TRIDENT II ACETABULAR SYSTEM

K063616 · Howmedica Osteonics Corp. · LZO · Dec 20, 2006 · Orthopedic

Device Facts

• Record ID: K063616
• Device Name: TRIDENT II ACETABULAR SYSTEM
• Applicant: Howmedica Osteonics Corp.
• Product Code: LZO · Orthopedic
• Decision Date: Dec 20, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3353
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Trident® II Acetabular Shells described in this 510(k) submission are single-use sterile devices intended for cementless fixation within the prepared acetabulum. They are compatible with Trident® II X3® Polyethylene bearing inserts, which are also the subject of this submission. If additional fixation is desired, the dome screw holes, if present, have been designed to accept Howmedica Osteonics 6.5mm or 5.5mm bone screws. The Trident® II Acetabular Shells described in this 510(k) submission are single-use sterile devices intended for cementless fixation with the mating Trident® II X36 Polyethylene Inserts.

Device Story

Trident® II Acetabular System; single-use sterile acetabular shells for cementless hip arthroplasty; modification of locking mechanism from predicate Trident Acetabular System; compatible with Trident® II X3® Polyethylene inserts; optional use of 5.5mm or 6.5mm bone screws for additional fixation; implanted by orthopedic surgeons in clinical/hospital settings; provides stable acetabular component for hip joint reconstruction; benefits patients by restoring joint function and reducing pain associated with degenerative or traumatic hip disease.

Clinical Evidence

Bench testing only; no clinical data provided. Mechanical testing demonstrated comparable mechanical properties to predicate components.

Technological Characteristics

Cementless acetabular shell; metal/ceramic/polymer construction; compatible with X3® Polyethylene inserts; optional dome screw holes for 5.5mm/6.5mm bone screws; sterile, single-use; mechanical locking mechanism.

Indications for Use

Indicated for patients with painful, disabling hip joint disease (degenerative, rheumatoid, or post-traumatic arthritis; late-stage avascular necrosis); revision of unsuccessful femoral head replacement, cup arthroplasty, or other procedures; clinical management where arthrodesis or alternative techniques are less likely to succeed; or cases with poor bone stock/acetabular deficiencies.

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

• Trident Acetabular System (K063616)

Submission Summary (Full Text)

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K0636/6

### Summary of Safety and Effectiveness Trident® II Acetabular System

DEC 2 0 2006

Proprietary Name:

Common Name:

Classification Name:

Regulation Number:

Device Product Code:

For Information Contact:

Trident® II Acetabular System

Artificial Hip Replacement Components -Acetabular

Hip joint metal/ceramic/polymer semiconstrained cemented or nonporous uncemented prosthesis

21 CFR §888.3353

LZO, MEH

Manal Morcos, Regulatory Affairs Specialist Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 Phone: [phone] Fax: [phone]

Date Summary Prepared:

October 10, 2006

#### Description:

This Special 510(k) submission is intended to add the Trident® II Acetabular System. This system is a minor modification to the locking mechanism of the predicate Trident Acetabular System.

#### Intended Use:

The Trident® II Acetabular Shells described in this 510(k) submission are single-use sterile devices intended for cementless fixation within the prepared acetabulum. They are compatible with Trident® II X3® Polyethylene bearing inserts, which are also the subject of this submission. If additional fixation is desired, the dome screw holes, if present, have . been designed to accept Howmedica Osteonics 6.5mm or 5.5mm bone screws.

The Trident® II Acetabular Shells described in this 510(k) submission are single-use sterile devices intended for cementless fixation with the mating Trident® II X36 Polyethylene Inserts.

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### Indications for Use:

- · Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis.
- · Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
- · Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
- Where bone stock is of poor quality or inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum.

## Substantial Equivalence:

The subject Trident® II Acetabular System shares the same intended use, materials, and basic design concepts as that of the currently available acetabular components of the Trident® Acetabular System. Mechanical testing demonstrated comparable mechanical properties to the predicate components and substantial equivalence to these devices.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle-like symbol with flowing lines, representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" is arranged in a circular pattern around the symbol. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Howmedica Osteonics Corp. % Mr. Manal Morcos Regulatory Affairs Specialist 325 Corporate Drive Mahwah. New Jersey 07430

DEC 2 0 2006

Re: K063616

Trade/Device Name: Trident® II Acetabular System 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: December 4, 2006 Received: December 5, 2006

Dear Mr. Morcos:

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 - Mr. Manal Morcos

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,

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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#### 510(k) Number (if known):

# Device Name: Trident® II Acetabular System

The subject Trident® II Acetabular Shells are intended for cementless fixation within the prepared acetabulum. The subject Acetabular shells intended for use with mating Trident® II X3® Polyethylene Inserts.

Indications for Use:

- · Painful, disabling joint disease of the hip resulting from: degenerative arthritis. rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis.
- · Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
- · Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
- · Where bone stock is of poor quality or inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum,

Prescription Use X Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

120123616 510(k) Number_