TMZF PRESS FIT HA STEM AND TMZF PRESS FIT PLUS HA STEM— 510(k) K994366

Clearance details

Applicant

Howmedica Osteonics Corp.

Product code

Code MEH

Device class

Class 2

Regulation

21 CFR 888.3353

Advisory panel

Orthopedic

Date received

1999-12-27

Decision date

2000-03-16

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Rutherford, NJ, US

• K261576 — Icona Hip Stem2026-08-10
• K250375 — Allure Hip Stem and Intramedullary Plugs2025-11-05
• K251166 — Mfinity Femoral System2025-06-13
• K251052 — Trivicta® Hip Stem2025-05-22
• K242315 — Resolve Modular Revision Hip Stem2025-05-01

• K193429 — Exeter V40 Femoral Stem, Exeter X3 RimFit Cup2020-08-13
• K200782 — Triathlon Posterior Stabilized Femoral Component - beaded with Peri-Apatite, Triathlon Cruciate Retaining Femoral Component - beaded with Peri-Apatite2020-05-13
• K130895 — REUNION RSA SHOULDER SYSTEM2013-12-27
• K123604 — ABG III MONOLITHIC HIP STEM2013-08-16
• K122015 — DISTAL FEMORAL GROWING PROSTHESIS, TIBIAL ROTATING COMPONENTS, BEARING, AXIS, CIRCLIP, WEDGE2013-02-22

Injury

2,021

Total

2,021

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-0656-2013 — Accolade TMZF Plus 127 degree Neck Angle V40 Hip Stem #2.5 and Accolade TMZF Plus 127 degree Neck Angle V40 Hip Stem #3.5, Howmedica Osteonics Corp. The intended use is for reconstruction of the head and neck of the femoral joint.Class II·Terminated·Stryker Howmedica Osteonics Corp.·20121023

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K994366.