Optical 20-8000-020-05

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

510(k) K110054

+2 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	GUDID listing	Number00889024304796 UDI-DI	Date7 Sep 2016Listed	StatusListed GUDID: not 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	NumberK030827	Date23 May 2003Decided	StatusActive

Official records

AccessGUDID record UDI-DI 00889024304796
FDA 510(k) database 510(k) number K110054
FDA 510(k) database 510(k) number K100599
FDA 510(k) database 510(k) number K030827

Recalls

3 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-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Withdrawn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: Optical
Generic name: Orthopaedic prosthesis implantation positioning instrument, reusable
Model / Ref / Catalog: 20-8000-020-05

Primary DI / UDI-DI: 00889024304796
510(k) Number: K100599
K110054
FDA product code: OLO
GMDN term: Orthopaedic prosthesis implantation positioning instrument, reusable

Device class: Class II
Regulation number: 882.4560
GUDID distribution status: Not 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

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

Regulatory status

Recalls

Coverage

Specification

Related devices

Cleared under the same submission (K030827)

Cleared under the same submission (K100599)

Cleared under the same submission (K110054)

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 (12)