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K Number
K031217
Device Name
GMRS PRESS FIT STEMS WITH PUREFIX HA
Manufacturer
HOWMEDICA OSTEONICS
Date Cleared
2003-05-23

(36 days)

Product Code
LZO
Regulation Number
888.3353
Type
Traditional
Panel
OR
Reference & Predicate Devices
K022403
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Global Modular Replacement System (referred to from this point on as the GMRS) Press Fit Stems with PureFix® HA Coating were found substantially equivalent in premarket notification K022403. These stems are intended to be used with components of the proximal femoral segment of the Howmedica Modular Replacement System (referred to from this point on as the MRS) in total hip arthroplasty. These devices are intended for use in total hip arthroplasty indicated as a result of extensive proximal femoral bone loss (from trauma, failed previous arthroplasty, or tumor resection). Adequate bone stock must be present to allow the use of the GMRS Pre PureFix® HA Coating.

Indications:
Proximal femoral reconstruction secondary to:

  • . Trauma
  • Failed previous prosthesis .
  • Tumor resection .

The 11mm diameter GMRS Press Fit Stems with PureFix® HA will bear a weight limitation on the label. The 11mm stems will be limited to use in patients with a maximum weight of 199 lbs.

Device Description

GMRS Press Fit Stems with PureFix® HA

AI/ML Overview

I am sorry, but based on the provided document, there is no information about acceptance criteria or a study proving that a device meets those criteria. The document is a 510(k) premarket notification for a labeling change to an existing medical device (11mm GMRS Press Fit Stem with PureFix® HA).

The document primarily focuses on:

  • Identification of the device: GMRS Press Fit Stems with PureFix® HA.
  • Intended use and indications: For total hip arthroplasty due to extensive proximal femoral bone loss.
  • The purpose of the current submission: To add a warning with a weight limitation (199 lbs) to the package label for the 11mm GMRS Press Fit Stems.
  • FDA's response: A substantial equivalence determination for the labeling change.

There are no details about:

  • Specific performance metrics or acceptance criteria for the device itself.
  • Any studies (clinical or non-clinical) conducted to demonstrate performance against such criteria.
  • Sample sizes, data provenance, expert qualifications, or ground truth establishment.
  • Multi-reader multi-case studies or standalone algorithm performance.

Therefore, I cannot fulfill your request for the table and study details as that information is not present in the provided text.

§ 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.