WHITESIDE BIOMECHANICS, INC. ZIRCONIA CERAMIC FEMORAL HEAD

K971721 · Whiteside Biomechanics, Inc. · LZO · Jul 30, 1997 · Orthopedic

Device Facts

• Record ID: K971721
• Device Name: WHITESIDE BIOMECHANICS, INC. ZIRCONIA CERAMIC FEMORAL HEAD
• Applicant: Whiteside Biomechanics, Inc.
• Product Code: LZO · Orthopedic
• Decision Date: Jul 30, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3353
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

This device is intended to be used for: - noninflammatory degenerative joint disease including osteoarthritis and 1. avascular necrosis - 2. rheumatoid arthritis - correction of functional deformity 3. - revision procedures where other treatments or devices have failed 4. - 5. treatment of non-unions, femoral neck and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques - 6. treatment of osteomyelitis - 7. endoprosthesis femoral osteotomy

Device Story

Zirconia ceramic femoral head; spherical shape with 12/14 taper trunnion bore. Designed for articulation with polyethylene acetabular components in total hip arthroplasty. Used in clinical settings by orthopedic surgeons. Implanted via surgical procedure to replace femoral head; restores joint function; reduces pain. Must be used exclusively with Whiteside Biomechanics 12/14 taper wrought titanium alloy trunnions.

Clinical Evidence

Bench testing only.

Technological Characteristics

Magnesia-stabilized zirconia ceramic. 12/14 taper trunnion bore. Dimensions: 22mm 0, 22mm +3.5, 26mm -3.5. Sterilization: 100% ethylene oxide in nitrogen per AAMI guidelines.

Indications for Use

Indicated for patients requiring hip arthroplasty due to noninflammatory degenerative joint disease (osteoarthritis, avascular necrosis), rheumatoid arthritis, functional deformity, revision of failed treatments, non-unions, femoral neck/trochanteric fractures, osteomyelitis, or endoprosthesis femoral osteotomy. Must be used with a polyethylene cup (with or without metal-backed shell).

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.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Michael C. Wall, RN Official Correspondent Whiteside Biomechanics 12634 Olive Boulevard St. Louis, Missouri 63141

# JUL 30 1997

K971721 Re :

Whiteside Biomechanics Zirconia Ceramic Femoral Head (Sizes 22mm 0, 22mm +3.5, 26mm -3.5) Regulatory Class: II Product Code: LZO Dated: May 8, 1997 Received: May 9, 1997

Dear Mr. Wall:

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 and the following limitation that the package insert must reflect that the Whiteside Biomechanics Zirconia Ceramic Femoral Head is to only be used with the Whiteside Biomechanics 12/14 taper made from wrought titanium alloy. This information must be identified in the package insert.

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.

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## Page 2 - Michael C. Wall, RN

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 Requlations, 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 immediately. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and 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 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 requlation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be

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Page 3 - Michael C. Wall, RN

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,

A Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# 510(k) Summary

K97172/

## Device:

Classification Name:

prosthesis, hip semiconstrained,metal, polymer, porous, uncemented

| Classification No.: | 87LZO |
|---------------------|--------------------------------------------------------------|
| Common/Usual Name: | zirconia ceramic femoral head |
| Proprietary Name: | Whiteside Biomechanics,Inc. Zirconia<br>Ceramic Femoral Head |

#### Manufacturer Identification:

Whiteside Biomechanics, Inc. 12634 Olive Blvd. Creve Coeur, MO 63141

1932213 Establishment Registration Number:

#### Device Description:

The Whiteside Biomechanics, Inc. Zirconia Ceramic Femoral Head will consist of a generally spherical, partially hollow (trunnion bore) ceramic ball. The implant will have a machined flat on the most distal surface with the trunnion centered and machined proximally into its center. The bore will be a Whiteside Biomechanics 12/14 taper intended to be seated on a trunnion compatible with this taper (see warning label). The head's outer perimeter is intended to articulate with a polyethylene acetabular component of compatible size. Labeling on the femoral head will be printed on a beveled surface machined around the periphery of the trunnion bore or on the top-inside flat of the bore.

#### Intended Use:

This device is intended to be used for:

- noninflammatory degenerative joint disease including osteoarthritis and 1. avascular necrosis
- 2. rheumatoid arthritis
- correction of functional deformity 3.
- revision procedures where other treatments or devices have failed 4.
- 5. treatment of non-unions, femoral neck and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques
- 6. treatment of osteomyelitis
- 7. endoprosthesis femoral osteotomy

### Additional Information:

This femoral head is made from magnesia stabilized zirconia ceramic. The device will be sterilized with 100% ethylene oxide in nitrogen according to the AAMI guidelines for sterilization. Resterilization of femoral heads upon contamination is not recommended. DO NOT RESTERILIZE.

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STOMECHAN ICAL

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# 510(k) Number (if known):

## K971721

Whiteside Biomechanics Inc. Zirconia Ceramic Femoral Head Device Name:__

Indications For Usc:

- 1 . noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis, -------
- 2. rheumatoid arthritis,
- 3. correction of functional deformity,
- 3. correction of functional detormats or devices have failed,
4. revision procedures where other treatments or devices of
- 4 . revision procedures when acaded and tochanterials of the proximal
5 . treatment of non-unions, femoral neck and tochanterial proximal treatment of non-unfolis, temoral nook and cousiness of ther techniques,
femur with head involvement, unmanageable using other techniques,
- 6. treatment of osteomyclitis,
- 7 . endoprosthesis femoral osteotomy.
- 7 . endoprosthesis remoral osteolomy :
8 . use with a polyethylene cup with or without metal backed shell.

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Concurrence of CDRH, Office of Device Evaluation

(Division Sign-Offm
Division of General Restorative Devices K971721
510(k) Number

Prescription Use (Pcr 21 CFR 801.109) ાર

Over-Thic-Counter Use_

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