Skip to content

Optical 20-8000-010-10

by Orthosoft Inc

Active United States. Also listed in GUDID (US), not in commercial distribution.

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 2 Nov 2026. What this means

Regulatory status

as of registry sync 2 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00889024304338 UDI-DI Date7 Sep 2016ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK110054 Date24 Mar 2011DecidedStatusActive

Official records

Recalls

5 recalls · 1 ongoing · FDA

    • Ongoing Z-0721-2022 FDA Class II initiated 7 Jan 2022

    The product was released for distribution without passing sterilization results, which could potentially lead to insufficient sterility of the product. The highest severity risk is infection leading to surgical intervention.

    • Terminated Z-1881-2017 FDA Class II initiated 6 Oct 2011

    Zimmer CAS voluntarily conducted a retrospective recall of the Navitrack System - OS Knee Universal software ORTHOsoft-UniTkr-2.3.2.6, due to a calibration sequence crash.

    • Terminated Z-0558-2010 FDA Unclassified (pre-2012) initiated 2 Nov 2009 on shared 510(k) K060336

    The power cord female receptacle is not recessed sufficiently and may present a shock hazard.

    • Terminated Z-2076-2017 FDA Class II initiated 28 Oct 2008 on shared 510(k) K060336

    Zimmer CAS voluntarily conducted a retrospective recall of the Navitrack System OS Knee Universal software versions 2.2.0.82, 2.2.1.3, 2.1.6.0.2, D.54 and A.42 due to software issues resulting in erros and discrepancies .

    • Terminated Z-2075-2017 FDA Class III initiated 20 Jun 2008 on shared 510(k) K060336

    ZIMMER CAS voluntarily conducted a retrospective recall of the Navitrack System - OS Knee Universal, due to software anomalies which were corrected with a new revision in version 2.2.1.3.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Optical
Generic name
Osteotomy guide, reusable
Model / Ref / Catalog
20-8000-010-10
Primary DI / UDI-DI
00889024304338
510(k) Number
FDA product code
OLO
GMDN term
Osteotomy guide, reusable
Device class
Class II
Regulation number
882.4560
GUDID distribution status
Not in Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Cleared under the same submission (K060336)

Show all (12)

Cleared under the same submission (K100599)

Show all (12)

Cleared under the same submission (K110054)

Show all (12)

Other devices from Orthosoft Inc

See all devices from Orthosoft Inc →

Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number

Other properties (12)

  • Supplied sterile: No
  • Single use: No
  • Implantable: No
  • Contains latex: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Serial number: No
  • Expiration date: No
  • Manufacturing date: No