Review Panel
Orthopedic FDA 510(k) Clearances & Devices
- Cleared Devices
- 17,115
- Product Codes (page)
- 39
- Latest Decision
- 2024-01-12
Clearances · page 13 of 172
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| DEN230015 | Osteoboost Belt | Bone Health Technologies, Inc. | QZO | Class II | 2024-01-12 |
| K231371 | BEE Cervical Cage | NGMedical GmbH | ODP | Class II | 2024-01-12 |
| K233712 | PRIMA Humeral System; PRIMA TT Glenoid | Lima Corporate S.P.A. | MBF | Class II | 2024-01-11 |
| K233944 | CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments | CarboFix Orthopedics , Ltd. | NKB | Class II | 2024-01-10 |
| K231033 | CEPTRE® Knotted UHMWPE Suture PEEK Anchor | Healthium Medtech Limited | MBI | Class II | 2024-01-04 |
| K230507 | Zimed Distal Medial Tibial Plate and Screw System | Zimed Medikal | HWC | Class II | 2024-01-04 |
| K230891 | SURESTITCH UHMWPE Suture PEEK Button Meniscus Repair Implant | Healthium Medtech Limited | MBI | Class II | 2023-12-28 |
| K233659 | Suture Wing | Osteonic Co., Ltd. | MBI | Class II | 2023-12-26 |
| K233300 | POWEReam 1/4 Drive | Stryker Instruments | NKB | Class II | 2023-12-26 |
| K223745 | Novae® Dual Mobility System, Hype® Hip System | Serf | LZO | Class II | 2023-12-22 |
| K233396 | Cannulated Screw System | Smith & Nephew, Inc. | HWC | Class II | 2023-12-21 |
| K233498 | Stryker Orthopaedics Hip Systems Labeling Update | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | LPH | Class II | 2023-12-21 |
| K233423 | Tyber Medical Anatomical Plating System Line extension to the Mini-Frag System | Tyber Medical, LLC | HRS | Class II | 2023-12-21 |
| K233741 | Hoffmann LRF System | Stryker GmbH | KTT | Class II | 2023-12-21 |
| K231099 | SMR Hybrid Glenoid System | Lima Corporate S.P.A. | MBF | Class II | 2023-12-21 |
| K233154 | SkyOPS Orthopedic Plate System | Sky Surgical, LLC | HRS | Class II | 2023-12-21 |
| K233839 | Peridot-PT Anterior Cervical Intervertebral body fusion System; Peridot-PT Intervertebral body fusion system; The Peridot-TD Anterior Cervical Intervertebral body fusion system; The Peridot-TD Intervertebral body fusion system | Gbs Commonwealth Co., Ltd. | ODP | Class II | 2023-12-20 |
| K231968 | Tactoset® Injectable Bone Substitute | Anika Therapeutics, Inc. | MQV | Class II | 2023-12-20 |
| K233017 | TM Plating System | Tyber Medical, LLC | HRS | Class II | 2023-12-20 |
| K230736 | MagnetOs Putty | Kuros Biosciences B.V | MQV | Class II | 2023-12-20 |
| K231556 | SPECTRUM® GV Bone Cement | Osteoremedies, LLC | LOD | Class II | 2023-12-20 |
| K230850 | United Orthopedic Knee Patient Specific Instrumentation | Enhatch, Inc. | OOG | Class II | 2023-12-20 |
| K231526 | CORAIL Cemented Femoral Stem | Depuy Ireland UC | KWY | Class II | 2023-12-19 |
| K232780 | CC-Clip® Implant System | Cc-Instruments, Inc. | HTN | Class II | 2023-12-18 |
| K233607 | MagnetOs Easypack Putty | Kuros Biosciences B.V | MQV | Class II | 2023-12-15 |
| K231447 | Double Internal Joint Stabilizer- Elbow | Skeletal Dynamics, Inc. | OZI | Class II | 2023-12-15 |
| K232394 | Internal Locking Plate and Screw Fixation System | Changzhou Geasure Medical Apparatus and Instruments Co., Ltd. | HRS | Class II | 2023-12-15 |
| K232267 | Precice Max System | Nuvasive Specialized Orthopedics, Incorporated | HSB | Class II | 2023-12-15 |
| K233670 | Ascension Silicone MCP; Ascension Silicone PIP | Ascension Orthopedics, Inc. | KYJ | Class II | 2023-12-14 |
| K231887 | ARIX Ankle Distal Tibia System | Jeil Medical Corporation | HRS | Class II | 2023-12-14 |
| K233594 | Genesys Spine 3DP AIS-C II Cervical Interbody System | Genesys Spine | OVE | Class II | 2023-12-13 |
| K232652 | Anatomical Plating System (various) | Tyber Medical, LLC | HRS | Class II | 2023-12-13 |
| K230872 | Halis Lumbar Cage System, Lydia Anterior Lumbar Fusion System, Dica Direction Changeable Lumbar Cage System, KEYSTONE Cage System | Shanghai Sanyou Medical Co, Ltd. | MAX | Class II | 2023-12-12 |
| K233455 | ARx MIS Spinal Screw System | Life Spine, Inc. | NKB | Class II | 2023-12-12 |
| K232425 | Signature ONE System | Orthosoft Inc. (D/B/A) Zimmer Cas) | QHE | Class II | 2023-12-12 |
| K233684 | TriALTIS Spine System | Medos International SARL | NKB | Class II | 2023-12-12 |
| K232303 | ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM 3DP Technology | Depuy Ireland UC | MBH | Class II | 2023-12-11 |
| K232515 | Valkyrie Thoracic Fixation System | Jm Longyear Manufacturing, LLC D/B/A Able Medical Devices | HRS | Class II | 2023-12-08 |
| K231743 | F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro Lateral Plate System | Corelink, LLC | MAX | Class II | 2023-12-08 |
| K233261 | Global Modular Replacement System | Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics | JDI | Class II | 2023-12-08 |
| K231515 | MySpine Cervical Guides | Medacta International S.A. | QSD | Class II | 2023-12-07 |
| K233429 | OTS 25 (100-1) | Ots Medical , Ltd. | MBI | Class II | 2023-12-07 |
| K233490 | SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE Putty | Bioventus, LLC | MQV | Class II | 2023-12-05 |
| K231923 | Liberty SI Lateral Implant System | Spinal Simplicity, LLC | OUR | Class II | 2023-12-05 |
| K230724 | arcad® 2.0 Duo & Quadro osteosynthesis compressive staples | Novastep | JDR | Class II | 2023-12-04 |
| K232693 | Tyber Medical Distal Radius Plating System | Tyber Medical, LLC | HRS | Class II | 2023-12-04 |
| K231272 | OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable Fixation Nail | OSSIO , Ltd. | HTY | Class II | 2023-12-01 |
| K230639 | Align Cervical Interbody Fusion System | Acuity Surgical Devices, LLC | ODP | Class II | 2023-12-01 |
| K221787 | Auxein's DHS/DCS Plate System | Auxein Medical Private Limited | KTT | Class II | 2023-11-30 |
| K232611 | TruLift Micro Expandable Spacer System & TruLift Expandable Spacer System | Life Spine, Inc. | MAX | Class II | 2023-11-30 |
| K233552 | IDEAL Ziploop | Riverpoint Medical | MBI | Class II | 2023-11-30 |
| K233527 | Minuteman G5 MIS Fusion Plate; Minuteman G1 (Posterior Fusion Plate /HA Posterior Fusion Plate); HA Minuteman G3-R MIS Fusion Plate; Minuteman G3/HA Minuteman G3 MIS Fusion Plate | Spinal Simplicity, LLC | PEK | Class II | 2023-11-29 |
| K232069 | Expandable Lumbar Fusion Cage (Type I,Type II) | Shanghai Reach Medical Instrument Co, Ltd. | MAX | Class II | 2023-11-29 |
| K233414 | Shoreline ACS Interbody System; Shoreline RT Interbody System | SeaSpine Orthopedics Corporation | OVE | Class II | 2023-11-28 |
| K232595 | Kinos Axiom Total Ankle System | Restor3D | HSN | Class II | 2023-11-28 |
| K233332 | Statera-C Spinal System | K&J Consulting Corp. | NKG | Class II | 2023-11-27 |
| K233078 | Posterior Cervical Spine System | Double Medical Technology, Inc. | NKG | Class II | 2023-11-22 |
| K232719 | ProMIS Extension Rod System | Premia Spine, Ltd. | NKB | Class II | 2023-11-21 |
| K233191 | TotalTi ACDF by SAGICO | Spinal Analytics & Geometrical Implant Co, LLC | OVE | Class II | 2023-11-21 |
| K233084 | Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT Intervertebral body fusion system | Gbs Commonwealth Co., Ltd. | ODP | Class II | 2023-11-21 |
| K233245 | MagnetOs Flex Matrix | Kuros Biosciences B.V | MQV | Class II | 2023-11-21 |
| K231975 | PNK Total Knee System | Tjc Life Co., Ltd. | JWH | Class II | 2023-11-21 |
| K231443 | Mini-OSTEO Pedicle Fixation System | Osteomed Indústria E Comércio DE Implantes Ltda | NKB | Class II | 2023-11-21 |
| K233302 | OSSIOfiber® Compression Staple | OSSIO , Ltd. | MNU | Class II | 2023-11-16 |
| K231445 | LINK Embrace Shoulder System - Reverse Configuration | Waldemar Link GmbH & Co. KG | PHX | Class II | 2023-11-16 |
| K231694 | MASADA Modular Spinal Fixation System | Astura Medical | NKB | Class II | 2023-11-16 |
| K232973 | Arthrex Knee FiberTak® Button Suture Anchor | Arthrex, Inc. | MBI | Class II | 2023-11-15 |
| K233468 | Iconix Anchor | Riverpoint Medical | MBI | Class II | 2023-11-14 |
| K230831 | INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible Glenoid | Depuy Ireland UC | MBF | Class II | 2023-11-13 |
| K231911 | Glenoid Reconstruction System Full Wedge Baseplate | Medacta International S.A. | PHX | Class II | 2023-11-09 |
| K233366 | SYMPHONY OCT System | Medos International SARL | NKG | Class II | 2023-11-09 |
| K233408 | Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner | Materialise NV | QHE | Class II | 2023-11-09 |
| K232886 | INFILOOP® Fixed Loop UHMWPE Suture Titanium Button | Healthium Medtech Limited | MBI | Class II | 2023-11-08 |
| K232292 | Peridot-EX Expandable Intervertebral Body Fusion System | Gbs Commonwealth Co., Ltd. | MAX | Class II | 2023-11-07 |
| K232742 | Arthrex FiberTak Suture Anchor | Arthrex, Inc. | MBI | Class II | 2023-11-03 |
| K232251 | APTUS Cannulated Compression Screws Line Extension, APTUS K-Wire System Line Extension | Medartis AG | HWC | Class II | 2023-11-03 |
| K230078 | TRAX® CR Total Knee System | Amplitude | JWH | Class II | 2023-11-03 |
| K232725 | Javelot Ti Suture Anchor, Javelot Ti-D Suture Anchor | Suzhou Endophix Co., Ltd. | MBI | Class II | 2023-11-02 |
| K230927 | OptiMesh Multiplanar Expandable Interbody Fusion System | Spineology, Inc. | OQB | Class II | 2023-11-01 |
| K231947 | EVOLUTION® Cement Keel | Microport Orthopedics, Inc. | JWH | Class II | 2023-10-31 |
| K232318 | VICTORY Lumbar Plate System | Globus Medical, Inc. | KWQ | Class II | 2023-10-31 |
| K230352 | Tornier Humeral Nail and Tornier Long Humeral Nail | Tornier, Inc. | HSB | Class II | 2023-10-31 |
| K231836 | ClariVy Cervical IBF System | Vy Spine, LLC | ODP | Class II | 2023-10-30 |
| K231340 | Renova Spine Balloon Catheter | Biopsybell S.R.L. | NDN | Class II | 2023-10-30 |
| K232667 | OR3O Dual Mobility Liners | Smith & Nephew, Inc. | LPH | Class II | 2023-10-27 |
| K232348 | RIGEL 3DR Standalone Anterior Cervical Interbody Fusion System | MiRus, LLC | OVE | Class II | 2023-10-27 |
| K233241 | SOLACE Sacroiliac Fixation System | Ht Medical, LLC Dba Xenix Medical | OUR | Class II | 2023-10-27 |
| K233223 | OGmend® Implant Enhancement System | Woven Orthopedic Technologies | QVI | Class II | 2023-10-26 |
| K233234 | PressON Spinal Fixation System | Nexus Spine, LLC | NKB | Class II | 2023-10-26 |
| K231737 | ANAX 5.5 Spinal System | Innosys Co., Ltd. | NKB | Class II | 2023-10-26 |
| K233093 | Balanced Knee® System TriMax PS Plus Tibial Insert | Ortho Development Corporation | JWH | Class II | 2023-10-25 |
| K221615 | Newclip Patient-matched instrumentation non sterile PSI | Newclip Technics | PBF | Class II | 2023-10-25 |
| K231069 | PERLA® TL Posterior Thoraco-lumbar Fixation System | Spineart SA | NKB | Class II | 2023-10-25 |
| K232586 | Rexious Spinal Fixation System, Statera Spinal System, Statera-M Spinal System | K&J Consulting Corp. | NKB | Class II | 2023-10-24 |
| K232211 | REUNION Sacroiliac Joint Fusion System | Astura Medical | OUR | Class II | 2023-10-24 |
| K232683 | Knotilus+ PEEK Knotless Anchor | Stryker Endoscopy | MBI | Class II | 2023-10-24 |
| K233258 | Shadow Knotless All-Suture Anchors | Responsive Arthroscopy, LLC | MBI | Class II | 2023-10-23 |
| K232561 | Ripley Spinal Screw System by SAGICO | Sagico VA USA, LLC | NKB | Class II | 2023-10-23 |
| K231809 | Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS Posterior Spinal Fixation System with G21 V-STEADY Bone Cement | Ulrich Medical USA | PML | Class II | 2023-10-20 |
| K230478 | Acro Composites Interbody System | Acro Composites, LLC | ODP | Class II | 2023-10-19 |
17,115 clearances in the Orthopedic panel. Data: openFDA.