Skip to content

Hoffmann Lrf (Limb Reconstruction Frame) System

by Stryker Corp.

510(k) K113327

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

3 closed

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 NumberK113327 Date29 Mar 2012ClearedStatusActive

Recalls

3 recalls · FDA

    • Terminated Z-1526-2018 FDA Class II initiated 12 Mar 2018

    The wrong parts were picked for packaging. The connecting Nuts were packed in the packaging labeled with Hinge coupling

    • Terminated Z-0695-2013 FDA Class II initiated 25 Oct 2012

    Two complaints have been filed where Hoffman LRF Wires have broken during load bearing application by patients.

    • Terminated Z-0266-2013 FDA Class II initiated 3 Jul 2012

    Three complaints have been filed where the Hoffman LRF Telescopic Struts have broken during load bearing application by patients having a body weight greater than 250 LBS.

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  • Withdrawn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
KTT
Device Class
Class II
Regulation
21 CFR Part 888.3030
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Other devices from Stryker Corp.

See all devices from Stryker Corp. →