ENCORE HIP STEMS WITH CERAMIC HEADS AND UHMWPE LINERS

K082398 · Encore Medical L.P. · LZO · Oct 15, 2008 · Orthopedic

Device Facts

• Record ID: K082398
• Device Name: ENCORE HIP STEMS WITH CERAMIC HEADS AND UHMWPE LINERS
• Applicant: Encore Medical L.P.
• Product Code: LZO · Orthopedic
• Decision Date: Oct 15, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3353
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

DJO Surgical hip devices are intended for treatment of patients who are candidates for total hip arthroplasty per the indications for use. While hip replacements are not intended to withstand activity levels and loads of normal healthy bone, they are a means of restoring mobility and reducing pain for many patients.

Device Story

DJO Surgical hip systems (Vitality, Keystone, ALFA II, R120, R120PC) are orthopedic implants for total or partial hip arthroplasty. Modification involves adding a ceramic femoral head to existing hip stem designs. Implants are used by orthopedic surgeons in clinical settings to replace damaged hip joints, restore mobility, and reduce pain in patients with degenerative joint disease, arthritis, or fractures. Vitality and Keystone are designed for cementless application; ALFA II, R120, and R120PC support both cemented and cementless applications. The device functions as a mechanical prosthesis; it does not involve software or algorithms.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by bench testing demonstrating the device's ability to perform under expected clinical conditions.

Technological Characteristics

Hip joint prosthesis (metal/ceramic/polymer). Components include hip stems and ceramic femoral heads. Designed for cemented or cementless application depending on model. Materials are consistent with legally marketed predicate devices. No software or electronic components.

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. Applicable to total and partial hip replacement.

Regulatory Classification

Identification

A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.

Predicate Devices

• Foundation Hip Stem (K955563)

Reference Devices

• Vitality Hip Stem (K962560)
• Keystone Modular Hip Stem (K000521)
• ALFA II (Omega II Modular Total Hip System) (K984227)
• R120 (R120 Modular Total Hip System) (K011774)
• R120 PC (R120 Modular Total Hip System) (K021822)

Submission Summary (Full Text)

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| OCT 1 5 2008 | KO82398 #111<br>Summary of Safety and Effectiveness |
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| No of Canada Comments of Children Comparison Comparison Comparison Comparis Comparis Comparis Comparis Comparis Comparis Comparis Comparis Comparis Comparis Comparis Comparis | |

Date: September 22, 2008

Manufacturer: DJO Surgical (legally Encore Medical, L.P.) 9800 Metric Blvd Austin, TX 78758

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

| Product | 510(k) Number, Clearance Date/<br>Classification | Product Code |
|---------------------------------------------|--------------------------------------------------|--------------|
| Vitality Hip Stem | K962560 - September 19, 1996 / Class II | JDI |
| Keystone Modular Hip Stem | K000521 - May 10, 2000 / Class II | LPH |
| ALFA II (Omega II Modular Total Hip System) | K984227 - November 24, 1998 / Class II | JDI |
| R120 (R120 Modular Total Hip System) | K011774 – September 5, 2001 / Class II | JDI |
| R120 PC (R120 Modular Total Hip System) | K021822 - July 23, 2002 / Class II | JDI |

| Product Code | Regulation and Classification Name |
|--------------|-----------------------------------------------------------------------------------------------------------------------|
| JDI | Hip joint metal/polymer semi-constrained cemented prosthesis per 21 CFR 888.3350 |
| LPH | Hip joint metal/polymer/metal semi-constrained porous coated uncemented prosthesis per 21 CFR<br>888.3358 |
| LZO | Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.<br>per 2 I CFR 888.3353 |

The modification consists of use of a ceramic femoral head with the hip stem. The material used in the Description: ceramic femoral head is the same as other legally marketed predicate devices.

. ne Vitality, Keystone, Alfa II, R120 and R120PC are all designed for total hip joint replacement.

Total and partial hip 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.

The Vitality and Keystone are designed for a cementless application while the Alfa II, R120, and R120PC are designed for either cemented or cementless applications.

Intended Use: DJO Surgical hip devices are intended for treatment of patients who are candidates for total hip arthroplasty per the indications for use. While hip replacements are not intended to withstand activity levels and loads of normal healthy bone, they are a means of restoring mobility and reducing pain for many patients.

Predicate Device: Foundation Hip Stem - K955563

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

on-Clinical Testing: Mechanical testing has demonstrated the device's ability to perform under expected clinical conditions.

Clinical Testing: None provided.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The symbol is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is in all caps and appears to be in a sans-serif font.

Public Health Service

OCT 1 5 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K082398

Trade/Device Name: Vitality, Keystone Modular, ALFA II, R120, R120PC Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Regulatory Class: II Product Code: LZO, JDI, LPH Dated: September 22, 2008 Received: September 23, 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 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

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Page 2 - Ms. Teffany Hutto

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.

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 Compliation 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 yours.

Mark N. Millman

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): ____________________________________________________________________________________________________________________________________________________

K082398

Device Name: Vitality, Keystone Modular, Alfa II, R120, R120PC

Indications for Use:

## Indications for Use

Total and partial hip replacement is indicated for patients suffering from disability due to:

- noninflammatory degenerative joint diseasc 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 Vitality and Keystone are designed for a cementless application while the Alfa II, R120, and R120PC are designed for either cemented or cementless applications.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Division Sign-Off Division of General, Restorative, and Neurological Devices

510(k) Number K082398

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