads.

Intended Use: The Revelation™ 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.

Comparable Features to Predicate Device(s): The Revelation™ 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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 19 1997

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

Re: K973685 Revelation Porous Hip Stem Regulatory Class: II Product Code: LPH Dated: December 5, 1997 December 9, 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). 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. ਜ 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,

Cel ia 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:

Indications For Use:

## Revelation™ Porous Hip Stem Indications For Use

The indications for use of the Revelation™ 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.

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

Concurrence of CDRH. Office of Device Evaluation (ODE)

P. Ciallella

12973685

Prescription Use (per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)