CLAW II POLYAXIAL COMPRESSION SYSTEM AND ORTHOLOC 3DSI LOCKING SCREWS— 510(k) K113014

Clearance details

Applicant

Wrightmedicaltechnologyinc

Product code

Code HRS

Device class

Class 2

Regulation

21 CFR 888.3030

Advisory panel

Orthopedic

Date received

2011-10-11

Decision date

2012-01-31

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Arlington, TN, US

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• K212996 — Sterile PHALINX Hammertoe System2021-11-16
• K202815 — PROPHECY Preoperative Navigation Alignment System2021-03-10
• K201259 — ORTHOLOC 2 with 3Di Technology Pilon Fracture Plating System2021-01-08

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-1169-2023 — ORTHOLOC 3DSi CLAW II 4 HOLE Plate, Size 25MM, REF 402S0425, Bone fixation deviceClass II·Ongoing·Wright Medical Technology, Inc.·20230202
• Z-1170-2023 — ORTHOLOC 3DSi CLAW II 4 HOLE Plate, Size 25MM, REF 40241425, Bone fixation deviceClass II·Ongoing·Wright Medical Technology, Inc.·20230202
• Z-0392-2022 — Stryker CLAW II ORTHOLOC 3DSi Plate, Hole Qty: 4, 30mm, REF 40240430.Class II·Ongoing·Wright Medical Technology Inc·20211203
• Z-2599-2014 — CLAW PLATE 20mm INTERAXIS CHARLOTTE F&A SYSTEM, REF 40S20020, 1 EACH, Rx ONLY, NON STERILE OrthopedicClass II·Terminated·Wright Medical Technology, Inc.·20140730
• Z-2600-2014 — CLAW 3.5mm PLATE CHARLOTTE F&A SYSTEM, SIZE 30mm, 2 HOLE, USE WITH 3.5mm CLAW SCREW, REF 4013-0130, 1 EACH, Rx ONLY, NON STERILE OrthopedicClass II·Terminated·Wright Medical Technology, Inc.·20140730
• Z-2601-2014 — CLAW II 2 HOLE PLATE ORTHOLOC 3DSi, LENGTH 15mm, REF 40240215, 1 EACH, Rx ONLY, NON STERILE OrthopedicClass II·Terminated·Wright Medical Technology, Inc.·20140730
• Z-2602-2014 — CLAW II 2 HOLE PLATE ORTHOLOC 3DSi, LENGTH 20mm, REF 40240220, 1 EACH, Rx ONLY, NON STERILE OrthopedicClass II·Terminated·Wright Medical Technology, Inc.·20140730
• Z-2603-2014 — CLAW II 2 HOLE PLATE ORTHOLOC 3DSi, LENGTH 25mm, REF 40240225, 1 EACH, Rx ONLY, NON STERILE OrthopedicClass II·Terminated·Wright Medical Technology, Inc.·20140730
• Z-2604-2014 — CLAW II 2 HOLE PLATE ORTHOLOC 3DSi, LENGTH 30mm, REF 40240230, 1 EACH, Rx ONLY, NON STERILE OrthopedicClass II·Terminated·Wright Medical Technology, Inc.·20140730
• Z-2605-2014 — CLAW II STRAIGHT PLATE ORTHOLOC 3DSi, LENGTH 20mm x 20mm, REF 40242020, 1 EACH, Rx ONLY, NON STERILE OrthopedicClass II·Terminated·Wright Medical Technology, Inc.·20140730
• Z-2607-2014 — CLAW II STRAIGHT PLATE ORTHOLOC 3DSi, LENGTH 25mm x 25mm, REF 40242525, 1 EACH, Rx ONLY, NON STERILE OrthopedicClass II·Terminated·Wright Medical Technology, Inc.·20140730
• Z-2608-2014 — CLAW II STRAIGHT PLATE ORTHOLOC 3DSi, LENGTH 20mm x 25mm, REF 40242025, 1 EACH, Rx ONLY, NON STERILE OrthopedicClass II·Terminated·Wright Medical Technology, Inc.·20140730

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K113014.