20-8000-070-21

by Orthosoft Inc

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

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

3 closed

Documents

FDA submission, from GUDID

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00889024492752 UDI-DI	Date12 Sep 2017Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Special	NumberK060336	Date28 Apr 2006Decided	StatusActive

Official records

AccessGUDID record UDI-DI 00889024492752
FDA 510(k) database 510(k) number K060336

Recalls

3 recalls · FDA

- Terminated Z-0558-2010 FDA Unclassified (pre-2012) initiated 2 Nov 2009
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
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
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.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Generic name: Robotic surgical navigation system
Model / reference: 20-8000-070-21

Primary DI / UDI-DI: 00889024492752
510(k) Number: K060336
FDA product code: HAW
GMDN term: Robotic surgical navigation system

Device class: Class II
Regulation number: 882.4560
GUDID distribution status: In Commercial Distribution

Sterilisation method: Moist Heat or Steam Sterilization

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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