302.4002

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

2 closed

Documents

FDA submission, from GUDID

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00889024211605 UDI-DI	Date14 Sep 2016Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Special	NumberK071714	Date20 Jul 2007Decided	StatusActive

Recalls

2 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-0985-2009 FDA Unclassified (pre-2012) initiated 19 Aug 2008
Incorrect parameters: If the user switches from one surgeon profile to another surgeon profile after completing anatomical landmark acquisition tasks, the application will continue to use the initial surgeon profile parameter values in the calculation of the predicted hip-knee-ankle alignment estimates, which may have different resection or component thickness parameters than are appropriate for

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Generic name: Robotic surgical navigation system
Model / Ref / Catalog: 302.4002

Primary DI / UDI-DI: 00889024211605
510(k) Number: K071714
FDA product code: HAW
GMDN term: Robotic surgical navigation system

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

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See all devices from Orthosoft Inc →

Properties

Single use
Prescription use
Lot / batch number

Other properties (12)

Supplied sterile: No
Sterilise before 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