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LOSPA Knee System 01.62.007

by Corentec Co., Ltd

LOSPA Knee System 01.62.007 is a Class II device made by Corentec Co., Ltd, cleared under FDA 510(k) K110404 on 16 Feb 2012 and listed in FDA GUDID since 31 Jan 2018 (UDI-DI 08806373883156), active as of 23 Oct 2026. 2 FDA recalls are linked to it.

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

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

2 ongoing

This device is named in the recall

Documents

510(k) K110404

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08806373883156 UDI-DI Date31 Jan 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK110404 Date16 Feb 2012DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K110404 decided 16 Feb 2012 Active
  • FDA GUDID UDI-DI 08806373883156 listed 31 Jan 2018 Listed

Recalls

2 recalls · 2 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-1935-2024 FDA Class II initiated 29 Mar 2024
    • Ongoing Z-1934-2024 FDA Class II initiated 29 Mar 2024

    Due to unsupported 10 year expiration date.

Timeline

4 dated events

  1. Cleared FDA 510(k) K110404
  2. Listed FDA GUDID 08806373883156
  3. Recall initiated FDA recalls Z-1935-2024
  4. Recall initiated FDA recalls Z-1934-2024

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
LOSPA Knee System
Generic name
Knee femur prosthesis trial, reusable
Model / reference
01.62.007
Primary DI / UDI-DI
08806373883156
510(k) Number
FDA product code
JWH
GMDN term
Knee femur prosthesis trial, reusable
Device class
Class II
Regulation number
888.3560
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Knee femur prosthesis trial, reusable

Cleared under the same submission (K110404)

and 8 more cleared under K110404

Similar devices in this category

Other devices filed under Knee femur prosthesis trial, reusable.

Other devices from Corentec Co., Ltd

See all devices from Corentec Co., Ltd →

Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (11, all answered No)