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Sled Unicompartment Knee System

by Link America, Inc.

510(k) K954186

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

32 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 NumberK954186 Date26 Jan 1996ClearedStatusActive

Recalls

32 recalls · 32 ongoing · FDA

  • 32 recalls, same reason

    • Ongoing Z-1508-2023 FDA Class II initiated 21 Mar 2023
    • Ongoing Z-1534-2023 FDA Class II initiated 21 Mar 2023
    • Ongoing Z-1536-2023 FDA Class II initiated 21 Mar 2023
    • Ongoing Z-1538-2023 FDA Class II initiated 21 Mar 2023
    • Ongoing Z-1524-2023 FDA Class II initiated 21 Mar 2023
    • Ongoing Z-1522-2023 FDA Class II initiated 21 Mar 2023
    • Ongoing Z-1529-2023 FDA Class II initiated 21 Mar 2023
    • Ongoing Z-1531-2023 FDA Class II initiated 21 Mar 2023
    • Ongoing Z-1512-2023 FDA Class II initiated 21 Mar 2023
    • Ongoing Z-1507-2023 FDA Class II initiated 21 Mar 2023
    • Ongoing Z-1526-2023 FDA Class II initiated 21 Mar 2023
    • Ongoing Z-1515-2023 FDA Class II initiated 21 Mar 2023
    • Ongoing Z-1511-2023 FDA Class II initiated 21 Mar 2023
    • Ongoing Z-1537-2023 FDA Class II initiated 21 Mar 2023
    • Ongoing Z-1532-2023 FDA Class II initiated 21 Mar 2023
    • Ongoing Z-1514-2023 FDA Class II initiated 21 Mar 2023
    • Ongoing Z-1528-2023 FDA Class II initiated 21 Mar 2023
    • Ongoing Z-1527-2023 FDA Class II initiated 21 Mar 2023
    • Ongoing Z-1513-2023 FDA Class II initiated 21 Mar 2023
    • Ongoing Z-1510-2023 FDA Class II initiated 21 Mar 2023
    • Ongoing Z-1530-2023 FDA Class II initiated 21 Mar 2023
    • Ongoing Z-1520-2023 FDA Class II initiated 21 Mar 2023
    • Ongoing Z-1525-2023 FDA Class II initiated 21 Mar 2023
    • Ongoing Z-1509-2023 FDA Class II initiated 21 Mar 2023
    • Ongoing Z-1517-2023 FDA Class II initiated 21 Mar 2023
    • Ongoing Z-1516-2023 FDA Class II initiated 21 Mar 2023
    • Ongoing Z-1521-2023 FDA Class II initiated 21 Mar 2023
    • Ongoing Z-1518-2023 FDA Class II initiated 21 Mar 2023
    • Ongoing Z-1523-2023 FDA Class II initiated 21 Mar 2023
    • Ongoing Z-1535-2023 FDA Class II initiated 21 Mar 2023
    • Ongoing Z-1533-2023 FDA Class II initiated 21 Mar 2023
    • Ongoing Z-1519-2023 FDA Class II initiated 21 Mar 2023

    Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant caused by suboptimal positioning of the implant or inadequate cementing technique leading to an unsatisfactory surgical result, and in the worst case, intervention or revision earlier than expected

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
HSX
Device Class
Class II
Regulation
21 CFR Part 888.3520
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

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