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LOSPA Knee System KD.SFT.0305

by Corentec Co., Ltd

LOSPA Knee System KD.SFT.0305 is a Class II device made by Corentec Co., Ltd, cleared under FDA 510(k) K160157 on 1 Dec 2016 and listed in FDA GUDID since 31 Jan 2018 (UDI-DI 08800017272368), 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) K160157

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 Number08800017272368 UDI-DI Date31 Jan 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK160157 Date1 Dec 2016DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K160157 decided 1 Dec 2016 Active
  • FDA GUDID UDI-DI 08800017272368 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) K160157
  2. Listed FDA GUDID 08800017272368
  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  • Withdrawn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
KD.SFT.0305
Primary DI / UDI-DI
08800017272368
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 (K160157)

and 8 more cleared under K160157

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)