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Smarttools Knee System

by Zimmer

510(k) K122326

Smarttools Knee System is a Class II device made by Zimmer, cleared under FDA 510(k) K122326 on 30 Nov 2012, active as of 22 Oct 2026. 2 FDA recalls are linked to it.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK122326 Date30 Nov 2012ClearedStatusActive

Official records

Recalls

2 recalls · FDA

    • Terminated Z-1868-2017 FDA Class II initiated 20 Feb 2017

    There has been an increase in the number of complaints regarding bent or broken Drive Pins of the Validation Tool manufactured with drawing Revision M to P

    • Terminated Z-1701-2015 FDA Class II initiated 19 Apr 2015

    Zimmer CAS has determined that the potential exists for the spikes on the iASSIST Tibial Alignment Guide to bend or break during insertion or extraction from the tibia during use.

Timeline

3 dated events

  1. Cleared FDA 510(k) K122326
  2. Recall initiated FDA recalls Z-1701-2015
  3. Recall initiated FDA recalls Z-1868-2017

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  • Withdrawn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
OLO
Device class
Class II
Regulation
21 CFR Part 882.4560
Advisory committee
Neurology
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

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