EPOCA CODR STEM AND HEAD— 510(k) K014049

Clearance details

Applicant

Stelkast Company

Product code

Code KWT

Device class

Class 2

Regulation

21 CFR 888.3650

Advisory panel

Orthopedic

Date received

2001-12-10

Decision date

2002-01-09

Decision

Substantially Equivalent

Clearance type

Special

Location

Pittsburgh, PA, US

• K262173 — N22 Offset Humeral Head2026-09-08
• K250713 — Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder Implants2025-12-01
• K251686 — Tornier Humeral Reconstruction System Max (Tornier HRS Max)2025-10-30
• K241944 — AGILON® XO Shoulder Replacement System2025-03-10
• K241817 — InSet Total Shoulder System2025-02-11

• K122883 — EXP TIBIAL INSERTS AND PATELLAR COMPONENTS FOR THE PROVEN GEN-FLEX TOTAL KNEE SYSTEM2013-08-05
• K122773 — CROSS-OVER ACETABULAR SHELL & LINER2012-10-09
• K094035 — EXP ACETABULAR LINER, MODELS SC3342 NON-HOODED 28MM, SC3343 HOODED 28MM2011-03-24
• K081458 — PROVEN STEM EXTENDER2008-06-06
• K063211 — PROVEN KNEE SYSTEM HIGH FLEXION TIBIAL INSERT2007-01-18

Injury

2,467

Other

2

Total

2,469

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 →