ROSA® Robotics 20-8000-010-35

by Orthosoft Inc 2 variants

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

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

510(k) K251314

+14 more

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

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK251314	Date13 Nov 2025Decided	StatusActive
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Special	NumberK242864	Date18 Oct 2024Decided	StatusActive
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK232533	Date16 Nov 2023Decided	StatusActive
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK230243	Date29 Mar 2023Decided	StatusActive
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Special	NumberK230180	Date22 Feb 2023Decided	StatusActive
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK221928	Date4 Oct 2022Decided	StatusActive
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK213708	Date22 Apr 2022Decided	StatusActive
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK210121	Date19 Apr 2021Decided	StatusActive
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK182964	Date24 Jan 2019Decided	StatusActive
United States	GUDID listing	Number00889024304574 UDI-DI	Date7 Sep 2016Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Special	NumberK110054	Date24 Mar 2011Decided	StatusActive
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK100599	Date5 Apr 2010Decided	StatusActive
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK071929	Date19 Sep 2007Decided	StatusActive
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Special	NumberK071714	Date20 Jul 2007Decided	StatusActive
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Special	NumberK060336	Date28 Apr 2006Decided	StatusActive
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK030827	Date23 May 2003Decided	StatusActive

Official records

AccessGUDID record UDI-DI 00889024304574
FDA 510(k) database 510(k) number K251314
FDA 510(k) database 510(k) number K242864
FDA 510(k) database 510(k) number K232533
FDA 510(k) database 510(k) number K230243
FDA 510(k) database 510(k) number K230180
FDA 510(k) database 510(k) number K221928
FDA 510(k) database 510(k) number K213708
FDA 510(k) database 510(k) number K210121
FDA 510(k) database 510(k) number K182964
FDA 510(k) database 510(k) number K110054

Recalls

9 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-2048-2017 FDA Class II initiated 9 Jun 2009 on shared 510(k) K071929
Zimmer CAS voluntarily conducted a retrospective recall on specific P7 Position Sensors (Cameras), installed on Sesamoid and Sesamoid Plasty CAS workstations due to a series of these components determined to be affected with a manufacturing issue whereby they may potentially stop functioning during usage.
- 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-0985-2009 FDA Unclassified (pre-2012) initiated 19 Aug 2008 on shared 510(k) K071714
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
- 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.
- Terminated Z-2227-2017 FDA Class II initiated 4 Jun 2008 on shared 510(k) K071929
Zimmer CAS voluntarily conducted a retrospective recall of the Sesamoid Plasty due to the risk of the top of the workstation to potentially fall over during disassembly.
- Terminated Z-2445-2008 FDA Unclassified (pre-2012) initiated 6 Aug 2007 on shared 510(k) K030827
Inadequate weld on tracker, knob oversized and poor thread design on attachment screw results in seizing. The instrument may break during use, resulting in surgical delay and an increased risk of infection.

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

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: ROSA® Robotics
Generic name: Orthopaedic prosthesis implantation positioning instrument, reusable
Model / Ref / Catalog: 20-8000-010-35

Primary DI / UDI-DI: 00889024304574
510(k) Number: K100599
K110054
K182964
K210121
K213708
K221928
K230180
K230243
K232533
K242864
K251314
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

Other devices from Orthosoft Inc

Sesamoid® System 20-8000-000-01 Open recall

Class II
Sesamoid® System 20-8000-000-02 Open recall

Class II
ROSA® Robotics 20-8000-010-06 Open recall

Class II
ROSA® Robotics 20-8000-010-33 Open recall

Class II
ROSA® Robotics 20-8000-010-35 Open recall

Class II
ROSA® Robotics 20-8000-010-17 Open recall

Class II

See all devices from Orthosoft Inc →

Properties

Sterilise before use
Prescription use
Lot / batch number
Manufacturing date

Other properties (11)

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

Regulatory status

Recalls

Coverage

Specification

Related devices

Cleared under the same submission (K030827)

Cleared under the same submission (K060336)

Cleared under the same submission (K071714)

Cleared under the same submission (K071929)

Cleared under the same submission (K100599)

Cleared under the same submission (K110054)

Cleared under the same submission (K182964)

Cleared under the same submission (K210121)

Cleared under the same submission (K213708)

Cleared under the same submission (K221928)

Cleared under the same submission (K230180)

Cleared under the same submission (K230243)

Cleared under the same submission (K232533)

Cleared under the same submission (K242864)

Cleared under the same submission (K251314)

Similar devices

Other devices from Orthosoft Inc

Sesamoid® System 20-8000-000-01 Open recall

Sesamoid® System 20-8000-000-02 Open recall

ROSA® Robotics 20-8000-010-06 Open recall

ROSA® Robotics 20-8000-010-33 Open recall

ROSA® Robotics 20-8000-010-35 Open recall

ROSA® Robotics 20-8000-010-17 Open recall

Properties

Other properties (11)