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K2 Bone Screw System

by Kinetikos Medical, Inc.

510(k) K960537

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)SN Traditional NumberK960537 Date25 Mar 1996DecidedStatusActive

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  • Withdrawn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
HWC
Device Class
Class II
Regulation
21 CFR Part 888.3040
Advisory Committee
Orthopedic
FDA Decision
SN

Overview

AI-generated summary, 26 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 K2 Bone Screw System is an orthopedic device used for fixation and stabilization of small bone hand or small bone forefoot fractures. It is a Class 2 device with product code HWC. The system consists of bone screws with the same thread configuration and length as those offered by other orthopedic companies.

The K2 Bone Screw System is supplied with specifications meeting ASTM standards for material and design. It has been cleared through the Traditional 510(k) pathway and has FDA 510(k) clearance, with the decision description being Substantially Equivalent for Some Indications. The device is manufactured by Kinetikos Medical, Inc. and has a product code of HWC and k number K960537.

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Questions

AI-generated answers, 26 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 K2 Bone Screw System used for?

    The K2 Bone Screw System is used for fixation and stabilization of small bone hand or small bone forefoot fractures, providing a solution for orthopedic conditions.

  • Is the K2 Bone Screw System supplied sterile?

    The description does not explicitly state that the K2 Bone Screw System is supplied sterile, but it does meet ASTM standards for material and design, ensuring a certain level of quality and safety.

  • What is the regulatory status of the K2 Bone Screw System?

    The K2 Bone Screw System has been cleared through the Traditional 510(k) pathway and has FDA 510(k) clearance, with the decision description being Substantially Equivalent for Some Indications.

  • What are the specifications of the K2 Bone Screw System?

    The K2 Bone Screw System consists of bone screws with the same thread configuration and length as those offered by other orthopedic companies, meeting ASTM standards for material and design.