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Link® Megasystem-C®

by WALDEMAR LINK GmbH & Co. KG

510(k) K151008

Link® Megasystem-C® is a Class II device made by WALDEMAR LINK GmbH & Co. KG, cleared under FDA 510(k) K151008 on 26 Aug 2015, active as of 22 Oct 2026. 14 FDA recalls are linked to it.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

16 ongoing

This device is named in the recall

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK151008 Date26 Aug 2015ClearedStatusActive

Official records

Recalls

16 recalls · 16 ongoing · FDA

  • 13 recalls, same reason

    • Ongoing Z-1512-2026 FDA Class II initiated 12 Jan 2026
    • Ongoing Z-1513-2026 FDA Class II initiated 12 Jan 2026
    • Ongoing Z-1518-2026 FDA Class II initiated 12 Jan 2026
    • Ongoing Z-1516-2026 FDA Class II initiated 12 Jan 2026
    • Ongoing Z-1522-2026 FDA Class II initiated 12 Jan 2026
    • Ongoing Z-1521-2026 FDA Class II initiated 12 Jan 2026
    • Ongoing Z-1520-2026 FDA Class II initiated 12 Jan 2026
    • Ongoing Z-1519-2026 FDA Class II initiated 12 Jan 2026
    • Ongoing Z-1517-2026 FDA Class II initiated 12 Jan 2026
    • Ongoing Z-1515-2026 FDA Class II initiated 12 Jan 2026
    • Ongoing Z-1523-2026 FDA Class II initiated 12 Jan 2026
    • Ongoing Z-1511-2026 FDA Class II initiated 12 Jan 2026
    • Ongoing Z-1514-2026 FDA Class II initiated 12 Jan 2026

    The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.

    • Ongoing Z-0890-2026 FDA Class II initiated 10 Nov 2025

    The device has been delivered with a preassembled locking screw that had been inserted from the wrong side into the male taper of the femoral component.

  • 2 recalls, same reason

    • Ongoing Z-2410-2024 FDA Class II initiated 22 May 2024 on shared 510(k) K151008
    • Ongoing Z-2411-2024 FDA Class II initiated 22 May 2024 on shared 510(k) K151008

    Blind screws of the modular tibial component cannot be loosened intraoperatively,prolongation surgery due to intraoperatively change in procedure, probably to cementing technique

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Timeline

17 dated events

  1. Recall initiated FDA recalls Z-1516-2026
  2. Recall initiated FDA recalls Z-1522-2026
  3. Recall initiated FDA recalls Z-1521-2026
  4. Recall initiated FDA recalls Z-1520-2026
  5. Recall initiated FDA recalls Z-1519-2026
  6. Recall initiated FDA recalls Z-1517-2026
  7. Recall initiated FDA recalls Z-1515-2026
  8. Recall initiated FDA recalls Z-1523-2026
  9. Recall initiated FDA recalls Z-1511-2026
  10. Recall initiated FDA recalls Z-1514-2026

7 earlier events are in the sections above.

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
KRO
Device class
Class II
Regulation
21 CFR Part 888.3510
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

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