REVELATION HIP STEM, MODELS, 427-01, 427-02; LINEAR HIP STEM, MODELS 425-00, 425-05

K081679 · Encore Medical L.P. · LPH · Aug 20, 2008 · Orthopedic

Device Facts

• Record ID: K081679
• Device Name: REVELATION HIP STEM, MODELS, 427-01, 427-02; LINEAR HIP STEM, MODELS 425-00, 425-05
• Applicant: Encore Medical L.P.
• Product Code: LPH · Orthopedic
• Decision Date: Aug 20, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3358
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Joint replacement is indicated for patients suffering from disability due to: - noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis of the natural femoral head; - rheumatoid arthritis; - correction of functional deformity; - femoral fracture. These devices may also be indicated in the salvage of previously failed surgical attempts. Both the Revelation and Linear hip stems are designed for a cementless application.

Device Story

The Revelation and Lincar Hip Stems are orthopedic implants designed for cementless hip joint replacement. The modification involves an additional method of applying a porous coating to the existing hip stem designs. These devices are intended for surgical implantation by orthopedic surgeons in a hospital or clinical setting to restore joint function and alleviate disability caused by degenerative disease, arthritis, or fracture. The implants serve as structural replacements for the natural femoral head. Clinical benefit is derived from the restoration of hip joint mobility and stability.

Clinical Evidence

Bench testing only.

Technological Characteristics

Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis. The device utilizes a porous coating application method. Materials, design, and sterilization methods are consistent with previously cleared predicate devices.

Indications for Use

Indicated for patients with disability due to noninflammatory degenerative joint disease (osteoarthritis, avascular necrosis), rheumatoid arthritis, functional deformity, or femoral fracture. Also indicated for salvage of failed surgical attempts.

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.

Predicate Devices

• Revelation® Hip Stem (K973685)
• Lincar® Hip Stem (K974294)

Submission Summary (Full Text)

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## K081679 AUG 2 0 2008 Summary of Safety and Effectiveness

Date: August 4, 2008

Manufacturer . Encore Medical, I. P. 9800 Metric Blvd Austin, TX 78758

Contact Person: Teffany Hutto Manager, Regulatory Affairs Phone: [phone] Fax: {512} 834-6313 Email: [e-mail]

| Product | 510(k) Number, Clearance Date,<br>Classification | Product Code | Product Code | Regulation and Classification Name |
|----------------------|-------------------------------------------------------------------------------------------|---------------|--------------|-------------------------------------------------------------------------------------------------------------------|
| Revelation® Hip Stem | K973685 - December 19, 1997<br>Class II | LPH, KWZ | LPH | Hip joint metal/polymer/metal semi-constrained porous coated uncemented prosthesis per 21 CFR 888.3358 |
| Lincar® Hip Stem | K974294 - January 12, 1998<br>Class II | LPH, LZO, KWZ | LZO | Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis. per 21 CFR 888.3353 |
| KWZ | Hip joint metal/polymer constrained cemented or uncemented prosthesis per 21 CFR 888.3310 | | | |

The modification consists of an additional method of porous coating currently Description: conducted on the hip devices listed above.

Joint replacement is indicated for patients suffering from disability due to:

- noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis � of the natural femoral head;
- rheumatoid arthritis; 事
- correction of functional deformity; 心
- 心 femoral fracture

This device may also be indicated in the salvage of previously failed surgical atternots.

Both the Revelation and Linear hip stents are designed for a cementless application

Comparable Features to Predicate Device(s): Features comparable to predicate devices include the same materials, design, indications, packaging, and sterilization.

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Image /page/1/Picture/1 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 an abstract image of an eagle or other bird with outstretched wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 20 2008

Encore Medical, L.P. % Ms. Teffany Hutto Manager, Regulatory Affairs 9800 Metric Boulevard Austin, Texas 78758

Re: K081679 Trade/Device Name: Revelation® Hip Stem & Linear Hip Stem Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: II Product Code: LPH, LZO, KWZ Dated: August 4, 2008 Received: August 6, 2008

Dear Ms. Hutto:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval (PMA). 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 (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Teffany Hutto

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Mark N Millican

- Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure

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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Revelation® Hip Stem & Linear Hip Stem

Indications for Use:

## Revelation® Hip Stem & Linear Hip Stem Indications for Use

Joint replacement is indicated for patients suffering from disability due to:

- noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis of the 心 natural femoral head.
- rheamatoid arthritis; 事
- correction of functional deformity; t
- formorel fracture 章

These devices may also be indicated in the salvage of previously failed surgical attempts.

Both the Revelation and Linear hip steans are designed for a cementless application.

Preseription Use (Part 21 CFR 801 Subpart D)

ANDIOR

Over-The-Counter Use (2) CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Давлат Виссарионович Джорджика

Division of General, Restorative, and Neurological Devices

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**510(k) Number** *K081679*