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K Number
K963671
Device Name
OSTEONICS FLANGED POLYETHYLENE ACETABULAR CUP
Manufacturer
OSTEONICS CORP.
Date Cleared
1997-02-03

(143 days)

Product Code
JDI
Regulation Number
888.3350
Type
Traditional
Panel
OR
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Osteonics® Flanged Polyethylene Acetabular Cups are single-use devices which are intended for cemented fixation within the prepared acetabulum. The Osteonics® Flanged Polyethylene Acetabular Cups are compatible with any appropriately selected Osteonics hip stem/femoral head combination.

Indications:
The indications for the use of this acetabular component, in keeping with those of other legally marketed Osteonics acetabular components, are as follows:

  • Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid . arthritis, post-traumatic arthritis or late stage avascular necrosis.
  • . Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
  • . Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
  • Where bone stock is of poor quality or is inadequate for other reconstructive techniques as . indicated by deficiencies of the acetabulum.
Device Description

The key features of the Osteonics® Flanged Polyethylene Acetabular Cups are:

  • Size range: The cups are available in outer diameter (O.D.) sizes ranging from 40 64mm, . and inner diameter (I.D.) sizes of 22, 26, and 28mm.
  • Materials: The body of each cup is made from ultra-high molecular weight polyethylene . (UHMWPE). Each cup features a cobalt chromium alloy x-ray marker wire.
  • . Flanged design: The peripheral flange pressurizes the bone cement which may, in turn, improve the cement/bone interdigitation. The flange can be trimmed intraoperatively for a customized fit.
  • Cement spacers: The outer/back face of the cup features cement spacers that are formed during . production by machined cuts made upon the surface of the spacers facilitate attainment of a uniform cement mantle.
AI/ML Overview

This document doesn't contain information about the acceptance criteria or a study proving that a device meets those criteria. Instead, it is a 510(k) Premarket Notification Summary for Osteonics® Flanged Polyethylene Acetabular Cups, focusing on establishing substantial equivalence to previously cleared predicate devices.

Specifically, it details:

  • Submission Information: Sponsor, contact, date, device identification (proprietary name, common name, classification, product code).
  • Predicate Device Identification: Lists competitive and Osteonics devices deemed substantially equivalent by FDA previously.
  • Device Description: Key features like size range, materials (UHMWPE, cobalt chromium alloy x-ray marker wire), flanged design for cement pressurization, and cement spacers.
  • Intended Use and Indications: For cemented fixation in the acetabulum, compatible with Osteonics hip stem/femoral head, and indications for painful hip joint conditions.
  • Statement of Technological Comparison: Compares the subject device to predicate devices based on materials, intended use, and design, arguing for substantial equivalence.
  • Performance Data: States that comparative tests were performed to evaluate push-out strength, torsional strength, and cement pressurization, and that these tests "have proven...that the subject devices are substantially equivalent to the cited predicate devices."

However, it does not provide:

  1. A table of specific acceptance criteria.
  2. Reported device performance against those criteria.
  3. Details about the study design (sample sizes, data provenance, ground truth establishment, expert qualifications, etc.).
  4. Information about MRMC studies, standalone algorithm performance, or training set details.

The summary only broadly claims that the conducted tests proved substantial equivalence based on mechanical characteristics, without presenting the data or the specific metrics used for comparison.

§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. A hip joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.