Skip to content

Arthrex TensionLok

by Arthrex, Inc.

510(k) K052901

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 · Special NumberK052901 Date12 Dec 2005ClearedStatusActive

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  • Withdrawn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
HRS
Device class
Class II
Regulation
21 CFR Part 888.3030
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 28 Sep 2026

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

The Arthrex TensionLok is a bone fixation plate classified within the HRS product code category, which comprises bone fixation plates and orthopedic hardware. It is intended for fixation of bone to bone or soft tissue to bone, serving as a fixation post, a distribution bridge, or for distributing suture tension.

The device received FDA 510(k) clearance (K052901) on December 12, 2005, as a substantially equivalent device with special controls. It is manufactured by Arthrex, Inc. in Naples, Florida, and is classified as a Class II device under the Orthopedic advisory committee review.

Other devices from Arthrex, Inc.

See all devices from Arthrex, Inc. →

Questions

AI-generated answers, 28 Sep 2026

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

  • What is the Arthrex TensionLok used for?

    The Arthrex TensionLok is intended for fixation of bone to bone or soft tissue to bone, functioning as a fixation post, a distribution bridge, or to distribute suture tension in orthopedic procedures.

  • How is the Arthrex TensionLok supplied and is it reusable?

    The device data does not specify whether the Arthrex TensionLok is supplied sterile or non-sterile, or whether it is designed for single-use or reuse; this information must be obtained from the product labeling or manufacturer’s instructions for use.

  • What regulatory pathway was used for the Arthrex TensionLok?

    The Arthrex TensionLok received FDA 510(k) clearance (K052901) on December 12, 2005, as a substantially equivalent device with special controls, and is classified as a Class II device under the Orthopedic advisory committee review.