HWCFDA Class 2 · 21 CFR 888.3040 · implantable
Screw, Fixation, Bone
Device family · Orthopedic
Automated profile from regulatory + adverse-event registries · AI-reviewed · expert clinical sign-off in progress — not yet independently verified.
FDA clearances
1,054
Manufacturers
125
Flagged signals
19
Adverse-event reports
50,854
Code matrix
| FDA product code | HWC |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3040 |
| GMDN | — (crosswalk pending) |
| Implantable | Yes |
| Life-sustaining | No |
Adverse-event signals
Public · always freeMAUDE disproportionality (PRR), flagged where PRR ≥ 2, χ² ≥ 4, count ≥ 3.
| Event type | Year | Reports | PRR | χ² |
|---|---|---|---|---|
| Other | 2015 | 6 | 221.7 | 1,108 |
| Other | 2013 | 3 | 90.7 | 184 |
| Other | 2011 | 25 | 66.0 | 1,538 |
| 2010 | 3 | 64.5 | 129 | |
| Other | 2013 | 5 | 35.8 | 136 |
| Other | 2010 | 3 | 21.5 | 40 |
| Other | 2014 | 3 | 21.5 | 40 |
| Other | 2010 | 4 | 14.6 | 38 |
| Other | 2010 | 5 | 13.2 | 45 |
| Other | 2010 | 5 | 13.2 | 45 |
| Other | 2012 | 3 | 13.0 | 22 |
| Other | 2013 | 5 | 8.7 | 27 |
| Other | 2014 | 4 | 6.9 | 15 |
| Injury | 2023 | 42 | 2.6 | 65 |
| Injury | 2011 | 5 | 2.6 | 6 |
| Death | 2021 | 10 | 2.6 | 8 |
| Injury | 2021 | 10 | 2.4 | 11 |
| Injury | 2021 | 13 | 2.3 | 13 |
| Injury | 2021 | 7 | 2.0 | 4 |
Device-level recall linkage pending an FDA-recalls product-code re-ingest. Class 2 family · 50,854 total adverse-event reports.
Manufacturer landscape
| Manufacturer | Clearances | Latest | Concern |
|---|---|---|---|
| ARTHREX, INC. | 44 | 2025 | — |
| Wrightmedicaltechnologyinc | 31 | 2021 | — |
| Synthes (Usa) | 30 | 2010 | — |
| Smith & Nephew, Inc. | 27 | 2023 | — |
| Biomet, Inc. | 24 | 2020 | — |
| Linvatec Corp. | 17 | 2005 | — |
| EXTREMITY MEDICAL, LLC | 16 | 2025 | — |
| Depuy, Inc. | 14 | 1998 | — |
| Zimmer, Inc. | 12 | 2015 | — |
| Depuy Mitek, A Johnson & Johnson Company | 12 | 2013 | — |
| Howmedica Corp. | 12 | 1998 | — |
| Onyx Medical Corp. | 11 | 1994 | — |
| Tyber Medical, LLC | 9 | 2026 | — |
| Nextremity Solutions, Inc. | 9 | 2022 | — |
| Acu Med, Inc. | 8 | 1996 | — |
| aap Implantate AG | 8 | 2024 | — |
| Osteonics Corp. | 8 | 1998 | — |
| FOURNITURES HOSPITALIERES INDUSTRIE | 8 | 2017 | — |
| Buckman Co., Inc. | 8 | 1998 | — |
| Stryker Endoscopy | 7 | 2007 | — |
| Medshape, Inc. | 6 | 2026 | — |
| Stryker GmbH | 6 | 2022 | — |
| Medartis AG | 6 | 2026 | — |
| Acufex Microsurgical, Inc. | 6 | 1996 | — |
| FUSION ORTHOPEDICS, LLC | 6 | 2021 | — |
Concern score lights up where a maker maps to a scored entity (depth fast-follow).
Recent FDA clearances
TITAN Nail; APTUS K-Wire System · Medartis AG510(k) · 2026-04-17
CoAptix S System · University of Utah, Department of Orthopaedics510(k) · 2026-04-10
Tyber Medical Trauma Screw · Tyber Medical, LLC510(k) · 2026-04-03
DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip Delta; DynaClip Quattro · MedShape, Inc.510(k) · 2026-03-18
Treace Medical Concepts (TMC) Screw Fixation System · Treace Medical Concepts, Inc.510(k) · 2026-03-06
Tyber Medical Trauma Screw · Tyber Medical, LLC510(k) · 2025-12-31
Ultra Compression Screw System · Pace Surgical510(k) · 2025-11-06
Eleganz IM Threaded Nail System (IM Threaded Nail System) · Dev4510(k) · 2025-10-10
MetaFore Small Screw System · Extremity Medical, LLC510(k) · 2025-10-08
Cannulated Screw and Kirschner (K wire) System · Orthonovis, Inc.510(k) · 2025-10-02
CurvaFix Low Profile System · Curvafix, Inc.510(k) · 2025-08-29
Phoenix Sinus Tarsi Stent System · Astra Orthomed, Inc.510(k) · 2025-08-27
Dunamis Screw and Suture Locking System · Dunamis Medical, LLC510(k) · 2025-08-15
Eleganz Fusion Screw System (Fusion Screw System) · Dev4510(k) · 2025-06-13
TriMed® Compression Screws · TriMed, Inc.510(k) · 2025-04-10
SnapHammer Hammertoe Correction System · Nvision Biomedical Technologies, Inc.510(k) · 2025-04-02
TITANEX Screw Systems · Vilex, LLC510(k) · 2025-03-05
Caliber Intramedullary Fixation System · Nvision Biomedical Technologies510(k) · 2025-02-05
Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw · Innovate Orthopaedics, Ltd.510(k) · 2025-01-31
Arthrex SS VAL and VAL KreuLock Compression Screw System · Arthrex, Inc.510(k) · 2025-01-10
Locking Screw,CoCrMo · Double Medical Technology, Inc.510(k) · 2024-12-04
OsteoCoil Nitinol Compression System (Multiple Component PNs) · Flower Orthopedics Corporation Dba Conventus Flower Ortho510(k) · 2024-11-22
Tigon Medical Fractures, Instability, and Reconstruction (FIRE) · Tigon Medical510(k) · 2024-10-29
OsteoCentric Technologies Cannulated Fasteners and Nuts · OsteoCentric Technologies510(k) · 2024-10-09
Treace Medical Concepts (TMC) Screw Fixation System · Treace Medical Concepts, Inc.510(k) · 2024-10-04
Sources: FDA 510(k)/PMA · openFDA MAUDE · FDA device classification · MedevIQ manufacturer-canonical. Registry data, AI-reviewed; expert clinical sign-off in progress.