HRSFDA Class 2 · 21 CFR 888.3030 · implantable
Plate, 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
1,306
Manufacturers
130
Flagged signals
18
Adverse-event reports
34,691
Code matrix
| FDA product code | HRS |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3030 |
| GMDN | 35359 |
| 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 | 2011 | 3 | 399.0 | 827 |
| Other | 2015 | 33 | 332.8 | 10,593 |
| Other | 2012 | 6 | 43.4 | 208 |
| Other | 2010 | 6 | 37.3 | 177 |
| Other | 2010 | 3 | 11.2 | 19 |
| Other | 2011 | 4 | 9.4 | 22 |
| Other | 2015 | 9 | 7.5 | 45 |
| Other | 2010 | 3 | 7.0 | 10 |
| Other | 2014 | 7 | 5.9 | 24 |
| Other | 2013 | 5 | 4.2 | 9 |
| Other | 2012 | 4 | 3.4 | 4 |
| Injury | 2011 | 10 | 2.6 | 14 |
| Injury | 2023 | 8 | 2.6 | 10 |
| Injury | 2016 | 4 | 2.6 | 4 |
| Injury | 2025 | 4 | 2.6 | 4 |
| Injury | 2024 | 4 | 2.6 | 4 |
| Injury | 2018 | 4 | 2.6 | 4 |
| Injury | 2014 | 10 | 2.2 | 8 |
Device-level recall linkage pending an FDA-recalls product-code re-ingest. Class 2 family · 34,691 total adverse-event reports.
Manufacturer landscape
| Manufacturer | Clearances | Latest | Concern |
|---|---|---|---|
| Synthes (Usa) | 87 | 2011 | — |
| Wrightmedicaltechnologyinc | 45 | 2021 | — |
| ARTHREX, INC. | 39 | 2026 | — |
| Smith & Nephew, Inc. | 34 | 2022 | — |
| Medartis AG | 30 | 2026 | — |
| aap Implantate AG | 25 | 2026 | — |
| Zimmer, Inc. | 25 | 2016 | — |
| TriMed, Inc. | 24 | 2026 | — |
| Jeil Medical Corporation | 24 | 2025 | — |
| NEWCLIP TECHNICS | 22 | 2026 | — |
| Stryker GmbH | 21 | 2024 | — |
| Biomet, Inc. | 20 | 2021 | — |
| Howmedica Corp. | 20 | 1998 | — |
| DEPUY ORTHOPAEDICS, INC. | 18 | 2012 | — |
| Howmedica Osteonics Corp. | 16 | 2010 | — |
| Synthes (USA) Products, LLC | 15 | 2021 | — |
| In2Bones USA, LLC | 15 | 2024 | — |
| Onyx Medical Corp. | 14 | 1994 | — |
| ORTHOPEDIATRICS CORP. | 12 | 2025 | — |
| KLS-Martin L.P. | 11 | 2026 | — |
| Skeletal Dynamics, Inc. | 11 | 2026 | — |
| Biomet Microfixation | 11 | 2024 | — |
| Tyber Medical, LLC | 10 | 2025 | — |
| Treace Medical Concepts, Inc. | 9 | 2024 | — |
| Bonebridge AG | 9 | 2026 | — |
Concern score lights up where a maker maps to a scored entity (depth fast-follow).
Recent FDA clearances
I.T.S. PRS Phoenix II · I.T.S. GmbH510(k) · 2026-04-24
POYA 3.5mm Medial Proximal Tibia System · Bonebridge AG510(k) · 2026-04-24
PC Fix System · Chest Wall Innovations, Inc.510(k) · 2026-04-24
SMART Osteotomy System · Actis Medical Pty., Ltd.510(k) · 2026-04-10
enHAnce PEEK Bunion System · Nvision Biomedical Technologies, Inc.510(k) · 2026-04-01
Airlock® Ankle Plating System · Novastep SAS510(k) · 2026-03-25
Vortex5 Tailor's Bunion Correction System · Nvision Biomedical Technologies, Inc.510(k) · 2026-03-25
LOQTEQ® VA Proximal Humerus Plate 3.5 · Aap Implantate AG510(k) · 2026-03-24
Clavicle Fixation System · Skeletal Dynamics, Inc.510(k) · 2026-03-23
CastleLoc Pectus Bar System · L&K BIOMED Co., Ltd.510(k) · 2026-03-19
Super Upper Limbs Versalock Plating System · GM Dos Reis Industria e Comercio Ltda.510(k) · 2026-03-17
APS Spear Locking Plate · A Plus Biotechnology Co., Ltd.510(k) · 2026-03-17
APTUS Shoulder Proximal Humerus System, PentaLock 3.5 · Medartis AG510(k) · 2026-03-16
Xpert Hand · Newclip Technics510(k) · 2026-03-11
DePuy Synthes VOLT Proximal Tibia 3.5 Plating System · Synthes GmbH510(k) · 2026-03-09
Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage Button · Arthrex, Inc.510(k) · 2026-03-03
VOLT Ankle Trauma 2.7/3.5 Plating System; VOLT Calcaneus 2.7 Plating System · Synthes GmbH510(k) · 2026-03-02
HKT Anatomical Locking Trauma System · Hankil Tech Medical Co., Ltd.510(k) · 2026-02-27
RIB LINK Fixation System · Globus Medical, Inc.510(k) · 2026-02-26
KLS Martin Ixos System · KLS Martin L.P.510(k) · 2026-02-20
KLS Martin Pure Pectus System · KLS-Martin L.P.510(k) · 2026-02-20
Wrist Fracture System · Met One Technologies, LLC510(k) · 2026-02-12
Arthrex Variable Angle (VA) Proximal Tibia Plating System · Arthrex, Inc.510(k) · 2026-01-21
TriMed Volar Bearing Plates (VBEAL-13-7S); TriMed Volar Bearing Plates (VBEAR-13-7S); TriMed Volar Bearing Plates (VBEAL-14-7S); TriMed Volar Bearing Plates (VBEAR-14-7S); TriMed Volar Bearing Plates (VBEAL-16-7S); TriMed Volar Bearing Plates (VBEAR-16-7S) · TriMed, Inc.510(k) · 2026-01-15
Arthrex Anatomic Lapidus Plates and I-Beam Lapidus Plates · Arthrex, Inc.510(k) · 2026-01-12
Sources: FDA 510(k)/PMA · openFDA MAUDE · FDA device classification · MedevIQ manufacturer-canonical. Registry data, AI-reviewed; expert clinical sign-off in progress.