Review Panel
Orthopedic FDA 510(k) Clearances & Devices
- Cleared Devices
- 17,115
- Product Codes (page)
- 36
- Latest Decision
- 2022-05-13
Clearances · page 21 of 172
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K221115 | Flow-Nail | Flow-Fx, LLC | HSB | Class II | 2022-05-13 |
| K220723 | Hand Trauma Screw System | Skeletal Dynamics, Inc. | HWC | Class II | 2022-05-12 |
| K221059 | Identity Imprint Knee Replacement System (including Identity Imprint Posterior Stabilized (PS) KRS and Identity Imprint Cruciate Retaining (CR) KRS) | Conformis, Inc. | JWH | Class II | 2022-05-10 |
| K220711 | SeaSpine Meridian System, SeaSpine Meridian Anterior Plate System | SeaSpine Orthopedics Corporation | MAX | Class II | 2022-05-10 |
| K213935 | PISCES-SA Standalone ALIF Interbody System | Osseus Fusion Systems | OVD | Class II | 2022-05-06 |
| K220705 | MyKnee R Pin Positioners | Medacta International S.A. | JWH | Class II | 2022-05-04 |
| K213420 | WaveForm L System, WaveForm TO System, WaveForm TA System | SeaSpine Orthopedics Corporation | MAX | Class II | 2022-05-04 |
| K220628 | LINK Endo-Model EVO Knee System | Waldemar Link GmbH & Co. KG | KRO | Class II | 2022-05-03 |
| K213837 | Arthrx Fracture Plates | Arthrex, Inc. | HRS | Class II | 2022-05-02 |
| K212348 | ALPHALOK Plating System | Vilex, LLC | HRS | Class II | 2022-05-02 |
| K220341 | ARx Modular Spinal System | Life Spine, Inc. | NKB | Class II | 2022-05-02 |
| K220244 | DVR® Crosslock Wrist Spanning Plate (131849181) | Pioneer Surgical Technology, Inc D.B.A Resolve Surgical Tech | HRS | Class II | 2022-04-28 |
| K212477 | EARP Interbody System | Nvision Biomedical Technologies, Inc. | MAX | Class II | 2022-04-28 |
| K212512 | G7® Vivacit-E® Freedom® Constrained Liner | Zimmer, Inc. | PBI | Class II | 2022-04-28 |
| K220892 | ExsoMed INnate NanoTM Lag Screw System | Exsomed Corp. | HWC | Class II | 2022-04-27 |
| K220896 | Legion Inserts with JRNY Lock | Smith & Nephew, Inc. | JWH | Class II | 2022-04-26 |
| K220570 | M.U.S.T. MINI Posterior Cervical Screws System Extension | Medacta International S.A. | NKG | Class II | 2022-04-26 |
| K212608 | RibFix Blu Thoracic Fixation System | Biomet Microfixation | HRS | Class II | 2022-04-22 |
| K212737 | INHANCE Reverse Shoulder System | Depuy Ireland UC | PHX | Class II | 2022-04-21 |
| K211837 | Altus Spine Interbody Standalone Fusion System | Altus Partners, LLC | OVD | Class II | 2022-04-19 |
| K220810 | Infinity OCT System and PASS OCT Spinal System | Medicrea International | NKG | Class II | 2022-04-19 |
| K220131 | KYPHON VuE Bone Cement | Tecres S.P.A. | NDN | Class II | 2022-04-18 |
| K220797 | FootHold System | Crossroads Extremity Systems, LLC | MBI | Class II | 2022-04-15 |
| K213959 | MagnetOs Flex Matrix | Kuros Biosciences B.V | MQV | Class II | 2022-04-14 |
| K210146 | Cannulated Compression Device System | Orthopedic Designs North America, Inc. | HWC | Class II | 2022-04-13 |
| K220405 | Amis K Long | Medacta International S.A. | LZO | Class II | 2022-04-12 |
| K214010 | Anteralign Spinal System with Titan nanoLOCK Surface Technology | Medtronic Sofamor Danek USA | MAX | Class II | 2022-04-12 |
| K212811 | Ti3Z Lumbar Interbody System | Zavation Medical Products, LLC | MAX | Class II | 2022-04-12 |
| K213675 | MP Reconstruction System | Waldemar Link GmbH & Co. KG | LZO | Class II | 2022-04-11 |
| K212962 | TRELLIS SI Joint Fusion System | Orthofundamentals, LLC | OUR | Class II | 2022-04-11 |
| K220737 | World Knee Vit-E All-poly Tibial Inserts (CR, PS and UC), World Knee Vit-E Meniscal Inserts (CR, PS and UC) | Signature Orthopaedics Pty, Ltd. | JWH | Class II | 2022-04-11 |
| K213958 | Bioabsorbable Anchor | Embody, Inc. | MAI | Class II | 2022-04-08 |
| K220724 | CD Horizon Spinal System and PASS LP Spinal System | Medicrea International | NKB | Class II | 2022-04-08 |
| K220809 | Drive Rail System | OrthoPediatrics Corp. | KTT | Class II | 2022-04-08 |
| K212069 | Corin MetaFix Hip Stem | Corin U.S.A. Limited | LZO | Class II | 2022-04-07 |
| K212601 | DRPx Locking Distal Radius Plate System | Orthopaedic Implant Company | HRS | Class II | 2022-04-05 |
| K212126 | MediExpand Cervical Expandable VBR System | Cmf Medicon Surgical, Inc. | PLR | Class II | 2022-04-04 |
| K214006 | Invictus® Spinal Fixation System | Alphatec Spine, Inc. | NKB | Class II | 2022-04-04 |
| K213118 | Dakota ALIF System | Precision Spine, Inc. | OVD | Class II | 2022-04-01 |
| K213793 | EMPOWR Revision Knee | Encore Medical L.P. | JWH | Class II | 2022-04-01 |
| K220260 | Hercules Syndesmosis Implant System | In2bones USA, LLC | HTN | Class II | 2022-03-31 |
| K220025 | ARx® Spinal System | Life Spine, Inc. | NKB | Class II | 2022-03-31 |
| K214047 | EL CAPITAN Anterior Lumbar Interbody Fusion System | Astura Medical | OVD | Class II | 2022-03-30 |
| K220182 | Aggeris-C | Clariance | KWQ | Class II | 2022-03-30 |
| K202266 | Reliance Cervical IBF System | Reliance Medical Systems, LLC | ODP | Class II | 2022-03-29 |
| K213415 | OSSIOfiber Suture Anchor | OSSIO , Ltd. | MAI | Class II | 2022-03-28 |
| K213355 | Toro-L Interbody Fusion System | Integrity Implants, Inc. | MAX | Class II | 2022-03-25 |
| K213820 | BALTEUM - ONE Lumbar Plate System | Huvexel Co. , Ltd. | KWQ | Class II | 2022-03-25 |
| K220655 | X-Pac Expandable Lumbar Cage System | Expanding Innovations, Inc. | MAX | Class II | 2022-03-24 |
| K220453 | FlareHawk Interbody Fusion System | Integrity Implants, Inc. | MAX | Class II | 2022-03-24 |
| K220492 | COPAL exchange G hip spacer | Heraeus Medical GmbH | KWY | Class II | 2022-03-23 |
| K220511 | Medline UNITE IM Fibula Implant | Medline Industries, LP | HWC | Class II | 2022-03-22 |
| K220181 | StealthFix Intraosseous Fixation System | Nextremity Solutions, Inc. | JDR | Class II | 2022-03-22 |
| K220199 | AFFINITY Proximal Tibia System | Techfit Digital Surgery, Inc. | HRS | Class II | 2022-03-21 |
| K213563 | DePuy Synthes Radial Head Replacement System | DePuy Synthes | KWI | Class II | 2022-03-18 |
| K212498 | Stable-L Standalone Lumbar Interbody System | Nexus Spine, LLC | OVD | Class II | 2022-03-18 |
| K220275 | EMERGE Anterior Cervical Plate System | Evolution Spine | KWQ | Class II | 2022-03-18 |
| K220324 | AccuFit Lateral 2-Hole Plate | Precision Spine, Inc. | KWQ | Class II | 2022-03-16 |
| K213980 | Peridot Spinal Interbody System | Gbs Commonwealth Co., Ltd. | ODP | Class II | 2022-03-15 |
| K220049 | Optimotion Implants Porous Metal-Backed Patella | Optimotion Implants, LLC | MBH | Class II | 2022-03-14 |
| K211324 | 2.4mm Distal Radius System | Auxein Medical Private Limited | HRS | Class II | 2022-03-14 |
| K201229 | Intai Anatomic Locking Plate and Screw System | Intai Technology Corporation | HRS | Class II | 2022-03-11 |
| K213005 | Apollo Ankle Fracture Plating System | Glw Medical, Inc. | HRS | Class II | 2022-03-11 |
| K213712 | Pectus Support Bar System | Biomet Microfixation | HRS | Class II | 2022-03-11 |
| K213827 | TITAN Total Shoulder System (TSS), TITAN Reverse Shoulder System (RSS), TITAN Humeral Resurfacing Arthroplasty System (HRA), Modular Radial Head System (MRH), Katalyst Bipolar Radial Head System (Katalyst) | Smith & Nephew, Inc. | KWS | Class II | 2022-03-11 |
| K213615 | Shoulder Innovations Total Shoulder System | Shoulder Innovations, Inc. | PKC | Class II | 2022-03-11 |
| K211880 | Minuteman G5 MIS Fusion Plate | Spinal Simplicity, LLC | PEK | Class II | 2022-03-11 |
| K212755 | SIGNUS SACRONAIL® Transsacral Stabilization System | Signus Medizintechnik GmbH | HWC | Class II | 2022-03-10 |
| K213441 | PathLoc Lumbar Interbody Fusion Cage System | L&K BIOMED Co., Ltd. | MAX | Class II | 2022-03-09 |
| K220096 | Genesys Spine 3DP Lumbar Interbody System | Genesys Spine | MAX | Class II | 2022-03-09 |
| K220376 | Acetabular Dome Hole Plug | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | LPH | Class II | 2022-03-09 |
| K220374 | EXPEDIUM VERSE® Fenestrated Screw System (Sterile Fenestrated Screws) | Medos International SARL | NKB | Class II | 2022-03-08 |
| K212356 | Exactech® Equinoxe® Laser Cage Glenoid | Exactech, Inc. | KWS | Class II | 2022-03-04 |
| K211843 | PolyLock Plating System | Fusion Orthopedics | HRS | Class II | 2022-03-04 |
| K220379 | IMPEACE and IMPEACE-Uni Anterior Cervical Plate System | Medynus, Inc. | KWQ | Class II | 2022-03-03 |
| K213567 | Medline UNITE Calcaneal Fracture Plating System | Medline Industries, LP | HRS | Class II | 2022-03-02 |
| K213590 | Blue Topaz Sacroiliac Screw System | Osseus Fusion Systems, LLC | OUR | Class II | 2022-03-01 |
| K212187 | Restoration® Modular Hip System | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | LPH | Class II | 2022-03-01 |
| K213750 | VyLink Spinal Screw System | Vy Spine, LLC | NKB | Class II | 2022-02-28 |
| K212800 | PRIMA Humeral System and SMR Glenosphere Ø42 | Lima Corporate S.P.A. | PHX | Class II | 2022-02-25 |
| K211320 | CAPRI Corpectomy Cage System | K2m, Inc. | PLR | Class II | 2022-02-24 |
| K212378 | Arsenal Ankle Plating System | Trilliant Surgical | HRS | Class II | 2022-02-23 |
| K220197 | Trigon HA Wedge Fixation System | Nvision Biomedical Technologies, Inc. | PLF | Class II | 2022-02-23 |
| K213654 | NuVasive Reline Cervical System | Nu Vasive, Incorporated | NKG | Class II | 2022-02-23 |
| K212627 | True Tulip, True M.I.S. | Innovative Surgical Designs, Inc. | NKB | Class II | 2022-02-18 |
| K201510 | Traufix osteosynthesis, osteotomy, and arthrodesis devices | Fixier S.A. DE C.V. | HRS | Class II | 2022-02-18 |
| K213982 | Pacific Instruments Orthopedic Fixation Pins and Wires / Kirschner / Guide Wires | Pacific Instruments | HTY | Class II | 2022-02-17 |
| K220136 | Treace Medical Concepts (TMC) Plating System | Treace Medical Concepts, Inc. | HRS | Class II | 2022-02-16 |
| K220147 | Aspiron S ACP System | U&I Corporation | KWQ | Class II | 2022-02-16 |
| K212930 | LumiVy Lumbar IBF System | Vy Spine, LLC | MAX | Class II | 2022-02-16 |
| K211712 | 3° Anterior Cervical Plating System, Reliant Anterior Cervical Plating System, Unity Lumbosacral Fixation System, Hallmark Anterior Plate System, NewBridge Laminoplasty Fixation System, CETRA Anterior Cervical Plate System | Orthofix US, LLC | KWQ | Class II | 2022-02-11 |
| K212545 | FlexitSystem Knee osteotomy system | Neosteo | HRS | Class II | 2022-02-11 |
| K213874 | MAVERICK External Fixation System | Smith & Nephew, Inc. | JDW | Class II | 2022-02-11 |
| K213328 | Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing System | Stryker GmbH | HSB | Class II | 2022-02-11 |
| K203811 | GPC Intraheal Intramedullary Nailing System | Gpc Medical Limited | HSB | Class II | 2022-02-10 |
| K212431 | Biomet Answer/Impact/Integral Distal Centralizer/Centering Sleeve | Biomet, Inc. | JDG | Class II | 2022-02-07 |
| K211417 | F3D-C2 Cervical Stand-Alone System | Corelink, LLC | OVE | Class II | 2022-02-04 |
| K212721 | Genex Bone Graft Substitute | Biocomposites, Ltd. | MQV | Class II | 2022-02-04 |
| K203335 | MectaScrew Extension | Medacta International S.A. | HWC | Class II | 2022-02-03 |
| K213812 | PALACOS MV pro | Heraeus Medical GmbH | LOD | Class II | 2022-02-02 |
17,115 clearances in the Orthopedic panel. Data: openFDA.