Review Panel
Orthopedic FDA 510(k) Clearances & Devices
- Cleared Devices
- 17,115
- Product Codes (page)
- 41
- Latest Decision
- 2024-04-01
Clearances · page 12 of 172
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K240442 | MagnetOs Putty | Kuros Biosciences B.V | MQV | Class II | 2024-04-01 |
| K240288 | SF Push- in Anchor | Surgical Fusion Technologies GmbH | MAI | Class II | 2024-04-01 |
| K233989 | CarboClear® Posterior Cervical Screw System | CarboFix Orthopedics , Ltd. | NKG | Class II | 2024-03-27 |
| K233951 | CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw) | Medtronic Sofamor Danek USA, Inc. | NKB | Class II | 2024-03-27 |
| K234150 | Lucent® XP | Spinal Elements | MAX | Class II | 2024-03-27 |
| K240594 | Grappler Suture Anchor R3FLEX IOL System | Paragon 28, Inc. | MBI | Class II | 2024-03-26 |
| K233919 | VariAx 2 Distal Radius System | Stryker GmbH | HRS | Class II | 2024-03-25 |
| K240715 | Idys® C ZP 3DTi | Clariance | OVE | Class II | 2024-03-22 |
| K232282 | aprevo® anterior and lateral lumbar interbody fusion device, aprevo® transforaminal lumbar interbody fusion device | Carlsmed, Inc. | MAX | Class II | 2024-03-22 |
| K240690 | STRUXXURE® MCS Anterior Cervical Plate System | Nexxt Spine | KWQ | Class II | 2024-03-22 |
| K232169 | FITBONE® Transport and Lengthening System | Orthofix Srl | HSB | Class II | 2024-03-22 |
| K233148 | Augment Off-Axis Instrument System | Fix Surgical | PHX | Class II | 2024-03-22 |
| K234062 | APTUS Hand Scaphoid Plates | Medartis AG | HRS | Class II | 2024-03-21 |
| K233665 | DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT Small Fragment Plating System | DePuy Synthes | HRS | Class II | 2024-03-21 |
| K230088 | Ankle Truss System (ATS) | 4Web Medical, Inc. | SAI | Class II | 2024-03-21 |
| K233980 | ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation System, Sigma High Performance (HP) Partial Knee System | Depuy Ireland UC | KRO | Class II | 2024-03-21 |
| K240530 | DynaNail Mini Tapered Hybrid | MedShape, Inc. | HWC | Class II | 2024-03-21 |
| K233375 | Tranquil-L Interbody System | Nexus Spine, LLC | MAX | Class II | 2024-03-20 |
| K240507 | NuVasive AttraX Scaffold | Nuvasive, Inc. | MQV | Class II | 2024-03-20 |
| K232619 | MATRIX HA PEEK Cervical IBF System | Sapphire Medical Group | ODP | Class II | 2024-03-19 |
| K240113 | CORIOGRAPH Knee Pre-Op Plan | Smith & Nephew, Inc. | PBF | Class II | 2024-03-18 |
| K240515 | uNion® MAX Cervical Plate System | Ulrich Medical USA, Inc. | KWQ | Class II | 2024-03-18 |
| K240441 | MILAGRO Interference Screw; MILAGRO ADVANCE Interference Screw | Depuy Mitek | MAI | Class II | 2024-03-15 |
| K240539 | Vital Spinal Fixation System | Zimvie Spine (Zimmer Biomet Spine, Inc.) | NKB | Class II | 2024-03-15 |
| K231850 | QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® Instruments | Globus Medical, Inc. | NKG | Class II | 2024-03-14 |
| K234008 | CERAMENT G | Bonesupport AB | QRR | Class II | 2024-03-13 |
| K233592 | BioPoly Radial Head Implant | BioPoly, LLC | KWI | Class II | 2024-03-13 |
| K233949 | ACCORD Cable System | Smith & Nephew, Inc. | JDQ | Class II | 2024-03-13 |
| K240416 | Tranquil-C Interbody System | Nexus Spine, LLC | ODP | Class II | 2024-03-12 |
| K240424 | Mineral Collagen Composite Bioactive Moldable Bone Graft Matrix | Collagen Matrix, Inc. | MQV | Class II | 2024-03-12 |
| K233724 | 28mm/38D MDM X3 Insert for MDM Liner | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | LZO | Class II | 2024-03-11 |
| K233912 | ARIX Cannulated Screw System | Jeil Medical Corporation | HWC | Class II | 2024-03-11 |
| K233359 | DOMINION Expandable Corpectomy System | Astura Medical | MQP | Class II | 2024-03-08 |
| K233758 | Trivicta Hip Stem | Ortho Development Corp. | MEH | Class II | 2024-03-08 |
| K233198 | OSSIOfiber® Threaded Trimmable Fixation Nails | OSSIO , Ltd. | HWC | Class II | 2024-03-08 |
| K240407 | ICONIX All-Suture Anchor; ICONIX TT All-Suture Anchor; ICONIX with Needles All-Suture Anchor | Stryker Endoscopy | MBI | Class II | 2024-03-07 |
| K240458 | Synthetic Bone Putty | Ventris Medical | MQV | Class II | 2024-03-07 |
| K233075 | BioGend Interbody Fusion System 001 Cage | Biogend Therapeutics Co., Ltd. | MAX | Class II | 2024-03-06 |
| K240459 | Cerament Bone Void Filler | Bonesupport AB | MQV | Class II | 2024-03-05 |
| K240090 | Argo Knotless GENESYS Anchor | Conmed Corporation | MAI | Class II | 2024-03-05 |
| K240404 | NovaBone Putty - Bioactive Synthetic Bone Graft (NB6600, NB6610, NB6615) | Novabone Products, LLC | MQV | Class II | 2024-03-05 |
| K240453 | ReBOSSIS | Orthorebirth Co., Ltd. | MQV | Class II | 2024-03-04 |
| K233360 | Curiteva Thoracolumbar Plate System | Curiteva, Inc. | KWQ | Class II | 2024-02-29 |
| K240268 | Accu-Joint Hemi Implant | Accufix Surgical, Inc. | KWD | Class II | 2024-02-29 |
| K232842 | Balloon Inflation System | Ningbo Hicren Biotechnology Co., Ltd. | NDN | Class II | 2024-02-29 |
| K233972 | Camber Sacroiliac (SI) Fixation System | Camber Spine Technologies | OUR | Class II | 2024-02-27 |
| K232607 | 4CIS SARA SPINE SYSTEM, 4CIS VERTU SPINE SYSTEM, 4CIS WILL PEDICLE SCREW SYSTEM, aBle SPINAL FIXATION SYSTEM, aBle Xt SPINAL FIXATION SYSTEM | Solco Biomedical Copany India Private Limited | NKB | Class II | 2024-02-27 |
| K232628 | VADER® Pedicle System | Icotec AG | NKB | Class II | 2024-02-26 |
| K233675 | FMS VUE Fluid Management and Tissue Debridement System | DePuy Mitek, Inc. | HRX | Class II | 2024-02-26 |
| K240212 | COGNiTiON Staple System | Ortho Solutions UK , Ltd. | JDR | Class II | 2024-02-23 |
| K240201 | PathLoc SI Joint Fusion System | L&K BIOMED Co., Ltd. | OUR | Class II | 2024-02-23 |
| K240213 | Iconix Knotless Anchor | Riverpoint Medical | MBI | Class II | 2024-02-23 |
| K233640 | Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS Interbody System; Transcend SPS Interbody System;Transcend NanoTec SPS Interbody System | Alphatec Spine, Inc. | KWQ | Class II | 2024-02-22 |
| K240173 | Treace Medical Systems (TMC) Plating System | Treace Medical Concepts, Inc. | HRS | Class II | 2024-02-22 |
| K232265 | BLUEPRINT Patient Specific Instrumentation | Tornier S.A.S. | PHX | Class II | 2024-02-21 |
| K240194 | ProCinch, QuadCinch | Riverpoint Medical | MBI | Class II | 2024-02-21 |
| K233150 | NET BRAND Osteosynthesis Nailing System | Narang Medical , Ltd. | JDS | Class II | 2024-02-20 |
| K231657 | AGILON® XO Shoulder Replacement System | Implantcast GmbH | KWT | Class II | 2024-02-16 |
| K231453 | SnapHammer Hammertoe Correction System | Nvision Biomedical Technologies, Inc. | HWC | Class II | 2024-02-16 |
| K234028 | COPAL® exchange G hip spacer; COPAL® G+V | Heraeus Medical GmbH | KWL | Class II | 2024-02-15 |
| K231522 | EMPHASYS Dual Mobility System | Depuy Ireland UC | LPH | Class II | 2024-02-15 |
| K234048 | M.U.S.T. Pedicle Screw System - Extension | Medacta International S.A. | NKB | Class II | 2024-02-13 |
| K231134 | VerteLoc Spinal System | Signature Orthopaedics Pty, Ltd. | MQP | Class II | 2024-02-13 |
| K233260 | Univers Revers CA Head and Adapter | Arthrex, Inc. | HSD | Class II | 2024-02-12 |
| K233134 | I.T.S. INS Proximal Femur Nail | I.T.S. GmbH | HSB | Class II | 2024-02-12 |
| K240066 | Fine Osteotomy | Bodycad Laboratories, Inc. | PBF | Class II | 2024-02-09 |
| K240084 | V-STRUT® Vertebral Implant | Hyprevention | NDN | Class II | 2024-02-09 |
| K233476 | Z1 Hip System | Orchard Medical Development | LZO | Class II | 2024-02-08 |
| K233115 | Hawkeye Control Unit with Eyas Endoscope | E Surgical, LLC | HRX | Class II | 2024-02-06 |
| K233960 | INNOVERSE Spinal System | Innosys Co., Ltd. | NKB | Class II | 2024-02-06 |
| K233593 | MAGEC Spinal Bracing and Distraction System | Nuvasive Specialized Orthopedics, Incorporated | PGN | Class II | 2024-02-06 |
| K234013 | Mg OSTEOINJECT; Mg OSTEOREVIVE; Mg OSTEOCRETE | Bone Solutions, Inc. | MQV | Class II | 2024-02-05 |
| K234075 | Flow-Nail | Flow-Fx, LLC | HSB | Class II | 2024-02-05 |
| K233531 | OIC FLEX-FIX System | Orthopaedic Implant Company | HTN | Class II | 2024-02-02 |
| K232986 | VariTrax Sternal CircumFixation System | Circumfix Solutions, Inc. | JDQ | Class II | 2024-01-30 |
| K232432 | E3D-A Interbody System | Evolution Spine | OVD | Class II | 2024-01-30 |
| K231343 | Redemption Duo Hindfoot Nail System | Vilex, LLC | HSB | Class II | 2024-01-30 |
| K233508 | iFuse Bedrock Granite® Implant System | SI-BONE, Inc. | OUR | Class II | 2024-01-26 |
| K231715 | MONDRIAN Anterior Lumbar Plate System | Ctl Medical Corporation | KWQ | Class II | 2024-01-26 |
| K234116 | Trigon Trigon HA Stand-Alone Wedge Fixation System | Nvision Biomedical Technologies | PLF | Class II | 2024-01-26 |
| K233735 | ADIRA Lateral Plate System | Globus Medical, Inc. | KWQ | Class II | 2024-01-25 |
| K233893 | AlphaVent Knotless SP PEEK Anchor | Stryker Endoscopy | MBI | Class II | 2024-01-25 |
| K234087 | restor3d TIDAL Lumbar Interbody Fusion System | Restor3D | MAX | Class II | 2024-01-22 |
| K233105 | RESPONSE Rib and Pelvic System | OrthoPediatrics Corp. | MDI | Class II | 2024-01-20 |
| K231873 | DePuy SUMMIT Porocoat Hip Prosthesis MR Conditional, DePuy SUMMIT DuoFix Hip Prosthesis MR Conditional, DePuy SUMMIT Cemented Hip Prosthesis MR Conditional, DePuy SUMMIT FX Cemented Hip Prosthesis MR Conditional, DePuy SUMMIT Basic Press-Fit Hip Prosthesis MR Conditional | Depuy Ireland UC | MEH | Class II | 2024-01-19 |
| K230817 | TORPEDO Implant System® | Deltacor GmbH | OUR | Class II | 2024-01-19 |
| K232347 | MagnetOs Granules | Kuros Biosciences B.V | MQV | Class II | 2024-01-19 |
| K233436 | IlluminOss Photodynamic Bone Stabilization System | Illuminoss Medical, Inc. | QAD | Class II | 2024-01-19 |
| K231213 | HKT Anatomical Locking Trauma System | Hankil Tech Medical Co., Ltd. | HRS | Class II | 2024-01-19 |
| K234040 | TriMed Threaded Intramedullary Nail System | TriMed, Inc. | HWC | Class II | 2024-01-18 |
| K233507 | EVOLUTION® Tibial Cones | Microport Orthopedics, Inc. | MBH | Class II | 2024-01-18 |
| K233744 | Curiteva Porous PEEK Lumbar Interbody Fusion System | Curiteva, Inc. | MAX | Class II | 2024-01-18 |
| K231860 | TDM Screw System | Tdm Co., Ltd. | HWC | Class II | 2024-01-18 |
| K234011 | AMF TT Cones | Lima Corporate S.P.A. | JWH | Class II | 2024-01-18 |
| K234051 | Minuteman G5 MIS Fusion Plate; Minuteman G1(Posterior Fusion Plate /HA Posterior Fusion Plate); HA Minuteman G3-R MIS Fusion Plate; Minuteman G3/HA Minuteman G3 | Spinal Simplicity, LLC | PEK | Class II | 2024-01-18 |
| K234031 | Medline UNITE Ancillary Foot Recon Plating System | Medline Industires, LP | HRS | Class II | 2024-01-18 |
| K233730 | Footprint Mini PK, 3.5mm Suture Anchor | Smith & Nephew | MBI | Class II | 2024-01-17 |
| K231684 | Quick - Radius Disposable Set | GM Dos Reis Industria e Comercio Ltda. | HRS | Class II | 2024-01-12 |
| K233694 | Meridian Interbody System; WaveForm A Interbody System | SeaSpine Orthopedics Corporation | MAX | Class II | 2024-01-12 |
| K232990 | ATOMIC Nitinol Fixation System | Rmr Ortho, LLC | JDR | Class II | 2024-01-12 |
17,115 clearances in the Orthopedic panel. Data: openFDA.