REDUCE FRACTURE PLATING SYSTEM LINE EXTENSION— 510(k) K142135

Clearance details

Applicant

Icon Orthopedic Concepts, LLC Dba Edge Orthopaedic

Product code

Code HRS

Device class

Class 2

Regulation

21 CFR 888.3030

Advisory panel

Orthopedic

Date received

2014-08-04

Decision date

2014-08-28

Decision

Substantially Equivalent

Clearance type

Special

Location

Boonton, NJ, 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

• K140876 — VIEW PLATING SYSTEM,REDUCE FRACTURE PLATING SYSTEM,BONE SCREW2014-07-22

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-2116-2018 — Rival Reduce Kit Locking and Non-Locking Screw D 2.0MM, D 2.7MM, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Part Number: 000-K-011CClass II·Terminated·Orthofix, Inc·20180406
• Z-2117-2018 — Rival View Kit Locking and Non-Locking Screw D 2.7MM, D 3.2MM, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Part Number: 000-K-009CClass II·Terminated·Orthofix, Inc·20180406
• Z-2118-2018 — Rival Reduce Kit Plates, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Part Number: 000-K-012CClass II·Terminated·Orthofix, Inc·20180406
• Z-2125-2018 — Box Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) 18MM (003-F-18001); b) 22MM (003-F-22001); c) 30MM (003-F-30001)Class II·Terminated·Orthofix, Inc·20180406
• Z-2128-2018 — H-Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) 12MM Spacer (003-H-12001); b) 15MM Spacer (003-H-15001); 20MM Spacer (003-H-20001); 25MM Spacer (003-H-25001); 30 MM (003-H-30001)Class II·Terminated·Orthofix, Inc·20180406

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K142135.