← Product Code [LZO](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/LZO) · K964150

# WHITESIDE BIOMECHANICS ZIRCONIA CERAMIC FEMORAL HEAD (K964150)

_Whiteside Biomechanics, Inc. · LZO · Dec 27, 1996 · Orthopedic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/LZO/K964150

## Device Facts

- **Applicant:** Whiteside Biomechanics, Inc.
- **Product Code:** [LZO](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/LZO.md)
- **Decision Date:** Dec 27, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 888.3353
- **Device Class:** Class 2
- **Review Panel:** Orthopedic
- **Attributes:** Therapeutic

## Intended Use

This device is intended to be used for: 1. noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis, 2. rheumatoid arthritis, 3. correction of functional deformity, 4. revision procedures where other treatments or devices have failed, 5. treatment of non-unions, femoral neck and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques, 6. treatment/reduce pain, 7. treatment of osteomyelitis, 8. endoprosthesis femoral osteotomy, 9. use determined by the physician using sound medical judgment.

## Device Story

Zirconia ceramic femoral head; spherical design with 12/14 taper trunnion bore; articulates with polyethylene acetabular component. Used in hip arthroplasty procedures; implanted by orthopedic surgeons. Provides load-bearing surface for hip joint replacement; restores joint function; reduces pain in patients with degenerative or traumatic hip conditions.

## Clinical Evidence

No clinical data provided; bench testing only.

## Technological Characteristics

Magnesia stabilized zirconia ceramic; 12/14 taper trunnion bore; spherical geometry; sterilized via 100% ethylene oxide in nitrogen per AAMI guidelines.

## Regulatory 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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K964150

# 510(k) Statement

DEC 27 1996

## Device:

Classification Name: prosthesis, hip semiconstrained, metal, polymer, porous, uncemented

Classification No.: 87LZO

Common/Usual Name: zirconia ceramic femoral head

Proprietary Name: Whiteside Biomechanics Zirconia Ceramic Femoral Head

## Manufacturer Identification:

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

Establishment Registration Number: 1932213

## Device Description:

The Whiteside Biomechanics 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 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.

## Intended Use:

This device is intended to be used for:

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

## Additional Information:

This femoral head is made from magnesia stabilized zirconia ceramic. The device is to 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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**Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/LZO/K964150](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/LZO/K964150)

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