ACCOLADE TMZF PLUS HA 127 SIZE 0 HIP STEM

K023102 · Howmedica Osteonics Corp. · MEH · Oct 9, 2002 · Orthopedic

Device Facts

• Record ID: K023102
• Device Name: ACCOLADE TMZF PLUS HA 127 SIZE 0 HIP STEM
• Applicant: Howmedica Osteonics Corp.
• Product Code: MEH · Orthopedic
• Decision Date: Oct 9, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3353
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The subject hip stem is a single-use device intended for use in total hip replacement. It is intended for the reconstruction of the head and neck of the femoral joint. This hip stem is intended for primary reconstruction of the proximal femur or revision total hip arthroplasty. This device is intended for use with any currently available Howmedica Osteonics acetabular component and V40™ femoral heads that can be mated with a TMZF 5° 40' BG trunnion.

Device Story

Accolade™ TMZF® Plus HA 127° Size 0 Hip Stem is a line extension to the existing Accolade™ Hip System; designed for smaller patient populations. Device is a femoral component for total hip replacement; used in primary reconstruction of proximal femur or revision arthroplasty. Manufactured from TMZF® alloy; coated with CP Titanium plasma spray and PureFix™ HA. Operates as a cementless prosthesis; mates with Howmedica Osteonics acetabular components and V40™ femoral heads via a 5° 40' BG trunnion. Implanted by orthopedic surgeons in a clinical/hospital setting. Provides structural reconstruction of the femoral head and neck; restores joint function; benefits patients by addressing degenerative disease or fracture-related instability.

Clinical Evidence

Bench testing only. Testing evaluated the structural integrity and strength requirements of the Size 0 hip stem component.

Technological Characteristics

Material: TMZF® alloy; Coatings: CP Titanium plasma spray and PureFix™ HA. Design: Femoral stem with 127° neck angle, Size 0. Principle: Cementless, semi-constrained hip prosthesis. Connectivity: None (mechanical implant). Sterilization: Not specified.

Indications for Use

Indicated for cementless primary hip surgery in patients with non-inflammatory degenerative joint disease (osteoarthritis, avascular necrosis, rheumatoid arthritis, functional deformity); treatment of nonunion, femoral neck, and trochanteric fractures of the proximal femur with head involvement; and revision procedures where other treatments failed.

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

• Accolade™ TMZF® Plus HA Hip Stem

Submission Summary (Full Text)

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OCT 0 9 2002

K02 3/02

Line Extension to the Accolade™ Hip System – Accolade™ TMZF® Plus HA 127° Size 0 Hip Stem

Special 510(k) Premarket Notification

## Special 510(k) Summary

# Line Extension to the Accolade™ Hip System – Accolade™ TMZF® PLUS HA 127° Size 0 Hip Stem

| Proprietary Name: | Accolade™ TMZF® Plus HA 127° Size 0 Hip<br>Stem |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Artificial Hip Component |
| Classification Name and Reference: | Hip joint, metal/ceramic/polymer semi-constrained<br>cemented or nonporous uncemented prosthesis,<br>21 CFR §888.3353 |
| Proposed Regulatory Class: | Class II |
| Device Product Code: | 87 MEH |
| Predicate Proprietary Name: | Accolade™ TMZF® Plus HA Hip Stem |
| Predicate Regulatory Class: | Class II |
| Predicate Product Code: | 87 MEH |
| For Information contact: | Debra Bing<br>Howmedica Osteonics Corp.<br>59 Route 17<br>Allendale, New Jersey 07401-1677<br>Phone: [phone]<br>Fax: [phone] |

### Description/Technological Comparison

The existing Accolade™ TMZF® HA Hip System features femoral stems in neutral, press-fit versions consisting of a variety of lengths and two neck angles, 132° and 127°. The subject Accolade™ TMZF® Plus HA 127° Size 0 Hip Stem is an addition to the existing hip stems. It features a 127° neck angle and will be offered in an additional size (size 0). The Accolade™ TMZF® Plus HA Size 0 Hip Stem is intended for smaller size patient populations. The subject

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hip stem, like the predicate hip stems, is manufactured using TMZF® alloy and is also coated with a CP Titanium plasma spray coating and PureFix™ HA.

#### Intended Use

The subject hip stem is a single-use device intended for use in total hip replacement. It is intended for the reconstruction of the head and neck of the femoral joint. This hip stem is intended for primary reconstruction of the proximal femur or revision total hip arthroplasty. This device is intended for use with any currently available Howmedica Osteonics acetabular component and V40™ femoral heads that can be mated with a TMZF 5° 40' BG trunnion.

#### Indications:

- Cementless primary hip surgery in cases of non-inflammatory degenerative joint disease . including osteoarthritis, avascular necrosis, rheumatoid arthritis, and correction of functional deformity.
- Treatment of nonunion, and femoral neck and trochanteric fractures of the proximal femur ● with head involvement that are unmanageable using other techniques.
- Revision procedures where other treatments or devices have failed. ●

#### Testing Summary

Testing was employed to evaluate the Accolade™ TMZF® Plus HA Size 0 Hip Stem component. Testing demonstrated that this hip stem component successfully maintains the proper strength requirements.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

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# OCT 0 9 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. William J. Cymbaluk Vice President . Quality Assurance, Regulatory Affairs and Clinical Research Stryker Howmedica Osteonics 59 Route 17 South Allendale, N.J. 07401

Re: K023102

Trade/Device Name: Accolade™ TMZF® Plus HA 127° Size 0 Hip Sem 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: MEH Dated: September 17, 2002 Received: September 18, 2002

Dear Mr. Cymbaluk:

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 (OS) 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. William J. Cymbaluk

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,

Hyatt Rhodes

Celia M. Witten, Ph.D., M.D. 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: Line Extension to the Accolade™ Hip System - Accolade™ TMZF® Plus 127° Size 0 Hip Stem

The subject hip stem is a single-use device intended for use in total hip replacement. It is intended for the reconstruction of the head and neck of the femoral joint. This hip stem is intended for primary reconstruction of the proximal femur or revision total hip arthroplasty. This device is intended for use with any currently available Howmedica Osteonics acetabular component and V40™ femoral heads that can be mated with a TMZF 5° 40' BG trunnion.

#### Indications:

- Cementless primary hip surgery in cases of non-inflammatory degenerative joint disease including . osteoarthritis, avascular necrosis, rheumatoid arthritis, and correction of functional deformity.
- Treatment of nonunion, and femoral neck and trochanteric fractures of the proximal femur with . head involvement that are unmanageable using other techniques.
- Revision procedures where other treatments or devices have failed. .

## (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

OR
Over-The-Counter Use
(Optional Format 1-2-96)
(Per 21 CFR 801.109)

(Division Sign-Off)
Division of General. Restorative
and Neurological Devices
510(k) Number K023102