Review Panel
Orthopedic FDA 510(k) Clearances & Devices
- Cleared Devices
- 17,115
- Product Codes (page)
- 34
- Latest Decision
- 2022-02-01
Clearances · page 22 of 172
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K213701 | Exeter® X3® RimFit® Cup | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | JDI | Class II | 2022-02-01 |
| K211628 | MIS Precision Chevron Bunion System | Relja Innovations, LLC | HWC | Class II | 2022-01-31 |
| K213493 | Fortilink with TiPlus Technology | Paradigm Spine | ODP | Class II | 2022-01-27 |
| K213489 | Wishbone Medical Plate and Screw System: 3.0mm Screws and 7-Hole Straight Fibula Plate | Wishbone Medical, Inc. | HRS | Class II | 2022-01-27 |
| K213591 | ANTHEM® Fracture System | Globus Medical, Inc. | HRS | Class II | 2022-01-26 |
| K202914 | SternaFuse Fixation System | Fusion Innovations, LLC | HRS | Class II | 2022-01-26 |
| K212991 | Osteorevive | Bone Solutions, Inc. | MQV | Class II | 2022-01-21 |
| K213470 | PERLA® TL Posterior Osteosynthesis System | Spineart | NKB | Class II | 2022-01-21 |
| K212594 | OSSIOfiber® Staple | OSSIO , Ltd. | MNU | Class II | 2022-01-21 |
| K213673 | b-ONE MOBIO Total Knee System | B-One Ortho, Corp. | JWH | Class II | 2022-01-21 |
| K212941 | Porous Patella | Encore Medical, L.P. Dba Djo Surgical | MBH | Class II | 2022-01-20 |
| K212581 | VariAx 2 Distal Radius System, VariAx 2 Distal Ulna System | Stryker GmbH | HRS | Class II | 2022-01-19 |
| K211613 | Stern Fix Sternal Stabilization System | Neos Surgery S.L | JDQ | Class II | 2022-01-19 |
| K211330 | R3 Large Head Liners | Smith & Nephew, Inc. | LPH | Class II | 2022-01-19 |
| K212683 | GLOBAL ICON Stemless Shoulder System | Depuy(Ireland) | PKC | Class II | 2022-01-19 |
| K213572 | JuniOrtho Plating System | Orthofix Srl | HWC | Class II | 2022-01-18 |
| K213781 | ATTUNE® Porous Fixed Bearing Tibial Base with AFFIXIUM 3DP | Depuy Ireland UC | MBH | Class II | 2022-01-18 |
| K203773 | BRM TOOL Screws | Brm Extremities Srl | HWC | Class II | 2022-01-14 |
| K213895 | Distal Humerus Plating System | Skeletal Dynamics, Inc. | HRS | Class II | 2022-01-13 |
| K212569 | Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner | Materialise NV | QHE | Class II | 2022-01-12 |
| K213199 | Asnis® III Cannulated Screw System and Asnis® PRO Cannulated Screw System | Stryker GmbH | HWC | Class II | 2022-01-11 |
| K213111 | MagnetOs granules | Kuros Biosciences B.V | MQV | Class II | 2022-01-10 |
| K212358 | Romero Cervical Cage | Spineup, Inc. | OVE | Class II | 2022-01-10 |
| K212990 | Acumed Ankle Syndesmosis Repair System | Acumed, LLC | HTN | Class II | 2022-01-07 |
| K213901 | Cyclops Anterior Cervical Plate System | Degen Medical | KWQ | Class II | 2022-01-07 |
| K212841 | Pectus Blu Support Bar System | Biomet Micofixation | HRS | Class II | 2022-01-07 |
| K210198 | GPC 2.4mm Variable Angle Locking Twon Column Volar Distal Radius Plates, 6 head Holes, GPC 2.4mm Variable Angle Locking Two Column Volar Distal Radius Plates, 7 Head Holes, 2.4 mm Variable Angle Locking Two Column Volar Distal Radius Plate-Narrow, 6 Head Holes, Variable Angle Locking Screw 2.4 mm, Stardrive | Gpc Medical Limited | HRS | Class II | 2022-01-07 |
| K211742 | SignaSure Dual Mobility System | Signature Orthopaedics Pty, Ltd. | MEH | Class II | 2022-01-07 |
| K212980 | Tesera-k ALIF System | Kyocera Medical Technologies, Inc. | OVD | Class II | 2022-01-07 |
| K213839 | DePuy Corail AMT Hip Prosthesis | DePuy Orthopaedics, Inc. | LZO | Class II | 2022-01-06 |
| K213281 | PASS LP Spinal System, CD Horizon Spinal System | Medicrea International SA | NKB | Class II | 2022-01-05 |
| K213951 | FORZA XP Expandable Spacer System | Orthofix US, LLC | MAX | Class II | 2022-01-05 |
| K213817 | MPO Knee Instruments; MPO PROPHECY Knee Instruments | Microport Orthopedics, Inc. | MBH | Class II | 2022-01-05 |
| K213816 | MPO Hip Instruments | Microport Orthopedics, Inc. | JDI | Class II | 2022-01-05 |
| K213342 | PRO-DENSE LoVisc Bone Graft Substitute | Wrightmedicaltechnologyinc | MQV | Class II | 2022-01-05 |
| K211789 | restor3d Pin Implants | Restor3D | HTY | Class II | 2022-01-04 |
| K203595 | DynaFuse Fixation System | MedShape, Inc. | HWC | Class II | 2022-01-04 |
| K212547 | Quick-Start Screws | Innovate Orthopaedics Limited | HWC | Class II | 2021-12-30 |
| K203523 | Fixone hybrid knotless anchor | Aju Pharm Co., Ltd. | MAI | Class II | 2021-12-25 |
| K211770 | R3ACT Stabilization System | Paragon 28, Inc. | HWC | Class II | 2021-12-25 |
| K213219 | Vy Spine VyWasher Buttress System | Vy Spine, LLC | KWQ | Class II | 2021-12-23 |
| K203714 | NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System, NuVasive CoRoent XL Interfixated System, Brigade System, Brigade Lateral System, BASE Interfixated Titanium System, Coalesce Thoracolumbar Interbody Fusion System, NuVasive Cohere Thoracolumbar Interbody System, NuVasive Modulus XLIF Interbody System, NuVasive Modulus TLIF Interbody System, NuVasive Modulus ALIF System, NuVasive Attrax Putty | Nu Vasive, Incorporated | MAX | Class II | 2021-12-23 |
| K213596 | OSSIOfiber Compression Screw, 3.5mm | OSSIO , Ltd. | HWC | Class II | 2021-12-21 |
| K211086 | The Progen Trochanteric Nail System | Ortho Development Corporation | HSB | Class II | 2021-12-21 |
| K213129 | Restoration Modular 115mm Conical Distal Stem | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | LZO | Class II | 2021-12-21 |
| K212266 | FIX-C PEEK Anterior Cervical Interbody System | Jeil Medical Corporation | ODP | Class II | 2021-12-21 |
| K213301 | InCore Subtalar System | Nextremity Solutions, Inc. | HWC | Class II | 2021-12-21 |
| K213456 | Xenco Medical Multilevel CerviKit | Xenco Medical, LLC | KWQ | Class II | 2021-12-21 |
| K202568 | Mpact® 3D Metal Implants - DMLS Technology | Medacta International S.A. | LPH | Class II | 2021-12-20 |
| K212715 | Vy Spine ClariVy Cervical IBF System | Vy Spine, LLC | ODP | Class II | 2021-12-20 |
| K212872 | Avenger Radial Head System | In2bones USA, LLC | KWI | Class II | 2021-12-17 |
| K213644 | Arthrex Knotless Mini TightRopes | Arthrex, Inc. | HTN | Class II | 2021-12-17 |
| K213381 | Physica system | Lima Corporate S.P.A. | JWH | Class II | 2021-12-17 |
| K202803 | Activmotion S DTO | Newclip Technics | HRS | Class II | 2021-12-16 |
| K211471 | Balanced Knee System Uni | Ortho Development Corporation | HSX | Class II | 2021-12-16 |
| K212781 | Posterior Fusion Plate/HA Posterior Fusion Plate, Minuteman G3 MIS Fusion Plate, HA Minuteman G3 MIS Fusion Plate, HA Minuteman G3-R MIS Fusion Plate | Spinal Simplicity, LLC | PEK | Class II | 2021-12-15 |
| K213443 | Insignia Anterior Cervical Plate System | Alphatec Spine, Inc. | KWQ | Class II | 2021-12-15 |
| K212903 | SIMPACT Sacroiliac Joint Fixation System | Life Spine, Inc. | OUR | Class II | 2021-12-15 |
| K212904 | SeaSpine WaveForm C Interbody System | SeaSpine Orthopedics Corporation | OVE | Class II | 2021-12-14 |
| K213069 | CoLink NeoFuse Plating System | In2bones USA, LLC | HRS | Class II | 2021-12-13 |
| K212428 | Centerpiece Plate Fixation System | Medtronic Sofamor Danek | NQW | Class II | 2021-12-13 |
| K213460 | Invictus Spinal Fixation System | Alphatec Spine, Inc. | NKB | Class II | 2021-12-10 |
| K213394 | Vy Spine VySpan PCT System | Vy Spine, LLC | NKG | Class II | 2021-12-10 |
| K212435 | Comprehensive Humeral Fracture Positioning Sleeves | Biomet, Inc. | KWS | Class II | 2021-12-10 |
| K211612 | Medline UNITE REFLEX Dynamic Discs | Medline Industries, Inc. | HTN | Class II | 2021-12-10 |
| K210842 | VerSys Cemented Revision/Calcar | Zimmer, Inc. | JDI | Class II | 2021-12-10 |
| K213359 | SeaSpine WaveForm, C Interbody System | SeaSpine Orthopedics Corporation | OVE | Class II | 2021-12-09 |
| K212034 | LOSPA TKR System | Corentec Co., Ltd. | JWH | Class II | 2021-12-09 |
| K213530 | Nextra CH Cannulated Hammertoe System | Nextremity Solutions, Inc. | HWC | Class II | 2021-12-09 |
| K212075 | ShurFit Lumbar Interbody System | Precision Spine, Inc. | MAX | Class II | 2021-12-08 |
| K212524 | Anteralign Spinal System with Titan nanoLOCK Surface Technology | Medtronic Sofamor Danek USA, Inc. | MAX | Class II | 2021-12-08 |
| K212381 | VersaTap, VersaLat, DueLock, VersaTi, MiniTi | Ortho-Design (Pty), Ltd. | MBI | Class II | 2021-12-06 |
| K213115 | CHENA-C Spacer System | Kahtnu Surgical, Inc. | ODP | Class II | 2021-12-06 |
| K213580 | Adapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head length | Total Joint Othopedics, Inc. | LZO | Class II | 2021-12-03 |
| K213266 | Inspan ScrewLES Fusion System | Lespine Innovations, LLC | PEK | Class II | 2021-12-03 |
| K212050 | NGM WAVE PLIF Cage | NGMedical GmbH | MAX | Class II | 2021-12-01 |
| K202024 | ARROW Short Stem Humeral System | FH Industrie | PHX | Class II | 2021-11-30 |
| K212237 | 3D-Cut | 3D-Side S.A. | PBF | Class II | 2021-11-29 |
| K213214 | Xpert Wrist | Newclip Technics | HRS | Class II | 2021-11-24 |
| K211650 | The Radian MIS Bunion System | Nvision Biomedical Technologies, Inc. | HRS | Class II | 2021-11-24 |
| K212653 | Catalyft LS Expandable Interbody System | Medtronic Sofamor Danek USA, Inc. | MAX | Class II | 2021-11-19 |
| K210573 | Velofix SA Cervical Cage | U&I Corporation | OVE | Class II | 2021-11-19 |
| K213421 | Vector® Hammertoe Correction System | Nvision Biomedical Technologies, Inc. | HWC | Class II | 2021-11-19 |
| K212640 | Stratum® Ankle Fusion Plating System | Nextremity Solutions, Inc. | HRS | Class II | 2021-11-18 |
| K212992 | LINK® Embrace Shoulder System - Reverse Configuration | Waldemar Link GmbH & Co. KG | PHX | Class II | 2021-11-18 |
| K212487 | CoLink Vallux Plating System | In2bones USA, LLC | HRS | Class II | 2021-11-18 |
| K212415 | Arthrex Modular Glenoid System-Titanium Glenosphere | Arthrex, Inc. | PHX | Class II | 2021-11-17 |
| K212839 | Opulent TiNbN Coated Knee | Meril Healthcare Pvt. , Ltd. | JWH | Class II | 2021-11-16 |
| K212996 | Sterile PHALINX Hammertoe System | Wrightmedicaltechnologyinc | HWC | Class II | 2021-11-16 |
| K213071 | MOTOTM Partial Knee & MOTO PFJ Systems Extension | Medacta International S.A. | HSX | Class II | 2021-11-16 |
| K211845 | Deploy Expandable Interbody System | Southern Spine, LLC | MAX | Class II | 2021-11-16 |
| K211359 | Tornier Perform Patient-Matched Primary Reversed Glenoid and BLUEPRINT Patient Specific Instrumentation | Tornier, Inc. | PHX | Class II | 2021-11-12 |
| K213389 | Identity Imprint Cruciate Retaining (CR) Knee Replacement System and Identity Imprint Posterior Stabilized (PS) Knee Replacement System | Conformis, Inc. | JWH | Class II | 2021-11-10 |
| K211244 | VSP® Orthopedics System | 3D Systems | PBF | Class II | 2021-11-10 |
| K202326 | BESPA Charcot System | Bespa Global, LLC | HWC | Class II | 2021-11-09 |
| K212895 | Paragon 28 External Ring Fixation System | Paragon 28, Inc. | KTT | Class II | 2021-11-08 |
| K212853 | Cervical Stand-Alone System | Eminent Spine, LLC | OVE | Class II | 2021-11-05 |
| K212044 | TrueLok Evo | Orthofix Srl | KTT | Class II | 2021-11-05 |
| K212912 | OneFix Biocomposite Anchors, OneFix Biocomposite Small Anchors, OneFix All Suture Anchors, OneFix Interference Screws, OneFix Cannula System | B-One Ortho, Corp. | MAI | Class II | 2021-11-04 |
| K212937 | Dakota ALIF Plate System | Precision Spine, Inc. | KWQ | Class II | 2021-11-04 |
17,115 clearances in the Orthopedic panel. Data: openFDA.