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20-8011-050-00

by Orthosoft Inc

20-8011-050-00 is a Class II device made by Orthosoft Inc, cleared under FDA 510(k) K122326 on 30 Nov 2012 and listed in FDA GUDID since 7 Sep 2016 (UDI-DI 00889024305434), active as of 23 Oct 2026. 2 FDA recalls are linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

Documents

510(k) K122326

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00889024305434 UDI-DI Date7 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK122326 Date30 Nov 2012DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K122326 decided 30 Nov 2012 Active
  • FDA GUDID UDI-DI 00889024305434 listed 7 Sep 2016 Listed

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

4 dated events

  1. Cleared FDA 510(k) K122326
  2. Recall initiated FDA recalls Z-1701-2015
  3. Listed FDA GUDID 00889024305434
  4. 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  • Withdrawn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

GUDID

Generic name
Orthopaedic prosthesis implantation positioning instrument, reusable
Model / Ref / Catalog
20-8011-050-00
Primary DI / UDI-DI
00889024305434
510(k) Number
FDA product code
OLO
GMDN term
Orthopaedic prosthesis implantation positioning instrument, reusable
Device class
Class II
Regulation number
882.4560
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Orthopaedic prosthesis implantation positioning instrument, reusable

Cleared under the same submission (K122326)

and 8 more cleared under K122326

Similar devices in this category

Other devices filed under Orthopaedic prosthesis implantation positioning instrument, reusable.

Other devices from Orthosoft Inc

See all devices from Orthosoft Inc →

Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number
Other properties (12, all answered No)