EQUATOR PLUS ACETABULAR CUP SYSTEM

K051844 · Portland Orthopaedics Pty. , Ltd. · MAY · Oct 7, 2005 · Orthopedic

Device Facts

• Record ID: K051844
• Device Name: EQUATOR PLUS ACETABULAR CUP SYSTEM
• Applicant: Portland Orthopaedics Pty. , Ltd.
• Product Code: MAY · Orthopedic
• Decision Date: Oct 7, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3353
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Equator Plus™ Acetabular Cup System 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

The Equator Plus™ Acetabular Cup System is a modular total hip replacement component for cementless application. It consists of a titanium alloy (Ti-6Al-4V) coated outer shell and a pre-assembled ultra-high molecular weight polyethylene (UHMWPE) liner force-fitted into a cobalt-chrome metal dome casing. The device is implanted by a surgeon during hip arthroplasty to replace the acetabular surface. It functions as a mechanical bearing surface to restore hip joint function and mobility in patients with degenerative or traumatic hip conditions. The system is designed for use as part of a modular hip replacement construct.

Clinical Evidence

Bench testing only.

Technological Characteristics

Modular acetabular cup system; materials include titanium alloy (Ti-6Al-4V) outer shell, UHMWPE liner, and cobalt-chrome metal dome casing. Designed for cementless application. No software or electronic components.

Indications for Use

Indicated for skeletally mature patients requiring total hip replacement due to osteoarthritis, rheumatoid arthritis, tumor conditions of the upper femur/acetabulum, ankylosing spondylitis, psoriatic arthritis, old osteomyelitis, non-union of 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/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

• Margron Hip Replacement System (K032641)

Submission Summary (Full Text)

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OCT 7 - 2005

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### 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<br>President, Paladin Medical, Inc.<br>PO Box 560<br>Stillwater, MN 55082 | |
| Telephone: | 715-549-6035 | |
| Fax: | 715-549-5380 | |
| CONTACT PERSON: | Elaine Duncan | |
| DATE PREPARED: | July 5, 2005, revised September 26, 2005 | |
| TRADE NAME: | Equator Plus™ Acetabular Cup System | |
| COMMON NAME: | Acetabular Cup System | |
| DEVICE PROCODE & PANEL: | : JDI, LWJ, MAY Orthopaedics 87 | |

### DESCRIPTION of the DEVICE:

The Equator Plus™ Acetabular Cup System is comprised of two units the first is a coated outer shell manufactured from titanium alloy (Ti-6A1-4V). The second unit is a ultra high molecular weight polyethylene (UHMWPE) liner force fitted into an outer cobalt chrome metal dome casing. The UHMWPE liner is provided as a single pre-assembled component. The Equator Plus™ Acetabular Cup System is to be used as part of a modulary total hip replacement system in a cementless application.

## SUBSTANTIAL EQUIVALENCE INFORMATION

The Equator Plus™ Acetabular Cup System described in this submission is substantially equivalent to the predicate devices in the same classification and procode designation. Testing and materials qualification have demonstrated that the differences in the Equator Plus ™ Acetabular Cup System do not raise any new issues of safety and effectiveness. The Equator Plus™ Acetabular Cup System has been qualified for use with the Margron Hip Replacement System (cleared under K032641).

### INDICATIONS FOR USE:

The Equator Plus™ Acetabular Cup System 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.

- 4. Ankylosing spondylitis.
- 5. Psoriatic arthritis.
- 5. I sollatie urnifitib.
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.

## SUMMARY of TESTING:

SUMMANT of TED III. has provided analytical and mechanical testing to r orthand Orthopactics, Ltd. Has proved and compliance to standards for the Equator Plus™ Acetabular Cup System.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS) in the United States. The logo features the department's name encircling a stylized symbol. The symbol consists of three abstract human figures, representing the department's focus on health and well-being. The text is arranged in a circular fashion around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 7 - 2005

Portland Orthopaedics Limited c/o Ms. Elaine Duncan, M.S.M.E., RAC President Paladin Medical, Inc. P.O. Box 560 Stillwater, Minnesota 55082

Re: K051844

Trade/Device Name: The Equator Plus™ Acetabular Cup System 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: MAY, JDI, LWJ Dated: September 26, 2005 Received: September 27, 2005

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.

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.

Mark Miller

C Mark 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): ____________________________________________________________________________________________________________________________________________________

Equator Plus™ Acetabular Cup System Device Name:

The Equator Plus™ Acetabular Cup System 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.

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

Over-The-Counter Use No (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 Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number_k o 51844