(87 days)
This device is intended to be used for :
- noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis,
- rheumatoid arthritis,
- correction of functional deformity,
- revision procedures where other treatments or devices have failed, and
- treatment of non-unions, femoral neck and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
The Whiteside Biomechanics, Inc. Ceramic Unipolar Femoral Head is composed of magnesia partially stabilized zirconia (MG-PSZ). The head is generally spherical with a Whiteside Biomechanics, Inc. 12/14 bore machined from distal to proximal. Around the base of the bore a flat will be machined and will be laser-engraved for labeling purposes.
The provided text is a 510(k) summary for the Whiteside Biomechanics, Inc. Ceramic Unipolar Femoral Head, and it does not contain information about acceptance criteria or a study demonstrating the device meets such criteria.
The document primarily covers:
- Device Identification: Classification name, number, common name, proprietary name, and manufacturer details.
- Device Description: Material composition (magnesia partially stabilized zirconia), spherical shape, and bore specifications.
- Intended Use: Five specific indications for use in hip replacement procedures.
- Additional Information: Material composition reiteration, sterilization method (ETO with nitrogen), and labeling for sterilization indicators.
- FDA Communication: A letter from the FDA confirming substantial equivalence to pre-amendment devices, outlining regulatory class (II) and product code (LZO), and specifying a limitation regarding use with titanium alloy hip stems with Whiteside Biomechanics, Inc. 12/14 taper trunnions.
- Indications for Use Form: A summary of the intended uses.
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets them because this data is not present in the provided document.
This type of 510(k) summary focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance studies with acceptance criteria, sample sizes, ground truth establishment, or specific expert involvement for a standalone or MRMC study. Typically, such studies would be included in the full 510(k) submission, not necessarily in the publicly available summary.
§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
(a)
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.(b)
Classification. Class II.