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LOSPA Modular Knee System

by Corentec Co., Ltd

510(k) K160157

Active United States

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

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK160157 Date1 Dec 2016ClearedStatusActive

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.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
JWH
FDA applicant
Corentec Co., Ltd.
Device class
Class II
Regulation
21 CFR Part 888.3560
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The LOSPA Modular Knee System is a modular knee prosthesis designed for total knee arthroplasty, featuring a femoral component with a single-axis design for enhanced articular stability and range of motion. It includes a posterior-stabilized (PS) version with an intercondylar cam to minimize dislocation risk in deep flexion, along with a sphere-shaped articular surface to reduce contact stress and improve stability.

This system is supplied as a modular implant set, intended for use in orthopedic surgical procedures under sterile conditions. It is classified under FDA product code JWH and has received a Traditional 510(k) clearance via the Orthopedic (OR) Advisory Committee. The device is reusable through sterilization processes and must be handled according to standard orthopedic implant protocols.

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Questions

AI-generated answers, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What types of knee replacements does the LOSPA Modular Knee System support, and how does the design help with movement and stability during surgery?

    The LOSPA Modular Knee System supports total knee arthroplasty with two key designs: a standard single-axis femoral component and a posterior-stabilized (PS) version. The PS version includes an intercondylar cam to reduce dislocation risk during deep flexion, while the sphere-shaped articular surface in both versions minimizes contact stress and enhances overall stability and range of motion.

  • Is the LOSPA Modular Knee System intended for single-use or can it be reused after sterilization? How should it be handled to ensure safety?

    The LOSPA Modular Knee System is designed for reuse through sterilization processes. To ensure safety, it must be handled according to standard orthopedic implant protocols, including proper cleaning, sterilization, and storage to maintain sterility and integrity before surgical use.

  • What regulatory pathway was followed for the LOSPA Modular Knee System, and which advisory committee reviewed its submission?

    The LOSPA Modular Knee System received a Traditional 510(k) clearance through the FDA’s Orthopedic (OR) Advisory Committee. The submission was classified under product code JWH and was determined to be substantially equivalent to a predicate device, as indicated by the decision code SESE.

  • How is the LOSPA Modular Knee System supplied, and what precautions should be taken during storage?

    The LOSPA Modular Knee System is supplied as a modular implant set, intended for use in sterile surgical conditions. While specific storage instructions aren’t detailed, standard orthopedic implant protocols—such as protecting from contamination, moisture, and physical damage—should be followed to preserve sterility and functionality until use.