(78 days)
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.
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.
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.
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Ouality Orthopaedic Instruments and Implants
Enclosure D - 510(k) Summary
MAY - 3 1996
This summary regarding 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.93.
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.
The sleeve is manufactured from titanium per ASTM F 136. It is intended for use with titanium or cobalt chromium cerclage wire.
Information regarding implantation, packaging, and labeling have been provided.
This medical device is identical except for material type to the Acumed Cerclage Wire Crimp (K931246). Both the Acumed Cerclage Wire Crimp and the Richards Orthopedic Cable System are manufactured from titanium. In addition, the Acumed Cerclage Wire Crimp may be found substantially equivalent to the Osteo-Clage Cable System and the Howmedica Dall-Miles Cable System, is safe and effective, and is expected to perform as well as similar devices.
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Randall Hu ident, Acume
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- 10950 SW 5th St., Suite 170 ◆ Beaverton, OR 97005 ◆ (503) 627-9957 ◆ Fax: (503) 643-1909 ◆ Form # FOCL-22 02/09/96 Page 8 of 9 © 1995, Acumed, Inc.
§ 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.