PORTLAND CERAMIC (BIOLOX-FORTE) FEMORAL HEAD

K061564 · Portland Orthopaedics Pty. , Ltd. · LZO · Sep 1, 2006 · Orthopedic

Device Facts

• Record ID: K061564
• Device Name: PORTLAND CERAMIC (BIOLOX-FORTE) FEMORAL HEAD
• Applicant: Portland Orthopaedics Pty. , Ltd.
• Product Code: LZO · Orthopedic
• Decision Date: Sep 1, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3353
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Portland Ceramic (Biolox-Forte) Femoral Head has the following indications for use: The patient should be skeletally mature. The patient's condition should be due to one or more of the following: 1. Osteoarthritis. 2. Rheumatoid arthritis. 3. Tumor conditions involving the upper third of the femur or of the Acetabular. 4. Ankylosing spondylitis. 5. Psoriatic arthritis. 6. Old osteomyelitis with a long infection-free period and a normal WBC, ESR and C-reactive protein. 7. Non union of femoral neck fracture or avascular necrosis of the femoral head. 8. Post-traumatic fracture/dislocation of the hip. 9. Revision of an unsuccessful arthrodesis with either poor positioning or pain in the hip, or where low back pain or knee pain is becoming disabling. 10. Revision of an unsuccessful cemented or un-cemented hip replacement, providing sufficient bone stock is present. 11. Revision of a previous unsuccessful femoral osteotomy, Girdlestone resection, cup arthroplasty or hemi arthroplasty.

Device Story

Portland Ceramic (Biolox-Forte) Femoral Head is a single-component orthopedic prosthesis; manufactured from Alumina Oxide (Biolox-Forte). Device features 12/14 taper bore for connection to femoral hip stem; articulates with acetabular module. Used in surgical hip replacement/revision procedures; operated by orthopedic surgeons in clinical/hospital settings. Provides structural replacement for femoral head to restore hip joint function; benefits patients by addressing degenerative, inflammatory, or traumatic hip conditions.

Clinical Evidence

Bench testing only. Analytical and mechanical testing provided to demonstrate substantial equivalence and compliance with standards.

Technological Characteristics

Material: Alumina Oxide (Biolox-Forte). Design: Femoral head with 12/14 taper bore. Energy source: None (mechanical). Connectivity: None. Sterilization: Not specified.

Indications for Use

Indicated for skeletally mature patients requiring hip arthroplasty due to osteoarthritis, rheumatoid arthritis, tumor conditions of femur/acetabulum, ankylosing spondylitis, psoriatic arthritis, old osteomyelitis, non-union of femoral neck fracture, avascular necrosis, post-traumatic fracture/dislocation, or revision of prior unsuccessful hip procedures (arthrodesis, cemented/uncemented replacement, osteotomy, Girdlestone resection, cup arthroplasty, or hemiarthroplasty).

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.

Reference Devices

• DePuy ceramic femoral heads
• Exactech ceramic femoral heads
• Plus ceramic femoral heads

Submission Summary (Full Text)

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# K061564 (P9) of z

# 510(k) Summary

## SUBMITTED FOR:

| Company Name: | Portland Orthopaedics Limited | |
|-------------------------|----------------------------------------------|--|
| Address: | Unit 3, 44 McCauley St | |
| | Matraville, NSW, 2036 Australia | |
| Telephone: | + 61-2-9666-8444 | |
| Fax: | + 61-2-9666-8544 | |
| SUBMITTED BY: | Elaine Duncan, M.S.M.E., RAC | |
| | President, Paladin Medical, Inc. | |
| Address: | Paladin Medical, Inc. | |
| | PO Box 560 | |
| | Stillwater, MN 55082, | |
| | United States of America | |
| Telephone: | [phone] | |
| Fax: | [phone] | |
| CONTACT PERSON: | Elaine Duncan | |
| DATE PREPARED: | June 1, 2006 | |
| TRADE NAME: | Portland Ceramic (Biolox-Forte) Femoral Head | |
| COMMON NAME: | Ceramic Femoral Head Prosthesis | |
| DEVICE PROCODE & PANEL: | Orthopaedics 87 LZO | |

#### DESCRIPTION of the DEVICE:

REGULATION:

The Portland Portland Ceramic (Biolox-Forte) Femoral Head is provided as a single component. The device is manufactured from an Alumina Oxide (Biolox-Forte) and is available in various sizes. The internal bore of the femoral head is designed to taper look (12/14) with the external male taper on a femoral hip stem providing articulation with a suitable acetabular module.

CFR § 888.3354, Class II

#### INDICATIONS FOR USE:

The Portland Ceramic (Biolox-Forte) Femoral Head has the following indications for use:

- The patient should be skeletally mature.
- · The patient's condition should be due to one or more of the following:
- 1. Osteoarthritis.
- 2. Rheumatoid arthritis.

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### 510(k) Summary-Continued

- 3. Tumor conditions involving the upper third of the femur or of the Acetabular.
6061564

- 4. Ankylosing spondylitis.
- 5. Psoriatic arthritis.
- 6. Old osteomyelitis with a long infection-free period and a normal WBC, ESR and C-reactive protein.
- 7. Non union of femoral neck fracture or avascular necrosis of the femoral head.
- 8. Post-traumatic fracture/dislocation of the hip.
- 9. Revision of an unsuccessful arthrodesis with either poor positioning or pain in the hip, or where low back pain or knee pain is becoming disabling.
- 10. Revision of an unsuccessful cemented or un-cemented hip replacement, providing sufficient bone stock is present.
- 11. Revision of a previous unsuccessful femoral osteotomy, Girdlestone resection, cup arthroplasty or hemi arthroplasty.

## SUBSTANTIAL EQUIVALENCE INFORMATION

The Portland Portland Ceramic (Biolox-Forte) Femoral Head described in this submission is substantially equivalent to ceramic femoral heads manufactured by DePuy, Exactech and Plus, based on similarities of design, intended use, material and manufacturing methods. As demonstrated by the test results and material and the differences in the Portland Ceramic (Biolox-Forte) Femoral Head do not raise any new issues of safety and effectiveness.

### SUMMARY of TESTING:

Portland Orthopaedics, Ltd. has provided analytical and mechanical testing to demonstrate the substantial equivalence of and compliance to standards for the Ceramic (Biolox-Forte) Femoral Head.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three tail feathers, representing the department's commitment to health, human services, and well-being. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 1 2006

Portland Orthopaedics, Ltd. % Ms. Elaine Duncan, M.S.M.E., RAC President, Paladin Medical, Inc. P.O. Box 560 Stillwater, Minnesota 55082

Re: K061564

Trade/Device Name: Portland Ceramic (BIOLOX-Forte) Femoral Head Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Regulatory Class: Class II Product Code: LZO Dated: June 1, 2006 Received: June 5, 2006

Dear Ms. Duncan:

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. Elaine Duncan, M.S.M.E., RAC

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.

and the comments of the count

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,

Barbara Buchner
for

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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# Indications for Use

| 510(k) Number (if known): | K061564 |
|---------------------------|----------------------------------------------|
| Device Name: | Portland Ceramic (Biolox-Forte) Femoral Head |

The Portland Ceramic (Biolox-Forte) Femoral Head has the following indications for use:

• The patient should be skeletally mature.

· The patient's condition should be due to one or more of the following:

1. Osteoarthritis.

2. Rheumatoid arthritis.

3. Tumor conditions involving the upper third of the femur or of the Acetabular.

4. Ankylosing spondylitis.

5. Psoriatic arthritis.

6. Old osteomyelitis - with a long infection-free period and a normal WBC, ESR and Creactive protein.

7. Non union of femoral neck fracture or avascular necrosis of the femoral head.

8. Post-traumatic fracture/dislocation of the hip.

9. Revision of an unsuccessful arthrodesis with either poor positioning or pain in the hip, or where low back pain or knee pain is becoming disabling.

10. Revision of an unsuccessful cemented or un-cemented hip replacement, providing sufficient bone stock is present.

11. Revision of a previous unsuccessful femoral osteotomy, Girdlestone resection, cup arthroplasty or hemi arthroplasty.

Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)

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)

Page 1 of 1

Barbara huckins

Division of General, Restorative, and Neurological Devices

510(k) Number K061564