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FastLok Staple and Buckle Fixation System

by Neoligaments, Ltd. 2 variants

510(k) K911445

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK911445 Date28 Jun 1991ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
JDR
Device Class
Class II
Regulation
21 CFR Part 888.3030
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The FastLok Staple and Buckle Fixation System is an orthopedic device designed for cortical bone fixation. It combines a staple and a buckle mechanism to secure sutures or tapes, providing a stable fixation point during surgical procedures. The system is intended for applications requiring high fixation strength in bone, ensuring reliable attachment of soft tissues or grafts. Its design allows for secure weave-through of USP #2 sutures or larger, facilitating versatile surgical techniques.

This system is supplied as a sterile, single-use device and is classified under FDA product code JDR for orthopedic applications. It is intended for use in operating room settings and requires proper handling to maintain sterility. The device has received FDA 510(k) clearance under traditional review, with the classification of substantially equivalent to predicate devices. No MRI safety information is specified, and storage conditions should follow standard orthopedic fixation device protocols.

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