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Orthopedic Salvage System (Oss) 9cm Cobalt - Chrome Tibial Bodies

by Biomet Manufacturing Corp

510(k) K083827

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

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 · Special NumberK083827 Date13 Feb 2009ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1114-2017 FDA Class II initiated 16 Dec 2016

    labeling for specific lots of the Standard OSS Modular Proximal Tibia incorrectly identifies the components as AVL Modular Proximal Tibia. The mislabeling could have the potential risks: A delay in surgery less than 30 minutes. Patient undergoes a revision with increased risk of infection.

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  • Withdrawn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

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