Who is the manufacturer of WHITESIDE BIOMECHANICS ZIRCONIA CERAMIC FEMORAL HEAD?

Whiteside Biomechanics, Inc. submitted the Traditional clearance for WHITESIDE BIOMECHANICS ZIRCONIA CERAMIC FEMORAL HEAD (K964150).

What is the FDA product code for WHITESIDE BIOMECHANICS ZIRCONIA CERAMIC FEMORAL HEAD?

LZO. It is classified under 21 CFR 888.3353 as a Class 2 device in the Orthopedic panel.

What is the regulatory pathway for WHITESIDE BIOMECHANICS ZIRCONIA CERAMIC FEMORAL HEAD?

510(k) clearance (submission type: Traditional).

WHITESIDE BIOMECHANICS ZIRCONIA CERAMIC FEMORAL HEAD

K964150 · Whiteside Biomechanics, Inc. · LZO · Dec 27, 1996 · Orthopedic

Device Facts

Record ID	K964150
Device Name	WHITESIDE BIOMECHANICS ZIRCONIA CERAMIC FEMORAL HEAD
Applicant	Whiteside Biomechanics, Inc.
Product Code	LZO · Orthopedic
Decision Date	Dec 27, 1996
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: 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.

Indications for Use

Indicated for patients requiring hip arthroplasty due to noninflammatory degenerative joint disease (osteoarthritis, avascular necrosis), rheumatoid arthritis, functional deformity, revision surgery, non-unions, or proximal femoral fractures with head involvement.

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.

Related Devices

K971721 — WHITESIDE BIOMECHANICS, INC. ZIRCONIA CERAMIC FEMORAL HEAD · Whiteside Biomechanics, Inc. · Jul 30, 1997
K013989 — ZIRCONIA CERAMIC FEMORAL HEAD - 12/14 TAPER · Smith & Nephew, Inc. · Dec 19, 2001
K955117 — IMPLEX CERAMIC HEAD · Implex Corp. · Apr 5, 1996
K971414 — ZIRCONIA PROZYR CERAMIC 12/14 GLOBAL TAPER (GT) FEMORAL HEADS · Smith & Nephew, Inc., Orthopaedic Div. · Jul 16, 1997
K965002 — ZIRCONIA CERAMIC FEMORAL HEADS WITH FOUNDATION FORGED, TEXTURED AND POROUS STEMS, THE ENCORE VITALITY STEMS AND SL AND · Encore Orthopedics, Inc. · Jun 27, 1997

Submission Summary (Full Text)

{0} 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.