ORTHO DEVELOPMENT CERAMIC FEMORAL HEADS WITH PRES-FIT STEMS

K053587 · Ortho Development Corp. · LZO · Mar 17, 2006 · Orthopedic

Device Facts

• Record ID: K053587
• Device Name: ORTHO DEVELOPMENT CERAMIC FEMORAL HEADS WITH PRES-FIT STEMS
• Applicant: Ortho Development Corp.
• Product Code: LZO · Orthopedic
• Decision Date: Mar 17, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3353
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The device is intended for use with an uncemented press-fit femoral stem. The device is intended for use in hip arthroplasty applications whose indications include: 1. Notably impaired hip joint due to osteoarthritis, rheumatoid arthritis, post traumatic arthritis, protrusion acetabuli and painful hip dysplasia. 2. Previously failed surgery. 3. Proximal femoral neck fractures or dislocation. 4. Idiopathic avascular necrosis of the femoral head. 5. Non-union of proximal femoral neck fractures. 6. Treatment of fractures that are unmanageable using other forms of therapy. 7. Benign or malignant bone tumors, congenital dysplasia or other structural abnormalities where sufficient bone stock exists to properly seat the prosthesis.

Device Story

Ceramic femoral head prosthesis designed for use with uncemented press-fit femoral stems in hip arthroplasty. Implanted by orthopedic surgeons in clinical/OR settings to replace damaged femoral head. Restores hip joint function; alleviates pain associated with arthritis, necrosis, or fractures. Provides structural support for patients with sufficient bone stock. Device serves as mechanical replacement component within total hip arthroplasty system.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Ceramic femoral head component; intended for use with uncemented press-fit femoral stems. Class II device (21 CFR 888.3353).

Indications for Use

Indicated for patients requiring hip arthroplasty due to osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, protrusion acetabuli, painful hip dysplasia, failed prior surgery, proximal femoral neck fractures/dislocation, idiopathic avascular necrosis, non-union of femoral neck fractures, or bone tumors/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.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

1414 17 2008

Ortho Development Corporation c/o Mr. William J. Griffin Regulatory and Clinical Affairs Manager 12187 South Business Park Drive Draper, Utah 84020

Re: K053587

Trade/Device Name: Ortho Development Ceramic Femoral Heads with Press-fit Stems 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: March 1, 2006 Received: March 2, 2006

Dear Mr. Griffin:

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 interstatc 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, FIJA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination docs 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 – Mr. William J. Griffin

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 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/dsma/dsmamain.html

Sincerely yours,

Herbert Semmel

Mark N. Melkerson Acting 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): | K053587 |
|---------------------------|--------------------------------------------------------------|
| Device Name: | Ortho Development Ceramic Femoral Heads with Press-fit Stems |

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Indications for Use

The device is intended for use with an uncemented press-fit femoral stem. The device is intended for use in hip arthroplasty applications whose indications include:

- 1. Notably impaired hip joint due to osteoarthritis, rheumatoid arthritis, post traumatic arthritis, protrusion acetabuli and painful hip dysplasia.
- 2. Previously failed surgery.
- Proximal femoral neck fractures or dislocation. 3.
- 4. Idiopathic avascular necrosis of the femoral head.
- 5. Non-union of proximal femoral neck fractures.
- 6. Treatment of fractures that are unmanageable using other forms of therapy.
- 7. Benign or malignant bone tumors, congenital dysplasia or other structural abnormalities where sufficient bone stock exists to properly seat the prosthesis.

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (Part 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)

(Division Si-Off)
Division of Ceneral, Restorative,
and Neurological Devices

510(k) Number k053581