Review Panel
Orthopedic FDA 510(k) Clearances & Devices
- Cleared Devices
- 17,115
- Product Codes (page)
- 37
- Latest Decision
- 2024-06-26
Clearances · page 11 of 172
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K234059 | Forma Medical Optimal Plating System | Forma Medical, Inc. | HRS | Class II | 2024-06-26 |
| K232829 | Versalock Rib and Sternum Plates System | GM Dos Reis Industria e Comercio Ltda. | HRS | Class II | 2024-06-26 |
| K240259 | APEX 3D Total Ankle Replacement System | Paragon 28, Inc. | HSN | Class II | 2024-06-24 |
| K233259 | Xerosyn | Xerothera, Inc. | MQV | Class II | 2024-06-21 |
| K241117 | M6-C Single Use, Disposable Instrumentation | Spinal Kinetics / Orthofix / Seaspine | QLQ | Class II | 2024-06-21 |
| K241519 | Invictus® Small Stature Spinal Fixation System | Alphatec Spine, Inc. | NKB | Class II | 2024-06-21 |
| K240669 | ACTIFY 3D Total Knee System, ACTIFY Total Knee System | Globus Medical, Inc. | JWH | Class II | 2024-06-20 |
| K241466 | Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System; Reef L Interbody System; Reef TO/TA System; Meridian Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TO Interbody System; WaveForm TA Interbody System; WaveForm A Interbody System | SeaSpine Orthopedics Corporation | MAX | Class II | 2024-06-20 |
| K240613 | APTUS Elbow Dorsal Olecranon Plates | Medartis AG | HRS | Class II | 2024-06-20 |
| K241435 | Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one ULTRABRAID suture, blue; Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one ULTRABRAID suture, co-braid-blue; Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one MINITAPE suture, blue; Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one MINITAPE suture, co-braid-blue | Smith & Nephew, Inc. | MBI | Class II | 2024-06-20 |
| K240830 | Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody System; WaveForm TO Interbody System; WaveForm TA Interbody System; FORZA XP Expandable Spacer System; Shoreline ACS Interbody System; Shoreline RT Interbody System; Meridian Interbody System; WaveForm A Interbody System | Orthofix Medical, Inc. | MAX | Class II | 2024-06-20 |
| K240678 | ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM 3DP Technology | Depuy Ireland UC | MBH | Class II | 2024-06-18 |
| K233867 | Fitbone Trochanteric | Orthofix Srl | HSB | Class II | 2024-06-18 |
| K240815 | Arthrex Cannulated Screw System | Arthrex, Inc. | HWC | Class II | 2024-06-13 |
| K241034 | Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw System | Medacta International S.A. | PML | Class II | 2024-06-12 |
| K240876 | Identity Shoulder System | Zimmer, Inc. | MBF | Class II | 2024-06-12 |
| K230546 | SIGNEX | Osteonic Co., Ltd. | HRS | Class II | 2024-06-11 |
| K240963 | Spinal System | Teslake, Inc. | NKB | Class II | 2024-06-06 |
| K241262 | Baby Gorilla/Gorilla Plating System; Monster Screw System | Paragon 28, Inc. | HRS | Class II | 2024-06-05 |
| K233008 | Cannulated Headless Bone Screws | Aap Implantate AG | HWC | Class II | 2024-06-05 |
| K240505 | Eminent Spine SI Screw System | Eminent Spine, LLC | OUR | Class II | 2024-06-04 |
| K233971 | Arthrex AlloSync PushLock Suture Anchor | Arthrex, Inc. | MAI | Class II | 2024-06-04 |
| K241258 | Ingenix Spinal System | Ingenium Spine | NKB | Class II | 2024-06-04 |
| K240834 | EcoFit® short stem cementless cpTi | Implantcast GmbH | LZO | Class II | 2024-06-03 |
| K240947 | TENSOR® Suture Button System | Globus Medical, Inc. | HTN | Class II | 2024-06-03 |
| K241218 | Tyber Medical Anatomical Plating System | Tyber Medical, LLC | HRS | Class II | 2024-05-31 |
| K233025 | Revolution External Plating System | New Standard Device Dba Metalogix | KTT | Class II | 2024-05-30 |
| K240838 | Spectrum Spine Cervical Cage System | Spectrum Spine, Inc. | ODP | Class II | 2024-05-30 |
| K233674 | Freedom Wrist Arthroplasty System | Ascension Orthopedics, Inc. | JWJ | Class II | 2024-05-30 |
| K233481 | AltiVate Reverse® Glenoid | Encore Medical L.P. | PHX | Class II | 2024-05-29 |
| K240049 | LINK(TM) External Fixator | Metric Medical Devices, Inc. | KTT | Class II | 2024-05-29 |
| K241235 | Arthrex TightRope II | Arthrex, Inc. | MBI | Class II | 2024-05-29 |
| K240749 | PILLAR SA Ti Spacer System (82-XXX) | Orthofix, Inc. | MAX | Class II | 2024-05-28 |
| K233089 | NeoSpan® Compression Implant System | In2bones USA, LLC | HRS | Class II | 2024-05-24 |
| K240592 | Wolff's Law Anterior Cervical Plate System | Spinal Simplicity, LLC | KWQ | Class II | 2024-05-24 |
| K241396 | uCerv Flux-C 3D Porous Titanium Cervical Interbody | Ulrich Medical USA, Inc. | ODP | Class II | 2024-05-23 |
| K241014 | Biomet Kirschner Wires (K-Wires) | Biomet, Inc. | HTY | Class II | 2024-05-22 |
| K241143 | Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner | Materialise NV | QHE | Class II | 2024-05-22 |
| K241276 | Vector Pedicle Screw System | Innovasis, Inc. | NKB | Class II | 2024-05-20 |
| K241175 | MiRus MoRe Lumbar Plating System | MiRus, LLC | KWQ | Class II | 2024-05-17 |
| K233215 | icotec Anterior Cervical Plate System | Icotec AG | KWQ | Class II | 2024-05-17 |
| K240935 | ARENAL Anterior Cervical Plate System | Effortmed, LLC | KWQ | Class II | 2024-05-17 |
| K241043 | Augment Off-Axis Instrument System | Fix Surgical | PHX | Class II | 2024-05-15 |
| K240278 | Full Wedge Lateralized and Augmented Baseplates | Fx Shoulder USA, Inc. | PHX | Class II | 2024-05-15 |
| K240368 | E3D-A Interbody System | Evolution Spine | OVD | Class II | 2024-05-15 |
| K240699 | SCARLET® AC-Ti | Spineart SA | OVE | Class II | 2024-05-10 |
| K233967 | DePuy Synthes MatrixSTERNUM Fixation System | Synthes GmbH | HRS | Class II | 2024-05-09 |
| K240392 | JAZZ Spinal System | Implanet | NKB | Class II | 2024-05-06 |
| K240685 | Salvo® Spine System | Spine Wave, Inc. | NKB | Class II | 2024-05-06 |
| K233800 | Vertos mild Device Kit (MDK-0002) | Vertos Medical, Inc. | HRX | Class II | 2024-05-06 |
| K232733 | Mbrace Cable | Medacta International S.A. | JDQ | Class II | 2024-05-03 |
| K232941 | Megaloop Button System | Suzhou Endophix Co., Ltd. | MBI | Class II | 2024-05-03 |
| K232648 | RODEO Telescopic Nail | Orthofix Srl | HSB | Class II | 2024-05-03 |
| K240126 | ProAM ALIF System | Pro Surgical, Inc. | OVD | Class II | 2024-05-03 |
| K240621 | Morpheus® Moldable; Agilon® Moldable | Biogennix, LLC | MQV | Class II | 2024-04-30 |
| K240591 | restor3d Kinos Axiom Total Ankle System | Restor3D, Inc. | HSN | Class II | 2024-04-29 |
| K240526 | POWEReam Xia/Serrato | Stryker Instruments | NKB | Class II | 2024-04-29 |
| K240872 | Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation System | Clariance | NKB | Class II | 2024-04-26 |
| K240324 | EMPOWR Revision Symmetric Knee Cones | Encore Medical, L.P. (Dba Enovis) | JWH | Class II | 2024-04-26 |
| K233873 | XLO Brand of Locking Distal Humerus Plating System | Ortho Life Systems Private Limited | HRS | Class II | 2024-04-26 |
| K240566 | Reef L Interbody System; WaveForm L Interbody System | SeaSpine Orthopedics Corporation | MAX | Class II | 2024-04-26 |
| K240299 | Persona the Personalized Knee System (Persona OsseoTi 3-Peg Patella) | Zimmer, Inc. | MBH | Class II | 2024-04-26 |
| K240535 | Digital ClarusScope System; Digital NeuroPEN System | Clarus Medical, LLC | HRX | Class II | 2024-04-25 |
| K240846 | CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments; CarboClear® Hybrid Fenestrated Pedicle Screw System and High V+® Bone Cement; CarboClear® X Fenestrated Pedicle Screw System and High V+® Bone Cement | CarboFix Orthopedics , Ltd. | NKB | Class II | 2024-04-25 |
| K234056 | canturio® se (Canturio Smart Extension) | Canary Medical USA, LLC | QPP | Class II | 2024-04-24 |
| K234025 | 22.2mm BIOLOX® delta Ceramic V40 Femoral Heads | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | LZO | Class II | 2024-04-24 |
| K240623 | Omnia Medical TiBrid-SA System | Omnia Medical, LLC | OVD | Class II | 2024-04-24 |
| K231699 | QUANTUM® Patient Specific Instrumentation (PSI) System | In2bones Sas | HSN | Class II | 2024-04-23 |
| K233966 | Anterior Spine Truss System-Stand Alone (ASTS-SA) | 4Web Medical, Inc. | OVD | Class II | 2024-04-22 |
| K233311 | Acumed Wrist Plating System | Acumed, LLC | HRS | Class II | 2024-04-22 |
| K232149 | BowTie SI Joint Fusion System | Sail Fusion, LLC | OUR | Class II | 2024-04-20 |
| K230120 | KeYi Total Knee System | Beijing Keyi Medical Device Technology Co., Ltd. | JWH | Class II | 2024-04-19 |
| K234119 | UniSpace® Stand-Alone C Cage | Innosys Co., Ltd. | OVE | Class II | 2024-04-19 |
| K232566 | NewPort Spinal System; Daytona Small Stature Spinal System; Malibu Spinal System; Mariner Pedicle Screw Systems: Mariner Outrigger Revision System; Mariner MIS Pedicle Screw System; Mariner Deformity System; Mariner RDX System | SeaSpine Orthopedics Corporation | NKB | Class II | 2024-04-19 |
| K232259 | Patriot-SI Posterior Implant System | Spinal Simplicity, LLC | OUR | Class II | 2024-04-19 |
| K232105 | APTUS Foot System 2.8-3.5 | Medartis AG | HRS | Class II | 2024-04-19 |
| K240046 | Ethylene Oxide Sterilization Supplier Change for MPO Hips | Microport Orthopedics | LPH | Class II | 2024-04-18 |
| K233863 | TriMed ASET Foot Plating System (1ST MTP 9-hole Long Plate), TriMed ASET Foot Plating System (1st Met Osteotomy Plate), TriMed ASET Foot Plating System (H-Plate), TriMed ASET Foot Plating System (Talonavicular Plate), TriMed ASET Foot Plating System (Calcaneal Slide Osteotomy Plate), TriMed ASET Foot Plating System (Evans Osteotomy Plate), TriMed ASET Foot Plating System (Medial Column Fusion Plate), TriMed ASET Foot Plating System (Straight Plate), TriMed ASET Foot Plating System (T- | TriMed, Inc. | HRS | Class II | 2024-04-17 |
| K240484 | MSFX Mikron Cervical Anterior Plate System | Mikron Makina Sanayi VE Ticaret Ltd. Sti. | KWQ | Class II | 2024-04-17 |
| K232256 | Alcantara Thoracolumbar Plate System | Camber Spine Technologies, LLC | KWQ | Class II | 2024-04-16 |
| K232175 | XN Knee Prosthesis System | Beijing Chunlizhengda Medical Instruments Co., Ltd. | JWH | Class II | 2024-04-14 |
| K240452 | Ceramic Femoral Head | Microport Orthopedics, Inc. | LZO | Class II | 2024-04-12 |
| K240418 | Stryker Orthopaedics Hip Systems Labeling Update | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | JDI | Class II | 2024-04-12 |
| K240703 | Fine Osteotomy | Bodycad Laboratories, Inc. | HRS | Class II | 2024-04-12 |
| K240720 | TiLink-P SI Joint Fusion System | SurGenTec, LLC | OUR | Class II | 2024-04-11 |
| K240719 | OC JuggerKnot Soft Anchor | Riverpoint Medical | MBI | Class II | 2024-04-11 |
| K233509 | Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System, LABYRINTH System, Zavation ALIF System | Zavation Medical Products, LLC | MAX | Class II | 2024-04-10 |
| K240423 | TDM Anterior Cervical Plate System | Tdm Co., Ltd. | KWQ | Class II | 2024-04-08 |
| K232115 | TDM Large Bone Plate and Screw System | Tdm Co., Ltd. | HRS | Class II | 2024-04-05 |
| K234105 | Catalyst F1x Shoulder System | Catalyst Orthoscience, Inc. | PHX | Class II | 2024-04-05 |
| DEN220015 | Orthobond Mariner Pedicle Screw System | Orthobond Coporation | QZY | Class II | 2024-04-05 |
| K232792 | icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec ETurn TLIF Lumbar Cage) | Icotec AG | MAX | Class II | 2024-04-05 |
| K240737 | G Surgical Marksman MIS System | G Surgical, LLC | NKB | Class II | 2024-04-05 |
| DEN210058 | ELEOSx Limb Salvage System | Onkos Surgical | QZZ | Class II | 2024-04-05 |
| K232114 | TRIBRID® Unicompartmental Knee System | Kyocera Medical Technologies, Inc. | HSX | Class II | 2024-04-04 |
| K240639 | PINNACLETM Constrained Acetabular Liners | Depuy Ireland UC | KWZ | Class II | 2024-04-04 |
| K233910 | Vertex Hip Fracture Nailing System | Orthoxel Dac | HSB | Class II | 2024-04-04 |
| K232790 | KONG®-TL VBR System and KONG® C VBR System | Icotec AG | MQP | Class II | 2024-04-04 |
| K240350 | AnyPlus II Spinal Fixation System | GS Medical Co., Ltd. | NKB | Class II | 2024-04-03 |
| K240043 | EVOLUTION® Hinge Knee System;GUARDIAN limb Salvage System;DCW Modular Distal Femoral System;REPIPHYSIS Limb Salvage System;EVOLUTION® MP Total Knee System; EVOLUTION® MP Total Knee System; EVOLUTION® MP Adaptive CS Insert; EVOLUTION® MP Adaptive PS Tibial Insert; EVOLUTION® MP CS/CR Porous Femur/EVOLUTION® Adaptive CS and PS Inserts; EVOLUTION® Revision CCK System; ADVANCE® Double High Insert; ADVANCE® A-CLASS® Tibial Insert; ADVANCE® Knee System; ADVANCE® Ultra-Congruent Tibial Inse | Microport Orthopedics, Inc. | KRO | Class II | 2024-04-01 |
17,115 clearances in the Orthopedic panel. Data: openFDA.