CITATION TMZF HA STEM

K993768 · Howmedica Osteonics Corp. · MEH · Jan 21, 2000 · Orthopedic

Device Facts

• Record ID: K993768
• Device Name: CITATION TMZF HA STEM
• Applicant: Howmedica Osteonics Corp.
• Product Code: MEH · Orthopedic
• Decision Date: Jan 21, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3353
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Citation TMZF HA Stem is indicated for cementless primary hip surgery in cases of non-inflammatory degenerative joint disease including osteoarthritis, avascular necrosis, rheumatoid arthritis, and correction of functional deformity. Additionally it can be used in treatment of nonunion, and femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques. It is also indicated for use in revision procedures where other treatments or devices have failed.

Device Story

Anatomic femoral stem for hip arthroplasty; used in primary reconstruction or revision. Fabricated from TMZF alloy; features CP titanium plasma spray coating and Pure-Fix™ HA coating. Larger diameter stems include rotated distal slot with distal flutes/grooves. Compatible with Howmedica Osteonics acetabular components and V40 femoral heads (5° 40' BG taper). Implanted by orthopedic surgeons in clinical/OR settings to replace femoral head/neck. Provides structural support for hip joint; facilitates bone fixation via HA coating. Benefits patients by restoring joint function and mobility.

Clinical Evidence

Bench testing only. Testing confirmed that the addition of HA coating over the plasma spray coating has no effect on the stem fatigue strength.

Technological Characteristics

Materials: TMZF alloy, CP titanium plasma spray, Pure-Fix™ HA coating. Design: Anatomic femoral stem, various lengths/diameters, rotated distal slot with flutes/grooves on larger sizes. Interface: 5° 40' BG taper for V40 femoral heads. Energy source: N/A (mechanical implant).

Indications for Use

Indicated for patients requiring cementless primary hip surgery or revision due to non-inflammatory degenerative joint disease (osteoarthritis, avascular necrosis, rheumatoid arthritis), functional deformity, nonunion, or proximal femoral fractures (femoral neck/trochanteric) unmanageable by other techniques.

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

• Meridian® Titanium Femoral Stem (K972228)
• Howmedica® Asymmetric Stem Femoral Component (K955871)
• Osteonics® Omnifit® AD-HA Hip Stem Series (K941366)

Submission Summary (Full Text)

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JAN 2 1 2000

## 510(k) Summary

Device: Citation TMZF HA Stem

The Citation TMZF HA Stems are anatomic stems in a variety of lengths and distal diameters. The larger diameter stems have a rotated distal slot that contains distal flutes or grooves.

This stem is intended for the reconstruction of the head and neck of the femoral joint. The device is intended for primary reconstruction of the proximal femur or revision of a previous total hip arthroplasty. The stems can be used with any currently available Howmedica Osteonics acetabular components and V40 Femoral Heads that can be mated with a 5° 40' BG taper.

The Citation TMZF HA Stems will be fabricated from TMZF Alloy. The stems are coated with a CP Titanium plasma spray coating and Pure-Fix™ HA.

The substantial equivalence of the Citation TMZF HA Stems is based upon equivalence in intended use, materials, design, and operational principles to Meridian® Titanium Femoral Stem (K972228); the Howmedica® Asymmetric Stem Femoral Component (K955871); and the Osteonics® Omnifit® AD-HA Hip Stem Series (K941366).

Testing indicates that the addition of the HA coating over plasma spray has no effect on the stem fatigue strength.

| For information contact: | Jennifer A. Daudelin |
|--------------------------|-------------------------------|
| | Rutherford Regulatory Affairs |
| | Howmedica Osteonics Corp. |
| | 359 Veterans Boulevard |
| | Rutherford, NJ 07070 |
| Phone: | [phone] |
| Fax: | [phone] |

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The eagle is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 21 2000

Ms. Jennifer A. Daudelin Regulatory Affairs Stryker Howmedica Osteonics 359 Veterans Boulevard Rutherford, New Jersey 07070

Re: K993768 Trade Name: Citation TMZF HA Stem Regulatory Class: II Product Code: MEH Dated: October 29, 1999 Received: November 8, 1999

Dear Ms. Daudelin:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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.

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Page 2 - Ms. Jennifer A. Daudelin

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Russell Sage

James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K993768

Device Name: Citation TMZF HA Stem

Indications for Use:

The Citation TMZF HA Stem is indicated for cementless primary hip surgery in cases of non-inflammatory degenerative joint disease including osteoarthritis, avascular necrosis, rheumatoid arthritis, and correction of functional deformity. Additionally it can be used in treatment of nonunion, and femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques. It is also indicated for use in revision procedures where other treatments or devices have failed.

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| | Concurrence of CDRH, Office of Device Evaluation (ODE) |
|---------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------|
| Prescription Use<br>OR<br>(Per 21 CFR 801.109)<br>(Division Sian-Off)<br>Division of General Resto<br>510(k) Number | Over-The-Counter Use<br>(Optional Format 1-2-96) |