TIBIAL BASEPLATE AUGMENT MODEL KC-22118, KC-22128, KC-22138, KC-22148, KC-22158— 510(k) K094017

Clearance details

Applicant

Omni Life Science, Inc.

Product code

Code JWH

Device class

Class 2

Regulation

21 CFR 888.3560

Advisory panel

Orthopedic

Date received

2009-12-29

Decision date

2010-03-05

Decision

Substantially Equivalent

Clearance type

Special

Location

Raynham, MA, US

• K260063 — GSPE Spacer2026-09-11
• K262293 — EVOLUTION MPX Total Knee System2026-09-10
• K262341 — b-ONE® Mobio Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem Extensions2026-09-08
• K262130 — ATTUNE Revision Knee System2026-09-04
• K253961 — SK Knee System2026-09-01

• K191765 — OMNI TiN Coated Apex Knee System2019-09-25
• K152919 — OMNI Skirted Heads2016-03-10
• K131472 — APEX KNEE MODULAR TIBIA SYSTEM2013-10-08
• K112891 — APEX REVISION KNEE SYSTEMS2012-02-29
• K113242 — APEX ARC HIP STEM2012-01-05

Death

26

Injury

51,564

Malfunction

9,725

Other

9

Total

61,324

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-2370-2012 — Omnilife Science Apex Knee System Modular Tibia Augment, Size 1 x 4mm Ref: KC-54010. The Apex Knee System is intended for use as a primary or revision total knee replacement.Class II·Terminated·Omni Life Science·20120809
• Z-2371-2012 — Omnilife Science Apex Knee System Modular Tibia Augment, Size 2 x 4mm Ref: KC-54020. The Apex Knee System is intended for use as a primary or revision total knee replacement.Class II·Terminated·Omni Life Science·20120809
• Z-2372-2012 — Omnilife Science Apex Knee System Modular Tibia Augment, Size 3 x 4mm Ref: KC-54030. The Apex Knee System is intended for use as a primary or revision total knee replacement.Class II·Terminated·Omni Life Science·20120809
• Z-2373-2012 — Omnilife Science Apex Knee System Modular Tibia Augment, Size 4 x 4mm Ref: KC-54040. The Apex Knee System is intended for use as a primary or revision total knee replacement.Class II·Terminated·Omni Life Science·20120809
• Z-2374-2012 — Omnilife Science Apex Knee System Modular Tibia Augment, Size 5 x 4mm Ref: KC-54050. The Apex Knee System is intended for use as a primary or revision total knee replacement.Class II·Terminated·Omni Life Science·20120809
• Z-2375-2012 — Omnilife Science Apex Knee System Modular Tibia Augment, Size 6 x 4mm Ref: KC-54060. The Apex Knee System is intended for use as a primary or revision total knee replacement.Class II·Terminated·Omni Life Science·20120809

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K094017.