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Optical 20-8000-020-14

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

None ongoing

5 closed

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 Number00889024304888 UDI-DI Date12 Sep 2016ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK100599 Date5 Apr 2010DecidedStatusActive

Official records

Recalls

5 recalls · FDA

    • Terminated Z-0558-2010 FDA Unclassified (pre-2012) initiated 2 Nov 2009 on shared 510(k) K071929

    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-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.

    • Terminated Z-2444-2008 FDA Unclassified (pre-2012) initiated 27 Apr 2006 on shared 510(k) K041369

    The three-point array 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

United States of America
  • 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  • Withdrawn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
20-8000-020-14
Primary DI / UDI-DI
00889024304888
510(k) Number
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

Related devices

Cleared under the same submission (K030827)

Show all (11)

Cleared under the same submission (K041369)

Cleared under the same submission (K071929)

Show all (9)

Cleared under the same submission (K100599)

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