Review Panel
Orthopedic FDA 510(k) Clearances & Devices
- Cleared Devices
- 17,115
- Product Codes (page)
- 35
- Latest Decision
- 2023-03-22
Clearances · page 17 of 172
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K223837 | SPIRA®-C Integrated Fixation System | Camber Spine Technologies | OVE | Class II | 2023-03-22 |
| K223889 | Stativ® Knotted UHMWPE Suture Anchor | Healthium Medtech Limited | MBI | Class II | 2023-03-22 |
| K220464 | Tigon Medical Gryphon Anchor Line | Tigon Medical | MBI | Class II | 2023-03-22 |
| K223708 | Entasis 3D Dual-Lead Sacroiliac Implant System | Corelink, LLC | OUR | Class II | 2023-03-21 |
| K230471 | LinkSymphoKnee Fixed Bearing Ultracongruent (FB UC) Articulating Surface | Waldemar Link GmbH & Co. KG | JWH | Class II | 2023-03-21 |
| K230054 | DSM Biomedical Calcium Phosphate Cement | Dsm Biomedical | MQV | Class II | 2023-03-21 |
| K223043 | The Integrity Spine Core System | Integrity Spine | ODP | Class II | 2023-03-20 |
| K230441 | EMPOWR Stem Extender, 50mm | Encore Medical, L.P Dba Enovis | JWH | Class II | 2023-03-17 |
| K230141 | LOQTEQ® VA Elbow Plates 2.7/3.5 System | Aap Implantate AG | HRS | Class II | 2023-03-17 |
| K230435 | Arthrex 3.9 mm SwiveLock Anchor | Arthrex, Inc. | MAI | Class II | 2023-03-17 |
| K221758 | SMR Stemless Anatomic | Lima Corporate S.P.A. | PKC | Class II | 2023-03-17 |
| K223878 | Aevumed RAPID Suture Anchors | Aevumed, Inc. | MBI | Class II | 2023-03-17 |
| K223418 | DeGen Impulse AM System | Degen Medical | MAX | Class II | 2023-03-17 |
| K223828 | BENCOX Delta Option Heads | Corentec Co., Ltd. | LZO | Class II | 2023-03-16 |
| K220234 | Precice Intramedullary Limb Lengthening System | Nuvasive Specialized Orthopedics, Inc. | HSB | Class II | 2023-03-15 |
| K214001 | Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder System | Biomet Manufacturing Corp | PHX | Class II | 2023-03-15 |
| K223753 | Cervical Plate System | Double Medical Technology, Inc. | KWQ | Class II | 2023-03-14 |
| K223321 | Omnia Medical Coupler-C Anterior Cervical Plate | Omnia Medical, LLC | KWQ | Class II | 2023-03-13 |
| K230295 | ATTUNE® Revision Cones | Depuy Ireland UC | MBH | Class II | 2023-03-10 |
| K230433 | Arthrex Knotless FiberTak Suture Anchor | Arthrex, Inc. | MBI | Class II | 2023-03-10 |
| K221292 | Uni Knee Resurfacing System | Overture Resurfacing, Inc. | HSX | Class II | 2023-03-10 |
| K221919 | DOUBLEFLO INFLOW/OUTFLOW PUMP, accessories and tubing sets | Hemodia Sas | HRX | Class II | 2023-03-09 |
| K223790 | Huvex Interspinous Fusion System | Dio Medical Corp. | PEK | Class II | 2023-03-09 |
| K222007 | Arthrex Virtual Implant Positioning (VIP) System | Arthrex, Inc. | QHE | Class II | 2023-03-08 |
| K230321 | Persona Personalized Knee System | Zimmer, Inc. | JWH | Class II | 2023-03-08 |
| K220966 | SINEFIX | BAAT Medical Products B.V. | MBI | Class II | 2023-03-08 |
| K223688 | CONDUIT Lateral Lumbar Intervertebral Fusion Cage, CONDUIT Instruments | Medos International Sàrl | MAX | Class II | 2023-03-08 |
| K230301 | Athena III Cervical Plate System | Medyssey USA, Inc. | KWQ | Class II | 2023-03-07 |
| K222465 | Tyber Medical Anatomical Plating System | Tyber Medical, LLC | HRS | Class II | 2023-03-07 |
| K230315 | Materialise Shoulder System Materialise Shoulder Guide and Models SurgiCase Shoulder Planner | Materialise NV | QHE | Class II | 2023-03-06 |
| K221621 | Pro-X1 Trochanteric Nailing System | X-Bolt Orthopedics | HSB | Class II | 2023-03-06 |
| K221084 | Dyna Locking Trochanteric Nail | Innosys | HSB | Class II | 2023-03-03 |
| K221697 | INJECTION PIN (KIP(02031-02061) (03031-03061)) | Slk Ortho, LLC | NDN | Class II | 2023-03-03 |
| K223589 | Grappler Suture Anchor R3FLEX IOL System | Paragon 28, Inc. | MBI | Class II | 2023-03-03 |
| K223776 | PEEK Spinal Infusion Cage | Changzhou Geasure Medical Apparatus and Instruments Co., Ltd. | MAX | Class II | 2023-03-03 |
| K221053 | Magnes-C Anterior Cervical Plate System | Fellowship of Orthopaedic Researchers, Inc. | KWQ | Class II | 2023-03-01 |
| K221705 | U2 Total Knee System-PF+ | United Orthopedic Corporation | MBH | Class II | 2023-02-28 |
| K223392 | REVCON (TM) Screw System | Voom Medical Devices, Inc. | HWC | Class II | 2023-02-28 |
| K230245 | LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal Fixation System | L&K BIOMED Co., Ltd. | NKB | Class II | 2023-02-28 |
| K223223 | BENCOX Mirabo Z Cup Cortinium | Corentec Co., Ltd. | LPH | Class II | 2023-02-27 |
| K223075 | Ogmend® Implant Enhancement System | Woven Orthopedic Technologies | QVI | Class II | 2023-02-27 |
| K223582 | MectaLock TI Triple Loaded Suture Anchor | Medacta International S.A. | MBI | Class II | 2023-02-24 |
| K223231 | Ti-Largo Cervical Interbody System | Flospine | ODP | Class II | 2023-02-24 |
| K223852 | VySpan PCT System | Vy Spine, LLC | NKG | Class II | 2023-02-24 |
| K230212 | OrthoButton AL | Riverpoint Medical, LLC | MBI | Class II | 2023-02-23 |
| K222971 | ULTRABUTTON QUAD Adjustable Fixation Device; ULTRABUTTON BB Adjustable Fixation Device; ULTRABUTTON TIB SMALL Adjustable Fixation Device; ULTRABUTTON TIB MEDIUM Adjustable Fixation Device; ULTRABUTTON TIB LARGE Adjustable Fixation Device | Smith & Nephew, Inc. | MBI | Class II | 2023-02-17 |
| K221645 | PROstep(TM) MIS 5mm Chamfer Screw System | Wright Medical Technology | HWC | Class II | 2023-02-17 |
| K213755 | Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT Intervertebral body fusion system | Gbs Commonwealth Co., Ltd. | ODP | Class II | 2023-02-17 |
| K230118 | Bony Trauma Extremity System (BTES) Screw Range, NX Nail | Field Orthopaedics Pty, Ltd. | HWC | Class II | 2023-02-16 |
| K223056 | JAWS Nitinol Staple System | Paragon 28, Inc. | JDR | Class II | 2023-02-16 |
| K223174 | X-Pac Expandable LLIF Cage System | Expanding Innovations, Inc. | MAX | Class II | 2023-02-14 |
| K221490 | Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior Lumbar Cage, Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved Posterior Lumbar Cage, Stryker Spine VLIFT Vertebral Body Replacement System, VLIFT-s Vertebral Body Replacement System, Ascential IBD PEEKc Spacer, Aero-AL Lumbar Cage System, Aero-LL Lumbar Cage System, Aero-C Cervical Cage System, AVS Aria PEEK Spacer, AVS Anchor-C Cervical Cage System, AVS Anchor-L Spacer | Stryker Spine | ODP | Class II | 2023-02-14 |
| K221468 | Citregen Tendon Interference Screw (TIS), Citrelock Tendon Fixation Device, Citrespline and Citrelock ACL Implants | Acuitive Technologies, Inc. | MAI | Class II | 2023-02-14 |
| K223779 | EMPOWR blade stem | Encore Medical, LLC | LPH | Class II | 2023-02-13 |
| K223761 | OIC Intramedullary Screw System | Orthopaedic Implant Company | HWC | Class II | 2023-02-13 |
| K213030 | Curiteva Porous PEEK Cervical Interbody Fusion System | Curiteva, Inc. | ODP | Class II | 2023-02-13 |
| K223786 | Orthex External Fixation System | OrthoPediatrics Corp. | KTT | Class II | 2023-02-10 |
| K223413 | Pisces-SA STANDALONE ALIF Interbody System | Osseus Fusion Systems | OVD | Class II | 2023-02-10 |
| K222041 | CYGNUS-C Standalone ACIF System | GS Medical Co., Ltd. | OVE | Class II | 2023-02-09 |
| K230063 | G Surgical Marksman Spinal Deformity System | G Surgical, LLC | NKB | Class II | 2023-02-09 |
| K223146 | EVOLUTION SPINE Interbody System | Evolution Spine | OVD | Class II | 2023-02-07 |
| K212701 | Eminent Spine 3D Cervical Interbody Fusion System | Eminent Spine | ODP | Class II | 2023-02-06 |
| K222570 | COPAL knee moulds | Heraeus Medical GmbH | JWH | Class II | 2023-02-04 |
| K222574 | Simparo Anchor Line Fixation System | Simparo, Inc. | MBI | Class II | 2023-02-04 |
| K220296 | Manta Ray TDF Spacer | SeaSpine Orthopedics Corporation | ODP | Class II | 2023-02-03 |
| K222063 | MONTAGE Settable, Resorbable Bone Putty | Orthocon, Inc. | MQV | Class II | 2023-02-03 |
| K220337 | GaiaBone Bioabsorbable Bone Graft | Corliber (Shenzhen) Medical Device Co., Ltd. | MQV | Class II | 2023-02-03 |
| K223876 | SMR Shoulder System | Lima Corporate S.P.A. | MBF | Class II | 2023-02-03 |
| K223627 | PreView-III Anterior Cervical Plate System | Nexus Spine, LLC | KWQ | Class II | 2023-02-02 |
| K223406 | SmartRelease Endoscopic Soft Tissue Release System | Microaire Surgical Instruments | HRX | Class II | 2023-02-02 |
| K223362 | Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device | 4Web Medical, Inc. | OVE | Class II | 2023-02-02 |
| K223284 | SutureLoc Implant | Arthrex, Inc. | MBI | Class II | 2023-02-02 |
| K221943 | EmbedMed | 3D Lifeprints UK , Ltd. | PBF | Class II | 2023-02-01 |
| K223348 | My3D® Personalized Pelvic Reconstruction | Onkos Surgical, Inc. | LPH | Class II | 2023-01-30 |
| K213059 | Tibia and Fibula System | Auxein Medical Private Limited | HRS | Class II | 2023-01-27 |
| K222835 | Prophecy Preoperative Navigation Alignment System | Wrightmedicaltechnologyinc | HSN | Class II | 2023-01-27 |
| K222056 | Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | JDI | Class II | 2023-01-26 |
| K222589 | Flexible Suturing System with Anchors (FSSA) | Integrity Orthopaedics, Inc. | MBI | Class II | 2023-01-26 |
| K222665 | Medline UNITE® Ankle Fusion Plating System | Medline Industries, Inc. | HRS | Class II | 2023-01-25 |
| K223563 | OsteoCNX | Converg Engineering | MQV | Class II | 2023-01-25 |
| K221150 | Advanced Bone Plate | Double Medical Technology, Inc. | HRS | Class II | 2023-01-25 |
| K223847 | CREED Cannulated Screws | Glw, Inc. | HWC | Class II | 2023-01-25 |
| K223494 | CD Horizon Spinal System | Medtronic | NKB | Class II | 2023-01-23 |
| K223118 | OIC Variable Angle Small Fragment Locking Plate System | Orthopaedic Implant Company | HRS | Class II | 2023-01-21 |
| K223548 | GMK Sphere & GMK SpheriKA Cementless | Medacta International S.A. | MBH | Class II | 2023-01-20 |
| K223528 | Triathlon® Hinge Knee System | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | KRO | Class II | 2023-01-20 |
| K223521 | ZESPIN SI Joint Fusion System | Aegis Spine, Inc. | OUR | Class II | 2023-01-20 |
| K222554 | EL CAPITAN Anterior Lumbar Interbody Fusion | Astura Medical | OVD | Class II | 2023-01-19 |
| K221726 | Uni-FuZe-C Bone Strip | Zavation Medical Products, LLC | MQV | Class II | 2023-01-18 |
| K223819 | SI-Cure Sacroiliac Joint Fusion System | Alevio, LLC | OUR | Class II | 2023-01-18 |
| K221088 | Anatomic Bone Plate | Double Medical Technology, Inc. | HRS | Class II | 2023-01-18 |
| K223795 | FairFix QT Adjustable Button | Medacta International S.A. | MBI | Class II | 2023-01-17 |
| K223474 | PathLoc-TA Expandable Lumbar Cage System | L&K BIOMED Co., Ltd. | MAX | Class II | 2023-01-13 |
| K220495 | SignaSure Dual Mobility System | Signature Orthopaedics Pty, Ltd. | MEH | Class II | 2023-01-13 |
| K221542 | Galileo Vertebral Body Replacement Device | Bright Spine | PLR | Class II | 2023-01-13 |
| K223731 | NuVasive Modulus-C Interbody System | Nuvasive, Inc. | ODP | Class II | 2023-01-12 |
| K223764 | INFINITY OCT System | Medtronic Sofamor Danek USA, Inc. | NKG | Class II | 2023-01-11 |
| K223719 | Paeon Anterior Cervical Plate System, Elatus Lumbar Plate System | Aegis Spine, Inc. | KWQ | Class II | 2023-01-11 |
| K223181 | NuVasive Reline System | Nu Vasive, Incorporated | NKB | Class II | 2023-01-11 |
| K221090 | Metal Cannulated Screw | Double Medical Technology, Inc. | HWC | Class II | 2023-01-10 |
17,115 clearances in the Orthopedic panel. Data: openFDA.