Review Panel
Orthopedic FDA 510(k) Clearances & Devices
- Cleared Devices
- 17,115
- Product Codes (page)
- 36
- Latest Decision
- 2023-01-10
Clearances · page 18 of 172
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K211047 | CoCr Head | Zimmer GmbH | LPH | Class II | 2023-01-10 |
| K222799 | Haymaker® Screw System | Orthocircle Spine D.B.A. OC Medical Devices | HWC | Class II | 2023-01-10 |
| K211163 | Bone Cement Genta, Bone Cement HV, Bone Cement LV | Tecres S.P.A. | LOD | Class II | 2023-01-09 |
| K222789 | VADER® Pedicle System, G21 Cement | Icotec AG | PML | Class II | 2023-01-09 |
| K223412 | LumiVy Lumbar IBF System | Vy Spine, LLC | MAX | Class II | 2023-01-06 |
| K222296 | ARTICUL/EZE Ceramic Heads | Depuy Ireland UC | LZO | Class II | 2023-01-06 |
| K221149 | U-Motion II Acetabular System-Extension line | United Orthopedic Corporation | LZO | Class II | 2023-01-05 |
| K221181 | Treace Medical Concepts (TMC) Plating System | Treace Medical Concepts, Inc. | HRS | Class II | 2023-01-05 |
| K223650 | REMEDY Stemmed Knee Spacer | Osteoremedies, LLC | JWH | Class II | 2023-01-05 |
| K221266 | Cervical Spine Truss System (CSTS) Interbody Fusion Device | 4Web Medical, Inc. | ODP | Class II | 2023-01-05 |
| K223671 | CONDUIT LLIF Straight Inserters | Enztec Limited | MAX | Class II | 2023-01-05 |
| K220847 | AETOS Shoulder System | Smith & Nephew, Inc. | KWS | Class II | 2023-01-03 |
| K221333 | Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR Conditional | Acumed, LLC | HWC | Class II | 2022-12-29 |
| K223654 | Medussa-PL Cage | Medyssey USA, Inc. | MAX | Class II | 2022-12-28 |
| K222760 | StageOne Select Hip Cement Spacer Molds | Biomet, Inc. | MBB | Class II | 2022-12-28 |
| K221048 | Episealer Patellofemoral System | Episurf Medical, Inc. | KRR | Class II | 2022-12-23 |
| K221193 | OSSIOfiber Compression Screw, OSSIOfiber Compression Screw, 6.5mm | OSSIO , Ltd. | HWC | Class II | 2022-12-23 |
| K223565 | LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation System. | L&K BIOMED Co., Ltd. | NKB | Class II | 2022-12-23 |
| K223273 | ASTRA Spine System | Spinecraft, LLC | NKB | Class II | 2022-12-22 |
| K223105 | Tesera-K SC System | Kyocera Medical Technologies, Inc. | OVE | Class II | 2022-12-22 |
| K221396 | Arthrex FiberTak Suture Anchor | Arthrex, Inc. | MBI | Class II | 2022-12-22 |
| K222806 | Kodiak C Spinal Implant System | Met One Technologies, LLC | ODP | Class II | 2022-12-22 |
| K222774 | iFuse Bedrock Granite® Implant System | SI-BONE, Inc. | OUR | Class II | 2022-12-22 |
| K223244 | Pristine Arthroscopic Visualization System | Pristine Surgical | HRX | Class II | 2022-12-21 |
| K221221 | Advanced Intramedullary Nail System | Double Medical Technology, Inc. | HSB | Class II | 2022-12-21 |
| K222637 | TriMed Wrist Fixation System 3 | TriMed, Inc. | HRS | Class II | 2022-12-21 |
| K221735 | Mineral Collagen Composite Bioactive Moldable | Collagen Matrix, Inc. | MQV | Class II | 2022-12-20 |
| K221031 | Arthrex DualCompression Hindfoot Fusion Nail Implant System | Arthrex, Inc. | HSB | Class II | 2022-12-20 |
| K222405 | Smart SPACE Shoulder Planner and 3D Positioners | Lima Corporate S.P.A. | QHE | Class II | 2022-12-20 |
| K221926 | Invictus® Bone Cement, Invictus Spinal Fixation System | Alphatec Spine, Inc. | PML | Class II | 2022-12-20 |
| K223140 | AEON-C Stand Alone System | Dio Medical, Inc. | OVE | Class II | 2022-12-20 |
| K223294 | SpineJack® Expansion Kit | Stryker Instruments | NDN | Class II | 2022-12-20 |
| K213653 | 4CIS BLACK MARLIN PLIF CAGE SYSTEM, 4CIS DOLPHIN TLIF CAGE SYSTEM | Solco Biomedical Company India Private Limited | MAX | Class II | 2022-12-19 |
| K213196 | MARVEL Growing Rods | Globus Medical, Inc. | PGM | Class II | 2022-12-19 |
| K223251 | Hexanium PLIF | Spinevision, S.A.S. | MAX | Class II | 2022-12-16 |
| K222820 | BRM TOOL Screws, BIOPLAN Subtalar Implant | Brm Extremities | HWC | Class II | 2022-12-16 |
| K213110 | AUXILOCK PEEK OPTIMA Screw-In Suture Anchor, AUXILOCK ROTADOR PEEK OPTIMA Screw-In Anchor | Auxein Medical Private Limited | MBI | Class II | 2022-12-16 |
| K223184 | Phantom Metatarsal Shortening System | Paragon 28, Inc. | HWC | Class II | 2022-12-16 |
| DEN220012 | Tornier Pyrocarbon Humeral Head | Tornier S.A.S. | QKW | Class II | 2022-12-16 |
| K223153 | Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface Technology | Medtronic Sofamor Danek USA, Inc. | MAX | Class II | 2022-12-16 |
| K221342 | REDEMPTION Beaming System | Vilex, LLC | HWC | Class II | 2022-12-13 |
| K220921 | Metal Bone Screw | Double Medical Technology, Inc. | HWC | Class II | 2022-12-12 |
| K223510 | Matrix HA Fusion Porous Cervical IBF System | Innovasis, Inc. | ODP | Class II | 2022-12-12 |
| K223190 | Hive Standalone Cervical System | NanoHive Medical, LLC | OVE | Class II | 2022-12-12 |
| K221182 | Southern Transforaminal Lumbar Interbody Fusion (TLIF) | Southern Medical (Pty) , Ltd. | MAX | Class II | 2022-12-08 |
| K223112 | MAVERICK Mini External Fixation System | Smith & Nephew, Inc. | JDW | Class II | 2022-12-08 |
| K220843 | OAKTREE Anterior Lumbar Plate and Screw System | Oak Tree Engineering, LLC | KWQ | Class II | 2022-12-07 |
| K221021 | Femoral Trochanteric Nail System Neonail | Neoortho Produtos Ortopédicos S/A | HSB | Class II | 2022-12-06 |
| K222614 | Zavation Spinal System | Zavation Medical Products, LLC | NKB | Class II | 2022-12-05 |
| K221806 | TruLift Lateral Expandable Spacer System & Lateral Plate System | Life Spine, Inc. | MAX | Class II | 2022-12-05 |
| K223211 | INHANCETM Shoulder System Humeral Stems and Stemless | Depuy Ireland UC | PHX | Class II | 2022-12-02 |
| K222516 | Mercury® II Spinal System | Spinal Elements, Inc. | NKB | Class II | 2022-12-01 |
| K223226 | Trigon HA Stand-Alone Wedge Fixation System | Nvision Biomedical Technologies, Inc. | PLF | Class II | 2022-12-01 |
| K222363 | Aevumed PHANTOM-LP Suture Anchors | Aevumed, Inc. | MBI | Class II | 2022-11-28 |
| K223274 | Momentum® MIS Posterior Spinal Fixation System | Ulrich Medical USA | NKB | Class II | 2022-11-28 |
| K222967 | Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Screws, Avanti Orthopaedics 3.2mm and 4.0mm Cannulated Screws | Avanti Orthopaedics, Inc. | HWC | Class II | 2022-11-23 |
| K213459 | Glenoid Reconstruction System | Medacta International S.A. | PHX | Class II | 2022-11-23 |
| K221412 | ARIX Rib System | Jeil Medical Corporation | HRS | Class II | 2022-11-22 |
| K222009 | aprevo® anterior lumbar interbody fusion device with interfixation | Carlsmed, Inc. | OVD | Class II | 2022-11-22 |
| K222964 | BioPoly Lesser Toe Hemiarthroplasty Implant | BioPoly, LLC | KWD | Class II | 2022-11-22 |
| K222645 | Treace Medical Concepts (TMC) Implant Fixation System | Treace Medical Concepts | JDR | Class II | 2022-11-21 |
| K222390 | Flex-Thread Ulna Intramedullary Nail System | Flower Orthopedics Corporation Dba Conventus Flower | HSB | Class II | 2022-11-21 |
| K213018 | Auxilock GFS Mini, GFS II Large, and GFS Ultimate | Auxein Medical Private Limited | MBI | Class II | 2022-11-18 |
| K222816 | Opulent TiNbN Coated Knee | Meril Healthcare Pvt. , Ltd. | JWH | Class II | 2022-11-18 |
| K222903 | Tailored-H Cervical Stand Alone System | Bespoke Technologies, LLC | OVE | Class II | 2022-11-18 |
| K222493 | CODA Anterior Cervical Plate System | Pioneer Surgical Technology, Inc. | KWQ | Class II | 2022-11-18 |
| K220658 | COSY Cervicothoracic Occipital Rod-Screw System | Signus Medizintechnik GmbH | NKG | Class II | 2022-11-18 |
| K222455 | Calibrate LTX Interbody System | Alphatec Spine, Inc. | MAX | Class II | 2022-11-18 |
| K221479 | Persona Personalized Knee System | Zimmer, Inc. | JWH | Class II | 2022-11-17 |
| K223227 | MAVEN Patient-Specific Instrumentation | Paragon 28, Inc. | HSN | Class II | 2022-11-17 |
| K222973 | IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System, IdentiTi NanoTec Cervical Interbody System, Transcend Cervical PEEK Interbody System, Transcend NanoTec Cervical Interbody System, IdentiTi Cervical Standalone Interbody System, IdentiTi NanoTec Cervical Standalone Interbody Sytem | Alphatec Spine, Inc. | ODP | Class II | 2022-11-17 |
| K222628 | Life Spine ALIF Buttress Plate System | Life Spine, Inc. | KWQ | Class II | 2022-11-16 |
| K222309 | Gamma4 System | Stryker GmbH | HSB | Class II | 2022-11-15 |
| K222564 | Treace Medical Concepts (TMC) Hammertoe Fixation System | Treace Medical Concepts, Inc. | HWC | Class II | 2022-11-15 |
| K221558 | ALPHALOK Plating System | Vilex, LLC | HRS | Class II | 2022-11-15 |
| K212612 | Omnia Medical TiBrid-SC | Omnia Medical, LLC | OVE | Class II | 2022-11-15 |
| K212700 | Dyflex-II | Taeyeon Medical Co., Ltd. | NKB | Class II | 2022-11-15 |
| K222490 | HBL Blade Assembly | Hand Biomechanics Lab, Inc. | HRX | Class II | 2022-11-14 |
| K210980 | Smith & Nephew Intramedullary Nail Systems | Smith & Nephew, Inc. | HSB | Class II | 2022-11-14 |
| K221578 | Hexanium ACIF | Spinevision, S.A.S. | OVE | Class II | 2022-11-14 |
| K222317 | Catalyst EA Convertible Stemmed Shoulder | Catalyst Orthoscience, Inc. | KWS | Class II | 2022-11-10 |
| K220334 | MONET Anterior Cervical Plate System | Ctl Medical Corporation | KWQ | Class II | 2022-11-09 |
| K222732 | WaveForm A Interbody System | SeaSpine Orthopedics Corporation | MAX | Class II | 2022-11-07 |
| K222936 | Humeris® 135 Shoulder System | Fx Shoulder USA, Inc. | PHX | Class II | 2022-11-07 |
| K223062 | World Total Knee System | Signature Orthopaedics Pty, Ltd. | JWH | Class II | 2022-11-04 |
| K213108 | Humerus & Ulna System | Auxein Medical Private Limited | HRS | Class II | 2022-11-04 |
| K220833 | Citregen Tendon Interference Screw, Citrelock, Citrefix, Citrespline ACL, and Citrelock ACL | Acuitive Technologies, Inc. | MAI | Class II | 2022-11-04 |
| K221610 | Nextra CH Cannulated Hammertoe System | Nextremity Solutions, Inc. | HWC | Class II | 2022-11-04 |
| K221675 | United U2 femoral head, 22mm delta ceramic head | United Orthopedic Corporation | LPH | Class II | 2022-11-04 |
| K221162 | UniVy OsteoVy Cervical IBF System | Vy Spine, LLC | ODP | Class II | 2022-11-04 |
| K222107 | Black Diamond POCT Spinal System | Osseus Fusion Systems | NKG | Class II | 2022-11-03 |
| K221719 | ABTross ALIF Expandable Cage System | Aegis Spine, Inc. | MAX | Class II | 2022-11-03 |
| K222031 | Spinal Inner Fixation System | Changzhou Geasure Medical Apparatus and Instruments Co., Ltd. | NKB | Class II | 2022-10-28 |
| K222653 | JOURNEY II UK and ENGAGE Cementless Partial Knee System | Smith+Nephew, Inc. | NJD | Class II | 2022-10-28 |
| K221489 | Artemis Proximal Femoral Nail System | Glw, Inc. | HSB | Class II | 2022-10-27 |
| K222282 | HEMC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System | Hospital Equipment Manufacturing Company | HRS | Class II | 2022-10-27 |
| K222505 | CurvaFix IM System | Curvafix, Inc. | HWC | Class II | 2022-10-27 |
| K223065 | Adcura® Sagittae® Lateral Lumbar Interbody Fusion Devices | Adcura, Inc. | MAX | Class II | 2022-10-26 |
| K220132 | FIREFLY® Cervical Navigation Guide | Mighty Oak Medical, Inc. | QSD | Class II | 2022-10-26 |
| K222807 | TEMA Elbow system - Line extension | Lima Corporate S.P.A. | JDB | Class II | 2022-10-26 |
17,115 clearances in the Orthopedic panel. Data: openFDA.