(77 days)
The Acufex® Tibial Anchor Screw & Spiked Washer is indicated for fixation of soft tissue, such as tendon and ligaments, to bone in orthopedic procedures.
Acufex® Tibial Anchor Screw & Spiked Washer is a device used in soft tissue to bone fixation. The Tibial Anchor Screw is a two part screw. The outer larger part has cancellous threads, which come in direct contact with bone, and is 9 mm in diameter with a length of 20 - 30 mm. The inner part, 7 mm diameter and 20 - 25 mm length, is used to attach the Spiked Washer directly to the outer part. The spiked washer is 14 - 20 mm in diameter with spikes set at the periphery.
I am sorry. This document does not contain information about the acceptance criteria and the study that proves the device meets the acceptance criteria. It only contains a 510(k) summary for a medical device called Acufex® Tibial Anchor Screw & Spiked Washer, which describes its features and compares it to similar devices already on the market.
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JUL 16 1995
Image /page/0/Picture/1 description: The image shows a handwritten sequence of characters, which appears to be 'K 961649'. The characters are written in a bold, somewhat irregular style, giving them a distinct and unique appearance. The 'K' is capitalized and slightly separated from the numerical sequence. The numbers are closely spaced and have a consistent size.
510(K) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
The assigned 510(k) number is :
This summary was prepared on April 26, 1996
A.. Submitter
Smith & Nephew Endoscopy 130 Forbes Boulevard Mansfield, MA 02048
B. Company Contact
Tedd Gosian Clinical Regulatory Manager
C. Device Name
| Trade Name: | Acufex® Tibial Anchor Screw & Spiked Washer |
|---|---|
| Common Name: | Fixation Screw & Washer |
| Classification Name: | Single/Multiple component metallic bone fixation appliancesand accessories |
D. Predicate/Legally Marketed Devices
Concept® Soft Tissue Anchoring Implants (K871037) Synthes® Spiked Washer
E. Device Description
Acufex® Tibial Anchor Screw & Spiked Washer is a device used in soft tissue to bone fixation. The Tibial Anchor Screw is a two part screw. The outer larger part has cancellous threads, which come in direct contact with bone, and is 9 mm in diameter with a length of 20 - 30 mm. The inner part, 7 mm diameter and 20 - 25 mm length, is used to attach the Spiked Washer directly to the outer part. The spiked washer is 14 - 20 mm in diameter with spikes set at the periphery.
F. Intended Use
The Acufex® Tibial Anchor Screw & Spiked Washer is indicated for fixation of soft tissue, such as tendon and ligaments, to bone in orthopedic procedures.
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G. Substantial Equivalence
The Acufex® Tibial Anchor Screw & Spiked Washer is intended for use for fixation of soft tissue, Such as tendon and ligaments, to bone in orthopedic procedures. The Acufex® Tibial Anchor Screw & Spiked Washer is similaris in besign, function, materials and intended use to other devices currently marketed and in commercial distribution, nately Concept® Soft Times de Soft Times de Soft Tissue Anchoring Implants (K871037) and Synthes® Spiked Washer.
Risks to health have been addressed through the specified materials, processing controls, quality assurance, and compliance through the Specified materials, processing controls, questions, que
A summary comparison of the characteristics of the Acufex® Tibial Anchor Screw & Spiked Washer and the substantially equivalent device is presented in the table below.
| Current Product | Substantially EquivalentProduct | ||
|---|---|---|---|
| Attribute↓ | Acufex®Tibial Anchor Screw &Spiked Washer | Concept® Soft TissueAnchoring Implants | Synthes®Spiked Washer |
| Indication | Soft Tissue Fixation | Soft Tissue Fixation | Ligament Fixation |
| Length | Outer: 20 - 30 mmInner: 18 - 25 | Screw: 25 - 55 mm | |
| Diameter | Outer: 9 mm.Inner: 7 mmWasher: 14 - 20 mm O.D. | Screw: 6.5 mm -.Washer: 14 to 20 mm O.D. | Washer: 13.5 mm O.D. |
| Materials | Screw: TitaniumWasher: TitaniumReinforced PolyacetalPolymer | Screw: TitaniumWasher: Titanium | Washer: Stainless Steelreinforced polyacetal |
| Labeling | Sterile, Single Use Only | Sterile, Single Use Only | Sterile, Single Use Only |
Applicant
Date 4/26/96
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.