Review Panel
Orthopedic FDA 510(k) Clearances & Devices
- Cleared Devices
- 17,115
- Product Codes (page)
- 37
- Latest Decision
- 2023-08-18
Clearances · page 15 of 172
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K231262 | Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System, Pangea Humerus Plating System | Stryker GmbH | HRS | Class II | 2023-08-18 |
| K231257 | Pangea Utility Plating System, Pangea Platform | Stryker GmbH | HRS | Class II | 2023-08-18 |
| K230690 | Tandry Locking Plate System | Microware Precision Co., Ltd. | HRS | Class II | 2023-08-17 |
| K223709 | Kyphoplasty Balloon Catheter | Jiangsu Changmei Medtech Co., Ltd. | HRX | Class II | 2023-08-16 |
| K232141 | CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System (Modular Extended Tab Head) | Medtronic Sofamor Danek USA, Inc. | NKB | Class II | 2023-08-16 |
| K231829 | Xenix Medical Sacroiliac Fixation System | Ht Medical D.B.A. Xenix Medical | OUR | Class II | 2023-08-15 |
| K231807 | primaLOK SP Interspinous Fusion System | Wenzel Spine, Inc. | PEK | Class II | 2023-08-15 |
| K230607 | SPICCA Cervical Fusion Cages | Southern Medical (Pty) , Ltd. | ODP | Class II | 2023-08-14 |
| K230608 | SPICCA Stand-Alone Cervical Fusion Cages | Southern Medical (Pty) , Ltd. | OVE | Class II | 2023-08-14 |
| K232311 | LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation System | L&K BIOMED Co., Ltd. | NKB | Class II | 2023-08-14 |
| K231905 | Electro-Spec Steri-Caps | Electro-Spec, Inc. | HTY | Class II | 2023-08-14 |
| K231493 | NITINEX Memory Compression Staple | Vilex, LLC | JDR | Class II | 2023-08-11 |
| K231114 | Zimmer® Natural Nail® System Cephalomedullary Nails; Affixus® Natural Nail® Humeral Nail System | Zimmer Switzerland Manufacturing GmbH | HSB | Class II | 2023-08-09 |
| K231376 | Q-FIX With Needles (Q-FIX With Needles, #0 Suture & Q-FIX With Needles, Minitape) | Smith & Nephew, Inc. | MBI | Class II | 2023-08-09 |
| K231885 | Medline UNITE® REFLEX® Nitinol Staple System | Medline Industries, LP | JDR | Class II | 2023-08-09 |
| K231857 | Arthrex TightRope II | Arthrex, Inc. | MBI | Class II | 2023-08-08 |
| K231098 | LineSider® Spinal System | Integrity Implants, Inc. | NKB | Class II | 2023-08-07 |
| K232005 | HEALICOIL PK Suture Anchor with Needles, ULTRATAPE (Blue); HEALICOIL PK Suture Anchor with Needles, ULTRATAPE (Blue Cobraid) | Smith & Nephew, Inc. | MBI | Class II | 2023-08-04 |
| K231333 | STRETTO Cable System | Globus Medical, Inc. | JDQ | Class II | 2023-08-04 |
| K221138 | Titus Titanium Cervical by SAGICO | Sagico VA USA, LLC | OVE | Class II | 2023-08-04 |
| K231404 | T-Button® A Adjustable Loop UHMWPE Suture PEEK Button, Close Button, T-Button® S Adjustable Loop UHMWPE Suture PEEK Button, Open Button | Healthium Medtech Limited | MBI | Class II | 2023-08-04 |
| K231458 | Extremity Staple | Restor3D | JDR | Class II | 2023-08-03 |
| K231654 | NorthStar OCT System | Seaspine, Inc. | NKG | Class II | 2023-08-03 |
| K221894 | Lumbar Expandable lnterbody Spacers -Additional Indications/Implants | Globus Medical, Inc. | MAX | Class II | 2023-08-03 |
| K231831 | TiLink-L Joint Fusion System | Surgentec | OUR | Class II | 2023-08-03 |
| K223114 | Suture Anchors - HTA Headless Titanium Anchor and Zip Anchors | Gm Dos Reis Industria E Comerico Ltda. | MBI | Class II | 2023-08-02 |
| K231942 | Mineral Collagen Composite Bioactive Extra Moldable | Collagen Matrix, Inc. | MQV | Class II | 2023-08-02 |
| K231593 | Sapphire X3 Anterior Cervical Plate System | Spinal Elements, Inc. | KWQ | Class II | 2023-08-02 |
| K231278 | Knotless Suture Anchor | Riverpoint Medical, LLC | MBI | Class II | 2023-08-01 |
| K231931 | Adena-Zina Spinal System | Shanghai Sanyou Medical Co, Ltd. | NKB | Class II | 2023-07-28 |
| K231951 | SI-Cure Sacroiliac Joint Fusion System | Alevio, LLC | OUR | Class II | 2023-07-28 |
| K231236 | IBS-B MIS Beveled Screw System | In2bones USA, LLC | HWC | Class II | 2023-07-27 |
| K220765 | HS Fiber Cerclage | Riverpoint Medical, LLC | JDQ | Class II | 2023-07-26 |
| K222874 | CarboClear Cervical Cage System, CarboClear Cervical VBR System | Carbofix Orthpedics , Ltd. | ODP | Class II | 2023-07-26 |
| K231787 | ecoFIX® | Science & Bio Materials (S.B.M.) Sas | MAI | Class II | 2023-07-26 |
| K231922 | DEPUY SYNTHES MAXFRAME AUTOSTRUT System | DePuy Synthes | KTT | Class II | 2023-07-26 |
| K231275 | Exceed Biplanar Expandable Interbody System | Spine Wave, Inc. | MAX | Class II | 2023-07-25 |
| K231483 | MySpine Unilateral Guides | Medacta International S.A. | PQC | Class II | 2023-07-21 |
| K231516 | INHANCE Shoulder System, Sterile Single Use Instrumentation | Depuy Ireland UC | MBF | Class II | 2023-07-21 |
| K223316 | Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate Retaining Total Knee Replacement System | Conformis, Inc. | MBH | Class II | 2023-07-21 |
| K231799 | INERTIA® CONNEXX Modular Pedicle Screw System | Nexxt Spine, LLC | NKB | Class II | 2023-07-20 |
| K231840 | CastleLoc-S Posterior Cervical Fixation System | L&K BIOMED Co., Ltd. | NKG | Class II | 2023-07-20 |
| K231808 | QUASAR Standalone ACIF System | GS Medical Co., Ltd. | OVE | Class II | 2023-07-20 |
| K231839 | CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate System | L&K BIOMED Co., Ltd. | KWQ | Class II | 2023-07-19 |
| K231448 | TANDEM Hip System | Smith & Nephew, Inc. | LZY | Class II | 2023-07-19 |
| K231292 | TAMINA 3.5mm Proximal Humerus System; POYA 3.5MM Lateral Proximal Tibia System; LORRAINE 3.5mm Distal Humerus System | Bonebridge AG | HRS | Class II | 2023-07-19 |
| K230945 | Forma Medical Headless Compression Screw | Forma Medical, Inc. | HWC | Class II | 2023-07-18 |
| K230257 | Arthrex Intramedullary Nails | Arthrex, Inc. | HSB | Class II | 2023-07-17 |
| K231441 | ARIX Ankle System | Jeil Medical Corporation | HRS | Class II | 2023-07-17 |
| K230462 | OPTIX H2 Patient Specific Instrument System | Vilex, LLC | HSN | Class II | 2023-07-17 |
| K223252 | TRULIANT® E-PX Tibial Inserts; TRULIANT® E-PX Patellas | Exactech, Inc. | JWH | Class II | 2023-07-17 |
| K230846 | iTotal Identity Knee Replacement System; Identity Imprint Knee Replacement System | Conformis, Inc. | JWH | Class II | 2023-07-17 |
| K231460 | FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System, BALTEUM & BALTEUM-ONE Lumbar Plate System, and Osprey Anterior Cervical Plate System | K&J Consulting Corp. | KWQ | Class II | 2023-07-16 |
| DEN230012 | Ruthless Spine RJB | Ruthless, LLC Dba Ruthless Spine | QWL | Class II | 2023-07-14 |
| K231841 | PathLoc SI Joint Fusion System | L&K BIOMED Co., Ltd. | OUR | Class II | 2023-07-14 |
| K231769 | activL® Next Generation Instrumentation | Aesculap Implants Systems, LLC | QLQ | Class II | 2023-07-13 |
| K231438 | Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody System | Alphatec Spine, Inc. | MAX | Class II | 2023-07-13 |
| K231714 | Graftys Quickset | Graftys | MQV | Class II | 2023-07-12 |
| K223631 | Comprehensive Segmental Revision System(SRS) | Biomet Orthopedics | KWT | Class II | 2023-07-12 |
| K231241 | NanoHive Medical Lumbar Interbody System | NanoHive Medical, LLC | MAX | Class II | 2023-07-12 |
| K231925 | MINIMA S System | Lima Corporate S.P.A. | LZO | Class II | 2023-07-11 |
| K231735 | NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody System; NuVasive CoRoent Small Interlock System; NuVasive CoRoent Small Interlock II System; NuVasive CoRoent Small Ti-C System; NuVasive Cohere Cervical Interbody System | Nu Vasive, Incorporated | ODP | Class II | 2023-07-11 |
| K230942 | SPIRA® Posterior Lumbar Spacers | Camber Spine Technologies | MAX | Class II | 2023-07-11 |
| K231528 | Bonalive Orthopedics granules | Bonalive Biomaterials, Ltd. | MQV | Class II | 2023-07-11 |
| K221307 | Edge Upper Cervical System | Spinal Simplicity, LLC | NKG | Class II | 2023-07-10 |
| K231844 | ProMIS Fixation System | Premia Spine, Ltd. | NKB | Class II | 2023-07-07 |
| K231253 | Overture Orthopaedics Patellofemoral System | Overture Resurfacing, Inc. | KRR | Class II | 2023-07-07 |
| K231339 | Tyber Medical Pin and Wire System (various) | Tyber Medical, LLC | HTY | Class II | 2023-07-06 |
| K223806 | VERTICALE® Triangular Fixation System | Silony Medical GmbH | NKB | Class II | 2023-07-06 |
| K231641 | Rotium Bioresorbable Wick | Nanofiber Solutions, LLC | MAI | Class II | 2023-07-05 |
| K222015 | Integral Titanium Cervical Interbody | Nvision Biomedical Technologies, Inc. | ODP | Class II | 2023-07-05 |
| K231280 | CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X Fenestrated Pedicle Screw System with High V+® Bone Cement | CarboFix Orthopedics , Ltd. | NKB | Class II | 2023-07-03 |
| K231689 | iFuse TORQ® Implant System | SI-BONE, Inc. | OUR | Class II | 2023-06-30 |
| K230456 | SGM Femoral Nail System | Changzhou Geasure Medical Apparatus and Instruments Co., Ltd. | HSB | Class II | 2023-06-30 |
| K231252 | Ventana L Spinal System | Spinal Elements, Inc. | MAX | Class II | 2023-06-30 |
| K231585 | Vantage PSI System | 3D Systems, Inc. | OYK | Class II | 2023-06-30 |
| K230595 | OsteoCentric ACL Fixation System | OsteoCentric Technologies | HWC | Class II | 2023-06-29 |
| K231232 | Curiteva Laminoplasty System | Curiteva, Inc. | NQW | Class II | 2023-06-28 |
| K231636 | LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation System. | L&K BIOMED Co., Ltd. | NKB | Class II | 2023-06-27 |
| K223143 | SAGICO Spinal System | Sagico VA USA, LLC | OVE | Class II | 2023-06-26 |
| K230867 | Bone Bolt System | University of Utah, Department of Orthopaedics | HWC | Class II | 2023-06-26 |
| K222592 | AltiVate® Anatomic Shoulder AG e+ with Markers | Encore Medical L.P. | KWS | Class II | 2023-06-23 |
| K230774 | PERLA® TL System; TEKTONA® HV US Bone Cement | Spineart | PML | Class II | 2023-06-23 |
| K230904 | Arthrex Virtual Implant Positioning (VIP) System | Arthrex, Inc. | QHE | Class II | 2023-06-22 |
| K230993 | CODA Anterior Cervical Plate System | Pioneer Surgical Technology, Inc D.B.A Resolve Surgical Tech | KWQ | Class II | 2023-06-20 |
| K223103 | BethaLoc® stem cementless HA | Implantcast GmbH | LZO | Class II | 2023-06-20 |
| K231461 | Smart Correction System (HA Half Pins) | Wishbone Medical, Inc. | KTT | Class II | 2023-06-16 |
| K230894 | NuVasive Modulus ALIF System | Nu Vasive, Incorporated | OVD | Class II | 2023-06-16 |
| K231199 | Solar Lumbar Interbody Fusion System | Degen Medical | MAX | Class II | 2023-06-16 |
| K230762 | EDEN Spinal Fixation MIS System | Jmt Co., Ltd. | NKB | Class II | 2023-06-15 |
| K231109 | Xerxes Hip Stem | Xerxes Arthopedix, LLC | LZO | Class II | 2023-06-15 |
| K231090 | Zevo Anterior Cervical Plate System | Medtronic Sofamor Danek USA, Inc. | KWQ | Class II | 2023-06-15 |
| K230761 | TRIGEN META-NAIL Nail System | Smith & Nephew, Inc. | JDS | Class II | 2023-06-14 |
| K230731 | Zavation ALIF System | Zavation Medical Products, LLC | OVD | Class II | 2023-06-14 |
| K231145 | Axis Anterior Cervical Plate System | Southern Medical (Pty) , Ltd. | KWQ | Class II | 2023-06-13 |
| K230397 | Cut Screw - Percutaneous Compression Screw | GM Dos Reis Industria e Comercio Ltda. | HWC | Class II | 2023-06-12 |
| K230512 | Gamma4 System | Stryker GmbH | HSB | Class II | 2023-06-09 |
| K230744 | Acumed Acutrak 3 Headless Compression Screw System | Acumed, LLC | HWC | Class II | 2023-06-09 |
| K231359 | RODIN Expandable Lumbar Cage System | Ctl Medical Corporation | MAX | Class II | 2023-06-09 |
| K230892 | Fixone Biocomposite Anchor | Aju Pharm Co., Ltd. | MAI | Class II | 2023-06-09 |
17,115 clearances in the Orthopedic panel. Data: openFDA.