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K Number
K973453
Device Name
TORNIER CEMENT RESTRICTOR
Manufacturer
TORNIER
Date Cleared
1997-12-09

(89 days)

Product Code
JDI,87L
Regulation Number
888.3350
Type
Traditional
Panel
SU
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
    1. Total Shoulder Arthroplasty
    1. Total Hip Arthroplasty
    1. Intramedullary Occlusion
    1. Cement Pressurization
Device Description

Not Found

AI/ML Overview

The provided text is a summary of safety and effectiveness information for the Tornier Cement Restrictor, submitted as a premarket notification (510(k)) to the FDA. It does not contain information about acceptance criteria for a device's performance, nor does it describe any study proving the device meets particular acceptance criteria.

The document primarily focuses on:

  • Device Identification: Name (Tornier Cement Restrictor), common name (Canal Plug, Cement Restrictor), classification name (Cement Obturator).
  • Regulatory Classification: Class II device under 21 CFR §878.3300 (Surgical mesh), product code 87LZN.
  • Intended Use/Indications For Use: Total Shoulder Arthroplasty, Total Hip Arthroplasty, Intramedullary Occlusion, Cement Pressurization.
  • Regulatory Correspondence: An FDA letter confirming substantial equivalence to devices marketed prior to May 28, 1976.
  • General Controls: Mentions requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

Therefore, I cannot provide the requested information from the given text as it does not contain details regarding:

  1. A table of acceptance criteria and reported device performance.
  2. Sample sizes, data provenance, or study design for test sets.
  3. Number or qualifications of experts for ground truth establishment.
  4. Adjudication method.
  5. MRMC comparative effectiveness study, including effect size.
  6. Standalone algorithm performance.
  7. Type of ground truth used (pathology, outcomes data, etc.).
  8. Sample size for the training set.
  9. How ground truth for the training set was established.

§ 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.