BIOLOX DELTA CERAMIC FEMORAL HEAD, BIOLOX DELTA CERAMIC FEMORAL HEAD OFFSET SLEEVE

K082844 · Encore Medical L.P. · LZO · Nov 25, 2008 · Orthopedic

Device Facts

• Record ID: K082844
• Device Name: BIOLOX DELTA CERAMIC FEMORAL HEAD, BIOLOX DELTA CERAMIC FEMORAL HEAD OFFSET SLEEVE
• Applicant: Encore Medical L.P.
• Product Code: LZO · Orthopedic
• Decision Date: Nov 25, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3353
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

Biolox delta Ceramic Femoral Head is a prosthetic hip component manufactured from alumina matrix composite. Device replaces natural femoral head in total hip arthroplasty. Standard version attaches to femoral stem via taper fit; Option version includes sleeve inserted into head, then attached to stem via taper fit. Available in 22, 28, 32, 36, 40, and 44mm sizes. Used by orthopedic surgeons in clinical settings to restore mobility and reduce pain in patients with hip joint disability. Device functions as load-bearing interface within hip prosthesis system.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by mechanical bench testing demonstrating device performance under expected clinical conditions.

Technological Characteristics

Material: Biolox delta (alumina matrix composite). Form factor: Femoral head (sizes 22-44mm) with optional taper-fit sleeve. Energy source: None (passive implant). 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, femoral fracture, or salvage of failed surgical attempts.

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

• Zimmer Biolox delta Ceramic Femoral Head (K071535)
• Biomet Biolox delta Ceramic Head (K042091, K051411, K061312)
• DePuy Delta Ceramic Femoral Head (K062748)
• Stryker Howmedica Osteonics V40 Biolox delta Ceramic Femoral Head (K052781)
• Stryker Howmedica Osteonics V40/C-Taper Adapter Sleeve (K003379)

Submission Summary (Full Text)

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K082844 (pg 1/1)

# Summary of Safety and Effectiveness

Date: September 25, 2008

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

NOV 2 5 2008 Contact Person: Teffany Hutto Manager, Regulatory Affairs Phone: [phone] Fax: [phone] Email: [e-mail]

| AND AREA AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND A<br>Product >>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>> | 510(k) Number Clearance Date/ Classification Product Code 200 | | Product Code | Regulation and Classification Name |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|------------------|--------------|---------------------------------------------------------------------------------------------------------------------|
| Biolox® Ceramic Femoral Head | K955563 - August 9, 1996 / Class I | 170<br>-1 ------ | LZO | Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis per<br>21 CFR 888.3353 |
| | | | | |

Description: The modification consists of a new material used in the manufacture of the Biolox Ceramic Femoral Heads. The femoral heads, manufactured from Biolox® delta* material, are fabricated from an alumina matrix composite. The standard femoral head with a femoral stem through a taper fit. The Option femoral head includes a sleeve that is inserted into the head and attached to the femoral stem through a taper fit. The heads will be available in sizes 22, 28, 32, 36, 40 and 44mm.

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.

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 Devices:

- · Zimmer Biolox® delta Ceramic Femoral Head K071535, Cleared November 19, 2007
- · Biomet Biolox delta Ceramic Head K042091, Cleared March 25, 2005, K051411, Cleared June 29, 2005, K061312, Cleared June 6, 2006
- · DePuy Delta Ceramic Femoral Head K062748, Cleared November 30, 2006
- · Stryker Howmedica Osteonics V40™ Biolox delta Ceramic Femoral Head K052781, Cleared October 27, 2005
- · Stryker Howmedica Osteonics V40™/C-Taper Adapter Sleeve -- K003379, Cleared November 30, 2000

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

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

Clinical Testing: None provided.

*Trademark of CeramTec AG

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## NOV 2 5 2008

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

Re: K082844

Trade/Device Name: Biolox delta Ceramic Femoral Head Biolox delta Ceramic Femoral Head Offset Sleeve 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 Dated: October 30, 2008 Received: October 31, 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

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Page 2 - Ms. Teffany Hutto

CFR Part 807); labeling (21 CFR Part 801); good manufacturing practicc 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. 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 yours.

Mark A. Mulhausen

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): _ KOB2844 Lpg \/1)

Device Name: Ceramic Femoral Head

Indications for Use:

### Biolox® delta Ceramic Femoral Head 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; �
- . femoral fracture

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

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)

Mark A. Milken

(Division Sign-Off) (Division Sign-Onal, Restorative, Division of or orices 510(k) Number