ACCOLADE TMZF HA 132 DEGREE SIZE 0 HIP STEM

K020572 · Howmedica Osteonics Corp. · MEH · Mar 4, 2002 · Orthopedic

Device Facts

• Record ID: K020572
• Device Name: ACCOLADE TMZF HA 132 DEGREE SIZE 0 HIP STEM
• Applicant: Howmedica Osteonics Corp.
• Product Code: MEH · Orthopedic
• Decision Date: Mar 4, 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 5° 40' BG taper.

Device Story

Accolade™ TMZF® HA 132° Size 0 Hip Stem is a femoral component for total hip replacement; intended for smaller patient populations. Device functions as a structural implant for reconstruction of the femoral head and neck. Manufactured from TMZF® alloy with CP Titanium plasma spray coating and PureFix™ HA coating. Used in primary or revision hip arthroplasty; implanted by orthopedic surgeons in a clinical/OR setting. Device mates with Howmedica Osteonics acetabular components and V40™ femoral heads via 5° 40' BG taper. Provides mechanical stability for the proximal femur; restores joint function.

Clinical Evidence

Bench testing only. Analysis indicates the component maintains proper strength requirements.

Technological Characteristics

Material: TMZF® alloy; Coating: CP Titanium plasma spray and PureFix™ HA. Form factor: Femoral hip stem, Size 0, 132° neck angle. Connection: 5° 40' BG taper for V40™ femoral heads. Non-active, mechanical implant.

Indications for Use

Indicated for cementless primary hip surgery for 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.

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

• TMZF® Press Fit HA Stem

Submission Summary (Full Text)

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4 2002 MAR

Line Extension to the Accolade™ Hip System - Accolade™ TMZF® HA 132° Size 0 Hip Stem

K0d0572
page 1 of 2
Special 510(k) Premarket Notification

## Special 510(k) Summary

# Line Extension to the Accolade™ Hip System - Accolade™ TMZF® HA 132° Size 0 Hip Stem

Proprietary Name: Common Name: Classification Name and Reference:

Accolade™ TMZF® HA 132° Size 0 Hip Stem Artificial Hip Component Hip joint, metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis, 21 CFR §888.3353

Proposed Regulatory Class: Device Product Code:

Predicate Proprietary Name: Predicate Regulatory Class: Predicate Product Code:

For Information contact:

Class II 87 MEH

TMZF® Press Fit HA Stem Class II 87 MEH

Nancy J. Rieder Howmedica Osteonics Corp. 59 Route 17 Allendale, New Jersey 07401-1677 Phone: [phone] 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® HA 132° Size 0 Hip Stem is an addition to the existing hip stems. It features a 132° neck angle and will be offered in an additional size (size 0). The Accolade™ TMZF® HA Size 0 Hip Stem is intended for smaller size patient populations. The subject hip stem, like the predicate hip stems, is manufactured using TMZF® alloy and is also coated with a

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K0205 72
page 2 of 2

Line Extension to the Accolade™ Hip System – Accolade™ TMZF® HA 132° Size 0 Hip Stem

Snecial 510/k) Premarket Notification

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 5° 40' BG taper.

### 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® Size 0 Hip Stem component. Analysis indicates that this hip stem component successfully maintains the proper strength requirements.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 4 2002

Elizabeth A. Staub Vice President Quality Assurance, Regulatory Affairs and Clinical Research Howmedica Osteonics Corp. 59 Route 17 Allendale, New Jersey 07401-1677

Re: K020572

Trade/Device Name: Accolade TMZF HA 132° Size 0 Hip Stem Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or non-porous uncemented prosthesis Regulatory Class: Class II Product Code: MEH Dated: February 19, 2002 Received: February 21, 2002

Dear Ms. Staub:

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 for the based on 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. Elizabeth Staub

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis lotter will and w yourse FDA finding of substantial equivalence of your device to a legally promated predicated 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 11 you desire bpoints art 809.10 for in vitro diagnostic devices), please contact the Office of additionally 21 011 594-4659. 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" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Oiner general 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,

R. Adele M. Wilkerson

ia 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): K020572

Device Name: Line Extension to the Accolade™ Hip System - Accolade™ TMZF® 132° 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 5° 40' BG taper.

#### 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 ***_*** (Per 21 CFR 801.109)
(Optional Format 1-2-96)

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

510(k) Number ***_*** K020572