ORTHO DEVLOPMENT CERAMIC FEMORAL HEAD

K111936 · Ortho Development · LZO · Sep 21, 2011 · Orthopedic

Device Facts

• Record ID: K111936
• Device Name: ORTHO DEVLOPMENT CERAMIC FEMORAL HEAD
• Applicant: Ortho Development
• Product Code: LZO · Orthopedic
• Decision Date: Sep 21, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3353
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Ortho Development Biolox Delta Ceramic Femoral Head is inteded for use in total hip arthroplasty procedures with the Ovation Hip Stem System (indicated for uncemented, biological fixation of the stem) and the Encompass Hip Stem System (indicated for both cemented and uncemented, biological fixation of the stem). Total hip arthroplasty is indicated for the following conditions: - Notably impaired hip joints due to osteoarthritis, rheumatoid arthritis and/or post traumatic arthritis. - Previously failed hip surgery. - Fractures of the femoral neck or head. - Avascular necrosis of the femoral head. - Congenital dysplasia or other structural abnormalities where sufficient bone stock exists to properly seat the prosthesis.

Device Story

Biolox Delta ceramic femoral head; mates with Ovation and Encompass 12/14 taper femoral hip stems; articulates against polyethylene acetabular liners. Used in total hip arthroplasty procedures. Available in 28mm, 32mm, and 40mm diameters with various offsets. Implanted by orthopedic surgeons in clinical settings to restore hip joint function in patients with degenerative or traumatic joint conditions.

Clinical Evidence

Bench testing only. No clinical data provided. Mechanical performance validated through burst fracture, taper disassemble (pull-off), and wear tests.

Technological Characteristics

Biolox Delta ceramic material; 12/14 taper interface; 28mm, 32mm, and 40mm diameters. Mechanical fixation via taper fit. Class II device per 21 CFR 888.3353.

Indications for Use

Indicated for patients undergoing total hip arthroplasty due to osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, failed prior hip surgery, femoral neck/head fractures, avascular necrosis, or congenital dysplasia/structural abnormalities with sufficient bone stock.

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

• Ortho Development Ceramic Femoral Head with Press-fit Stems (K053587)
• Ortho Development Ceramic Femoral Head (K060577)
• Smith & Nephew Biolox Delta Ceramic Femoral Heads (K083762)

Submission Summary (Full Text)

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## 2011

| | Summary of Safety and Effectiveness | |
|--|-------------------------------------|--|
| | | |

| NAME OF SPONSOR: | Ortho Development Corporation |
|----------------------|-------------------------------------------------------------------------------|
| | 12187 South Business Park Drive |
| | Draper, Utah 84020 |
| 510(k) CONTACT: | Tom Haueter |
| | Regulatory Affairs Manager |
| | Telephone: [phone] |
| | Facsimile: [phone] |
| | Email: [e-mail] |
| DATE PREPARED: | Date: June 13, 2011 |
| PROPRIETARY NAME: | Ortho Development Biolox Delta Ceramic Femoral Heads |
| COMMON NAME: | Femoral head |
| CLASSIFICATION: | 21 CFR 888.3353, Hip joint metal/ceramic/polymer semi-constrained cemented or |
| | nonporous uncemented prosthesis; Class II device |
| DEVICE PRODUCT CODE: | LZO |
| PREDICATE DEVICES: | Ortho Development Ceramic Femoral Head with Press-fit Stems |
| | Ortho Development Corp. |
| | (K053587) |
| | |
| | Ortho Development Ceramic Femoral Head |
| | Ortho Development Corp. |
| | (K060577) |
| | |
| | Smith & Nephew Biolox Delta Ceramic Femoral Heads |
| | Smith & Nephew, Inc. |
| | (K083762) |

### DEVICE DESCRIPTIONS:

The Ortho Development Biolox Delta Ceramic Femoral Heads mate with the existing Ortho Development Ovation and Encompass 12/14 taper femoral hip stems and articulate against Ortho Development polyethylene acetabular liners. The femoral heads are available in 28mm, 32mm, and 40mm diameters in a variety of offsets.

### INDICATIONS FOR USE:

The Ortho Development Biolox Delta Ceramic Femoral Head is inteded for use in total hip arthroplasty procedures with the Ovation Hip Stem System (indicated for uncemented, biological fixation of the Encompass Hip Stem System (indicated for both cemented and uncemented, biological fixation of the stem).

Total hip arthroplasty is indicated for the following conditions:

- Notably impaired hip joints due to osteoarthritis and/or post traumatic arthritis. 1.
- 2. Previously failed hip surgery.
- 3. Fractures of the femoral neck or head.
- 4. Avascular necrosis of the femoral head.
- 5. Congenital dysplasia or other structural abnormalities where sufficient bone stock exists to properly seat the prosthesis.

### BASIS OF SUBSTANTIAL EQUIVALENCE:

Ortho Development Biolox Delta Ceramic Femoral Heads are substantially equivalent to the previously cleared predicate devices based on similarities in intended use, design, materials, size range, manufacturing methods, packaging, sterilization method, and mechanical performance.

Mechanical testing data demonstrates that the Ortho Development Biolox Delta Ceramic Femoral Heads are equivalent to currently marketed devices and able to withstand expected in vivo loading. This is demonstrated in burst fracture, taper disassemble (pull off) and wear tests as described in the Summary of Design Control Activities.

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is an image of an eagle with its wings spread, with three lines extending from the eagle's head.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Ortho Development Corporation % Mr. Tom Haueter Regulatory Affairs Manager 12187 South Business Park Drive Draper, Utah 84020

SEP 2 1 2011

Re: K111936

Trade/Device Name: Ortho Development Biolox Delta Ceramic Femoral Head Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prothesis Regulatory Class: Class II Product Code: LZO Dated: August 19, 2011 Received: August 22, 2011

Dear Mr. Haueter :

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. Ilisting 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Mr. Tom Haueter

forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.lda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Eric Keith

C' Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indication for Use Form Ortho Development Biolox Delta Ceramic Femoral Head 510(k)

510(k) Number (if known): K111936

Device Name: Ortho Development Biolox Delta Ceramic Femoral Head

Indications for Use:

The Ortho Development Biolox Delta Ceramic Femoral Head is inteded for use in total hip arthroplasty procedures with the Ovation Hip Stem System (indicated for uncemented, biological fixation of the stem) and the Encompass Hip Stem System (indicated for both cemented and uncemented, biological fixation of the stem).

Total hip arthroplasty is indicated for the following conditions:

- Notably impaired hip joints due to osteoarthritis, rheumatoid arthritis and/or post l . traumatic arthritis.
- 2. Previously failed hip surgery.
- Fractures of the femoral neck or head. 3.
- Avascular necrosis of the femoral head. 4.
- Congenital dysplasia or other structural abnormalities where sufficient bone stock ട്. exists to properly seat the prosthesis.

| Prescription Use<br>(Part 21 CFR 801 Subpart D) | X | AND/OR |
|-------------------------------------------------|---|--------|
|-------------------------------------------------|---|--------|

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

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

Michael Owens for MXM

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K111936