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K Number
K992144
Device Name
BIOPRO RIMMED ACETABULAR COMPOMENT
Manufacturer
BIOLOGICALLY ORIENTED PROSTHESES
Date Cleared
1999-09-22

(90 days)

Product Code
LZO
Regulation Number
888.3353
Type
Traditional
Panel
OR
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
  1. Osteoarthritis
  2. Rheumatoid arthritis with severe hip pain and limited joint motion.
  3. Avascular necrosis
  4. Traumatic arthritis
  5. Acetabular cavity deformities caused by congenital problems.
  6. Revisional surgery after one or more total hip operations.
  7. Fixation with bone cement and/or cancellous bone screws.
Device Description

The rimmed acetabular component is manufactured of Titanium 6 A1-4V Bli (ASTM F136). It is available in five sizes: 54mm, 58mm, 64mm, 70mm, and 76mm. The BioPro rimmed acetabular component accommodates BioPro's 28nun and 32mm Cox Comb inserts: 28x55 (10068), 28x58 (10069), 28x65 (10071), 28x69 (10074), 28x75 (11227), 32x55 (10077), 32x58 (10078), 32x65 (10081), 32x69 (10083), and 32x75 (10084).

AI/ML Overview

This document is a 510(k) summary for the BioPro Rimmed Acetabular Component, detailing its substantial equivalence to a predicate device. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The document focuses on regulatory approval based on equivalence rather than performance testing against specific criteria.

Therefore, I cannot provide the requested information about acceptance criteria, device performance, study details, sample sizes, ground truth establishment, or multi-reader multi-case studies from the provided text. This type of information is typically found in design validation reports or clinical study summaries, which are not part of this 510(k) 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.