Apex Revision Knee System— 510(k) K153437

Clearance details

Applicant

Omnilife Science

Product code

Code JWH

Device class

Class 2

Regulation

21 CFR 888.3560

Advisory panel

Orthopedic

Date received

2015-11-27

Decision date

2015-12-21

Decision

Substantially Equivalent

Clearance type

Special

Location

East Taunton, 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

• K201611 — Apex Knee System2021-04-02
• K172467 — OMNI ARC Anteverted Neck Hip Stem2017-12-21
• K171156 — OMNI Anseris Hip Stem2017-08-17
• K163332 — Apex Revision Knee System2017-04-26
• K133381 — OMNI ARC MONOBLOCK HIP STEM2014-03-13

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-2069-2025 — Apex Knee System. Model Numbers: KC-50090, KC-50097, KC-50110, KC-50117, KC-50130, KC-50135, KC-50137, KC-50150, KC-50155, KC-50157, KC-50170, KC-50175, KC-50177, KC-50190, KC-50197, KC-52104, KC-52554, KC-52574, KC-52774, KC-55223, KC-55243Class II·Ongoing·CORIN MEDICAL, LTD.·20250523

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K153437.