CHARLOTTE CLAW 3.5— 510(k) K080295

Clearance details

Applicant

Wrightmedicaltechnologyinc

Product code

Code HRS

Device class

Class 2

Regulation

21 CFR 888.3030

Advisory panel

Orthopedic

Date received

2008-02-04

Decision date

2008-02-27

Decision

Substantially Equivalent

Clearance type

Special

Location

Arlington, TN, 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

• K222835 — Prophecy Preoperative Navigation Alignment System2023-01-27
• K213342 — PRO-DENSE LoVisc Bone Graft Substitute2022-01-05
• 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-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 K080295.