VITALITY HIP SYSTEM MODEL#420

K070050 · Encore Medical L.P. · LPH · May 23, 2007 · Orthopedic

Device Facts

• Record ID: K070050
• Device Name: VITALITY HIP SYSTEM MODEL#420
• Applicant: Encore Medical L.P.
• Product Code: LPH · Orthopedic
• Decision Date: May 23, 2007
• Decision: SESE
• Submission Type: Traditional
• 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 . This device may also be indicated in the salvage of previously failed surgical attempts. The Encore hip systems are for total hip replacement except for the bipolar or unipolar hip systems which are for hemi-arthroplasty applications. The CLP Offset, CLP-R, and Stamina hip systems are for either total or hemi-applications.

Device Story

Encore Medical Hip System consists of various modular hip prostheses (stems, cups, liners, heads) for total hip replacement or hemi-arthroplasty. Modification involves updating Instructions for Use (IFU) to consolidate documentation and reflect current clinical practice. Devices are implanted by orthopedic surgeons in clinical/hospital settings. System includes cementless, cemented, and dual-application options. Output is a restored hip joint function. Benefits include relief of disability from degenerative disease, arthritis, or fracture. No changes to device design, materials, or manufacturing processes.

Clinical Evidence

No clinical data provided; this is a labeling-only modification.

Technological Characteristics

Prosthetic hip system components including femoral stems, acetabular cups, liners, and heads. Materials include metal, polymer, and ceramic combinations. Fixation methods include cemented and cementless (porous-coated) options. Design features are identical to 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. Applicable for total hip replacement or hemi-arthroplasty depending on specific system configuration. 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

• CLP I (Q System 28 Hip Stem) & CLP-R (K910010)
• All Poly Acetabular Cup (K934169, K942611)
• Foundation Cemented Hip Stem (K935449)
• Bipolar (K953510)
• Vitality Hip Stem (K962560)
• Foundation Press-Fit Hip Stem & CoCr Femoral Heads (K973302)
• Unipolar with Modular Neck Length Sleeves (K973614)
• Revelation Hip Stem (K973685)
• Foundation Fracture Hip Stem (K973809)
• FMP Acetabular Shells (K974093, K974095, K973119)
• Lincar Hip Stem (K974294)
• Stamina Hip Stem (K980473)
• Keystone Modular Hip Stem (K000521)
• ALFA II (Omega II Modular Total Hip System) & Modular Femoral Neck (K000817)
• R120 (R120 Modular Total Hip System) (K011774)
• R120 PC (R120 Modular Total Hip System) (K021822)
• FMP Constrained Acetabular Liners (K023794)

Submission Summary (Full Text)

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# Summary of Safety and Effectiveness

Date: April 18, 2007

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

Contact Person: Teffany Hutto Regulatory Affairs Specialist Phone: [phone] Fax: [phone] Email: Teffany [e-mail]

| Product | 510(k) Number, Clearance Date, Classification | Product Code |
|-----------------------------------------------------------------------|-------------------------------------------------------------------|---------------|
| CLP I (Q System 28 Hip Stem) & CLP-R | K910010 – March 12, 1991<br>Class II | LWJ |
| All Poly Acetabular Cup | K934169 – May 3, 1994<br>K942611 – September 28, 1994<br>Class II | JDI |
| Foundation Cemented Hip Stem | K935449 – March 30, 1995<br>Class II | JDI |
| Bipolar | K953510 – August 9, 1995<br>Class II | KWY |
| Vitality Hip Stem | K962560 – September 19, 1996<br>Class II | JDI |
| Foundation Press-Fit Hip Stem & CoCr Femoral Heads | K973302 – December 2, 1997<br>Class II | LPH, LZO |
| Unipolar with Modular Neck Length Sleeves | K973614 – December 18, 1997<br>Class II | KWI |
| Revelation Hip Stem | K973685 – December 19, 1997<br>Class II | LPH |
| Foundation Fracture Hip Stem | K973809 – January 2, 1998<br>Class II | LWJ |
| FMP Acetabular Shells (Spiked, Hemispherical, and Flared) | K974093, K974095, and K973119 –<br>January 28, 1998<br>Class II | LPH |
| Lincar Hip Stem | K974294 – January 12, 1998<br>Class II | LPH, LZO |
| Stamina Hip Stem | K980473 – April 16, 1998<br>Class II | LZO, LWJ, KWY |
| Keystone Modular Hip Stem | K000521 – May 10, 2000<br>Class II | LPH |
| ALFA II (Omega II Modular Total Hip System) & Modular<br>Femoral Neck | K000817 – June 8, 2000<br>Class II | JDI, LPH |
| R120 (R120 Modular Total Hip System) | K011774 – September 5, 2001<br>Class II | JDI, LPH |
| R120 PC (R120 Modular Total Hip System) | K021822 – July 23, 2002<br>Class II | JDI, LPH |
| FMP Constrained Acetabular Liners | K023794 – April 1, 2003<br>Class II | KWZ |

| Product Code | Regulation and Classification Name |
|--------------|-------------------------------------------------------------------------------------------------------------------|
| LWJ | Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis per 21 CFR 888.3360 |
| JDI | Hip joint metal/polymer semi-constrained cemented prosthesis per 21 CFR 888.3350 |
| KWY | Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis per 21 CFR 888.3390 |
| LPH | Hip joint metal/polymer/metal semi-constrained porous coated uncemented prosthesis per 21 CFR 888.3358 |
| LZO | Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis, per 21 CFR 888.3353 |
| KWL | Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis per 21 CFR 888.3360 |
| KWZ | Hip joint metal/polymer constrained cemented or uncemented prosthesis per 21 CFR 888.3310 |

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### Summary of Safety and Effectiveness - cont. Encore Medical - Hip System IFU

The modification consists of a change to the Instructions for Use for the devices Description: listed above to minimize the necessity for multiple IFU's and to update the contents to reflect current practice.

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 .

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

The Encore hip systems are for total hip replacement except for the bipolar or unipolar hip systems which are for hemi-arthroplasty applications. The CLP Offset, CLP-R, and Stamina hip systems are for either total or hemi-applications.

The following Hip Systems are for Cementless application:

| Linear | Stamina |
|----------------------|---------------------|
| Foundation Press-Fit | CLP Offset |
| Keystone Modular | CLP I |
| Revelation | Foundation Fracture |

The following hip systems are for cemented application: Foundation Cemented Vitality

The following hip systems are for either cementless applications: CLP R Alpha II R120 PC R120

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

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The logo is presented in black and white, giving it a formal and official appearance.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## MAY 2 3 2007

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

Re: K070050

Trade/Device Name: Encore Medical Hip System IFU Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: Class II Product Code: LPH, LWJ, LZO, JDI, KWY, KWL, KWZ Dated: April 18, 2007 Received: May 9, 2007

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 application (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 such 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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

barbare Rouchup

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

Enclosure

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# Indications for Use

510(k) Number (if known): ___K070050

Device Name: Encore Medical Hip System IFU

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 natural femoral . head;
- rheumatoid arthritis; .
- correction of functional deformity;

(Part 21 CFR 801 Subpart D)

- femoral fracture .
This device may also be indicated in the salvage of previously failed surgical attempts.

The Encore hip systems are for total hip replacement except for the bipolar or unipolar hip systems which are for hemiarthroplasty applications. The CLP Offset, CLP-R, and Stamina hip systems are for either total or hemi-applications.

| The following Hip Systems are for Cementless application: | | | |
|-------------------------------------------------------------------------------|---------------------|------------------|----------------------|
| Linear | Stamina | Keystone Modular | Revelation |
| Foundation Press-Fit | CLP Offset | CLP I | Foundation Fracture |
| The following hip systems are for cemented application: | | | |
| Vitality | Foundation Cemented | | |
| The following hip systems are for either cemented or cementless applications: | | | |
| Alpha II | CLP R | R120 | R120PC |
| Prescription Use | X | AND/OR | Over-The-Counter Use |

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

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

Jubacebneupforma
Division Sign-Off

Restorative, and Neurological Devices

Page 1 of 1

(21 CFR 801 Subpart C)

(Posted November 13, 2003)

510(k) Number.