NORMED ANKLE FIX SYSTEM 4.0 AND NORMED ANKLE FIX PLUS SYSTEM 4.0— 510(k) K123347

Clearance details

Applicant

Normed Medizin-Technik GmbH

Product code

Code HRS

Device class

Class 2

Regulation

21 CFR 888.3030

Advisory panel

Orthopedic

Date received

2012-10-31

Decision date

2013-08-02

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Austin, TX, US

• K261647 — Tempo Plating System; Ultra Compression Screw System2026-09-03
• K261830 — FRAXION 3.5 Plate System (Various - See Catalog) +3 more2026-08-28
• K262537 — Versalock Sterile Plating System2026-08-19
• K260277 — MIKRON TRAUMA BONE PLATE& SCREW SYSTEM2026-08-13
• K261511 — Xpert Ankle2026-07-28

• K151708 — RECON system - Compression Screws2016-03-02
• K151701 — Tenodesis screw system2016-01-26
• K152256 — RECON system- Grubber Lapidus-, Platar Lapidus-, Tarsalis Plates and Screws2015-11-05
• K152312 — RECON system-V-TEK-IVP Plates and Screws2015-10-30
• K152142 — RECON system - MPJ-Plates2015-09-16

Death

27

Injury

10,340

Malfunction

3,328

Total

13,695

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-1433-2019 — Drill, 2.7x125mm, AO, Item Number 502015217Class II·Terminated·Zimmer GmbH·20190408
• Z-1451-2019 — Drill, 3.2x145mm, AO, Item Number 502015650Class II·Terminated·Zimmer GmbH·20190408

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K123347.