Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
HRS — Predicate Candidate Screening
1,320 FDA 510(k) clearances under this product code; the 50 most recent screened below.
86 daysmedian FDA review time
252 days90th percentile
1,320clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261511 | Xpert Ankle | Newclip Technics | 2026-07-28 | 82 | 0 |
| K261406 | Versalock Proximal Tibial Plating System | GM Dos Reis Industria e Comercio Ltda. | 2026-07-21 | 83 | 0 |
| K262032 | TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed No | TriMed, Inc. | 2026-07-16 | 29 | 0 |
| K261191 | Alians Elbow S | Newclip Technics | 2026-07-08 | 86 | 0 |
| K261054 | RibPlate System | Stryker Leibinger GmbH & Co KG | 2026-07-01 | 92 | 0 |
| K261351 | SALGINA 2.5mm Distal Radius System | Bonebridge AG | 2026-06-26 | 63 | 0 |
| K260958 | I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar | I.T.S. GmbH | 2026-06-16 | 85 | 0 |
| K261207 | Exalta Proximal Tibia Plating System | Tyber Medical, LLC | 2026-06-12 | 60 | 0 |
| K260761 | APTUS Clavicle System 2.8 | Medartis AG | 2026-06-05 | 88 | 0 |
| K261002 | Pectus Blu System | Biomet Microfixation | 2026-06-02 | 68 | 0 |
| K261038 | Xpert PFP | Newclip Technics | 2026-05-29 | 60 | 0 |
| K261145 | Avanti Distal Elbow ORIF System | Avanti Orthopaedics, LLC | 2026-05-09 | 32 | 0 |
| K260323 | OrthoPediatrics® Locking Cannulated Blade Plate System | OrthoPediatrics Corp. | 2026-04-30 | 90 | 0 |
| K260411 | PC Fix System | Chest Wall Innovations, Inc. | 2026-04-24 | 74 | 0 |
| K260054 | I.T.S. PRS Phoenix II | I.T.S. GmbH | 2026-04-24 | 106 | 0 |
| K260228 | POYA 3.5mm Medial Proximal Tibia System | Bonebridge AG | 2026-04-24 | 88 | 0 |
| K260090 | SMART Osteotomy System | Actis Medical Pty., Ltd. | 2026-04-10 | 88 | 0 |
| K253718 | enHAnce PEEK Bunion System | Nvision Biomedical Technologies, Inc. | 2026-04-01 | 128 | 0 |
| K260274 | Airlock® Ankle Plating System | Novastep SAS | 2026-03-25 | 55 | 0 |
| K260291 | Vortex5 Tailor's Bunion Correction System | Nvision Biomedical Technologies, Inc. | 2026-03-25 | 55 | 0 |
| K254253 | LOQTEQ® VA Proximal Humerus Plate 3.5 | Aap Implantate AG | 2026-03-24 | 85 | 0 |
| K254288 | Clavicle Fixation System | Skeletal Dynamics, Inc. | 2026-03-23 | 82 | 0 |
| K260448 | CastleLoc Pectus Bar System | L&K BIOMED Co., Ltd. | 2026-03-19 | 36 | 0 |
| K254053 | APS Spear Locking Plate | A Plus Biotechnology Co., Ltd. | 2026-03-17 | 90 | 0 |
| K260390 | Super Upper Limbs Versalock Plating System | GM Dos Reis Industria e Comercio Ltda. | 2026-03-17 | 39 | 0 |
| K253916 | APTUS Shoulder Proximal Humerus System, PentaLock 3.5 | Medartis AG | 2026-03-16 | 98 | 0 |
| K253906 | Xpert Hand | Newclip Technics | 2026-03-11 | 96 | 0 |
| K254093 | DePuy Synthes VOLT™ Medial Distal Femur 3.5 Plating System | Synthes GmbH | 2026-03-10 | 81 | 0 |
| K260069 | DePuy Synthes VOLT™ Proximal Tibia 3.5 Plating System | Synthes GmbH | 2026-03-09 | 59 | 0 |
| K260353 | Arthrex Humeral Plating System (Anatomic Humeral Plate) and | Arthrex, Inc. | 2026-03-03 | 28 | 0 |
| K254054 | VOLT™ Ankle Trauma 2.7/3.5 Plating System; VOLT™ Calcaneus 2 | Synthes GmbH | 2026-03-02 | 75 | 0 |
| K254249 | HKT Anatomical Locking Trauma System | Hankil Tech Medical Co., Ltd. | 2026-02-27 | 60 | 0 |
| K252166 | RIB LINK™ Fixation System | Globus Medical, Inc. | 2026-02-26 | 231 | 0 |
| K253660 | KLS Martin Pure Pectus System | KLS-Martin L.P. | 2026-02-20 | 92 | 0 |
| K254162 | KLS Martin Ixos System | KLS Martin L.P. | 2026-02-20 | 60 | 0 |
| K251732 | Wrist Fracture System | Met One Technologies, LLC | 2026-02-12 | 251 | 0 |
| K253713 | Arthrex Variable Angle (VA) Proximal Tibia Plating System | Arthrex, Inc. | 2026-01-21 | 58 | 0 |
| K254002 | TriMed Volar Bearing Plates (VBEAL-13-7S); TriMed Volar Bear | TriMed, Inc. | 2026-01-15 | 31 | 0 |
| K252807 | Arthrex Anatomic Lapidus Plates and I-Beam Lapidus Plates | Arthrex, Inc. | 2026-01-12 | 131 | 0 |
| K253178 | TRILEAP Plating System | Crossroads Extremity Systems | 2026-01-06 | 102 | 0 |
| K251050 | Pectus Versa System | Gm Dos Reis Industria E Comercio | 2025-12-19 | 260 | 0 |
| K252191 | BRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal Humerus | Bonebridge AG | 2025-12-17 | 156 | 0 |
| K252997 | HyperFlex® Bunion Correction System | Hyperflex Medical | 2025-12-11 | 84 | 0 |
| K250988 | KLS Martin Pure Pectus System | KLS-Martin L.P. | 2025-12-11 | 255 | 0 |
| K252897 | APS Osteotomy Fixation System (0945-1302-xx /4.5mm Cortex Sc | A Plus Biotechnology Co., Ltd. | 2025-12-11 | 91 | 0 |
| K252661 | SternaFuse Ti Fixation System | Fusion Innovations, LLC | 2025-11-19 | 89 | 0 |
| K253423 | ToeJack MIS Bunion System | Nvision Biomedical Technologies, Inc. | 2025-11-18 | 54 | 0 |
| K250865 | KLS Martin IPS Forearm System | KLS-Martin L.P. | 2025-11-14 | 238 | 0 |
| K252949 | Geminus Volar Distal Radius Plating System | Skeletal Dynamics, Inc. | 2025-11-13 | 58 | 0 |
| K252959 | WRISTAR MultiAx Distal Radius Kit | Intrauma S.P.A | 2025-11-12 | 57 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda