PORTLAND COBALT CHROME FEMORAL HEAD

K063278 · Portland Orthopaedics Limited · JDI · Jan 12, 2007 · Orthopedic

Device Facts

• Record ID: K063278
• Device Name: PORTLAND COBALT CHROME FEMORAL HEAD
• Applicant: Portland Orthopaedics Limited
• Product Code: JDI · Orthopedic
• Decision Date: Jan 12, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3350
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Portland Cobalt Chrome 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 Cobalt Chrome Femoral Head is a single-component metal prosthesis; manufactured from cobalt chrome alloy; designed for use in hip arthroplasty. Device features internal 12/14 taper lock for connection to Portland Orthopaedics femoral hip stems; provides articulation with acetabular modules. Used by orthopedic surgeons in clinical/surgical settings. Device restores hip joint function; alleviates pain; improves mobility in patients with degenerative, traumatic, or revision-related hip conditions.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Cobalt chrome alloy femoral head; 12/14 taper lock interface; various sizes available; mechanical component for hip arthroplasty.

Indications for Use

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

Regulatory Classification

Identification

A hip joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).

Submission Summary (Full Text)

{0}------------------------------------------------

\$\qquad 063278\$

# SECTION 1

JAN 1 2 2007

# 510(K) SUMMARY

# SUBMITTED FOR:

| Company Name: | Portland Orthopaedics Limited |
|-------------------------|------------------------------------------------------------------------------------------|
| Address: | Unit 3, 44 McCauley St<br>Matraville, NSW, 2036 Australia |
| Telephone: | + 61-2-9666-8444 |
| Fax: | + 61-2-9666-8544 |
| SUBMITTED BY: | Elaine Duncan, M.S.M.E., RAC<br>President, Paladin Medical, Inc. |
| Address: | Paladin Medical, Inc.<br>PO Box 560<br>Stillwater, MN 55082,<br>United States of America |
| Telephone: | [phone] |
| Fax: | [phone] |
| CONTACT PERSON: | Elaine Duncan |
| DATE PREPARED: | October 25, 2006 |
| TRADE NAME: | Portland Cobalt Chrome Femoral Head |
| COMMON NAME: | Metal Femoral Head Prosthesis |
| DEVICE PROCODE & PANEL: | Orthopaedics 87 JDI, LWJ, LPH |
| REGULATION: | CFR § 888.3358, Class II |

#### DESCRIPTION of the DEVICE:

The Portland Cobalt Chrome Femoral Head is provided as a single component. The device is manufactured from a cobalt chrome alloy and is available in various sizes. The internal bore of the femoral head is designed to taper lock (12/14) with the external male taper on a Portland Orthopaedics femoral hip stem providing articulation with a suitable acetabular module.

#### INDICATIONS FOR USE:

510(k) Portland Orthopaedics, Ltd.

{1}------------------------------------------------

#### Page 2: 510(k) Summary

The Portland Cobalt Chrome 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.

### SUBSTANTIAL EQUIVALENCE INFORMATION

The Portland Cobalt Chrome Femoral Head described in this submission is substantially equivalent to cobalt chrome femoral heads manufactured by Biomet and Exacted, based on similarities of design, intended use, material and manufacturing meth 173x40As demonstrated by the test results and materials information, the differences in the Portland Cobalt Chrome Femoral Head do not raise any new issues of safety and effective roris.

#### SUMMARY of TESTING:

Portland Orthopaedics, Ltd. has provided analytical and mechanical testing to demonstrate the substantial equivalence of and compliance to standards for the Cobalt Chrome Femoral Head.

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

JAN 1 2 2007

Re: K063278

Trade/Device Name: Portland Cobalt Chrome Femoral Head Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer semi-constrained porous-coated uncemented prosthesis Regulatory Class: II Product Code: JDI, LPH, MEH Dated: October 25, 2006 Received: October 31, 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.

{3}------------------------------------------------

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.

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.

Barbary Muchm
tor

Mark N. M lelkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

# Indications for Use

510(k) Number (if known):

Device Name: Portland Cobalt Chrome Femoral Head

The Portland Cobalt Chrome 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.

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

Division of General, Restorative, and Neurological Devices

510(k) Number K063278

12 :