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K Number
K960651
Device Name
CERCLAGE WIRE CRIMP BLOCK
Manufacturer
ACU-MED, INC.
Date Cleared
1996-05-03

(78 days)

Product Code
JDQ
Regulation Number
888.3010
Type
Traditional
Panel
OR
Reference & Predicate Devices
K931246
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Acumed Wire Crimp Sleeve is a block with two holes to be used with commonly used cerclage wire. The cerclage wire is passed around the bone, passed through the crimp block, and crimped in a manner identical to the Osteo-Clage Cable System and similar to the Howmedica Dall-Miles Cable System. The only difference being the use of wire instead of cable. It is intended for use in general orthopedic repairs wherever cerclage wire is indicated.

Device Description

The Acumed Wire Crimp Sleeve is a block with two holes to be used with commonly used cerclage wire. The cerclage wire is passed around the bone, passed through the crimp block, and crimped in a manner identical to the Osteo-Clage Cable System and similar to the Howmedica Dall-Miles Cable System. The only difference being the use of wire instead of cable.

AI/ML Overview

This document is a 510(k) summary for a medical device (Acumed Wire Crimp Sleeve) and does not contain the information requested about acceptance criteria and a study proving device performance.

The provided text focuses on:

  • Device Description: What the Acumed Wire Crimp Sleeve is and how it's used.
  • Intended Use: General orthopedic repairs where cerclage wire is indicated.
  • Material: Titanium.
  • Substantial Equivalence Claim: The device is claimed to be substantially equivalent to previously cleared devices (Acumed Cerclage Wire Crimp, Osteo-Clage Cable System, Howmedica Dall-Miles Cable System). This claim is based on similarity in design, materials (with specified differences), and intended use.

Therefore, I cannot provide the requested information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert details, as this type of information is not present in the provided 510(k) summary.

§ 888.3010 Bone fixation cerclage.

(a)
Identification. A bone fixation cerclage is a device intended to be implanted that is made of alloys, such as cobalt-chromium-molybdenum, and that consists of a metallic ribbon or flat sheet or a wire. The device is wrapped around the shaft of a long bone, anchored to the bone with wire or screws, and used in the fixation of fractures.(b)
Classification. Class II.