Review Panel
Orthopedic FDA 510(k) Clearances & Devices
- Cleared Devices
- 17,115
- Product Codes (page)
- 38
- Latest Decision
- 2024-12-02
Clearances · page 9 of 172
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K240475 | Hintermann Series H2 Total Ankle System | Vilex, LLC | HSN | Class II | 2024-12-02 |
| K243375 | Ruthless Spine RJB | Ruthless, LLC Dba Ruthless Spine | QWL | Class II | 2024-11-29 |
| K243408 | TACTIX Vector Syndesmosis System | Vilex, LLC | HTN | Class II | 2024-11-27 |
| K241995 | HyperFlex Bunion Correction System | Footbridge Medical | HRS | Class II | 2024-11-26 |
| K243050 | TriMed Posterior Malleolus Fixation System | TriMed, Inc. | HRS | Class II | 2024-11-26 |
| K242494 | OsseoFit Interfacing Anchor; OsseoFit Bone Tunnel Construct | Riverpoint Medical, LLC | MBI | Class II | 2024-11-26 |
| K243191 | Atlas Spine Lateral Expandable Interbody System | Atlas Spine, Inc. | OVD | Class II | 2024-11-26 |
| K231655 | 4CIS® Chiron Spinal Fixation System | Solco Biomedical Co., Ltd. | NKB | Class II | 2024-11-26 |
| K242253 | JARVIS Glenoid Reverse Shoulder Prosthesis | FH Industrie | PHX | Class II | 2024-11-25 |
| K243162 | World Liner | Signature Orthopaedics Pty, Ltd. | MEH | Class II | 2024-11-25 |
| K233567 | OsteoCoil Nitinol Compression System (Multiple Component PNs) | Flower Orthopedics Corporation Dba Conventus Flower Ortho | HWC | Class II | 2024-11-22 |
| K242543 | Persona the Personalized Knee System (Persona Ti-Nidium PPS Femurs) | Zimmer, Inc. | MBH | Class II | 2024-11-22 |
| K242799 | PliaFX Flo | Lifenet Health | MBP | Class II | 2024-11-21 |
| K242871 | ATTUNE Revision Hinge Knee | Depuy Ireland UC | KRO | Class II | 2024-11-21 |
| K242998 | GMReis Ankle Plating System | GM Dos Reis Industria e Comercio Ltda. | HRS | Class II | 2024-11-21 |
| K242596 | Versalock Mini and Micro Plating System | GM Dos Reis Industria e Comercio Ltda. | HRS | Class II | 2024-11-21 |
| K242414 | TiLink-P Joint Fusion System | SurGenTec, LLC | OUR | Class II | 2024-11-21 |
| K240716 | AETOS Shoulder System Stemless Humeral Prosthesis | Smith & Nephew, Inc. | PKC | Class II | 2024-11-20 |
| K240856 | Hip Spacer Molds; Knee Spacer Molds; Shoulder Spacer Molds | Osartis GmbH | MBB | Class II | 2024-11-20 |
| K242517 | ProAM ACDF System | Pro Surgical, Inc. | OVE | Class II | 2024-11-20 |
| K243323 | Iconix Knotless Anchor | Riverpoint Medical | MBI | Class II | 2024-11-19 |
| K242516 | EUROPA Posterior Cervical Fusion System | MiRus, LLC | NKG | Class II | 2024-11-19 |
| K243277 | Freedom® Medial Congruent Liner | Maxx Orthopedics, Inc. | JWH | Class II | 2024-11-19 |
| K243506 | Montage-XT Settable Bone Putty | Orthocon, Inc. | MQV | Class II | 2024-11-18 |
| K240528 | b-ONE® Total Hip System | B-One Ortho, Corp. | LZO | Class II | 2024-11-15 |
| K242260 | aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAM | Carlsmed, Inc. | ODP | Class II | 2024-11-15 |
| K242079 | Arthrex Elbow Fracture Plating System | Arthrex, Inc. | HRS | Class II | 2024-11-14 |
| K242814 | Tandry Q-Locking Plate System | Microware Precision Co., Ltd. | HRS | Class II | 2024-11-14 |
| K242436 | Proximal Humerus Fixation System | Skeletal Dynamics, Inc. | HRS | Class II | 2024-11-14 |
| K242764 | MediRod Pedicle Screw System | Cmf Medicon Surgical, Inc. | NKB | Class II | 2024-11-13 |
| K243231 | Trigon PEEK HA Wedges | Nvision Biomedical Technologies | PLF | Class II | 2024-11-08 |
| K241802 | Device 300397 Putty | Geistlich Pharma AG | MQV | Class II | 2024-11-08 |
| K243004 | Xpine Spinal Fixation System | Jeil Medical Corporation | NKB | Class II | 2024-11-08 |
| K241636 | MobileLink Acetabular Cup System - Line Extension (Multiple) | Waldemar Link GmbH & Co. KG | LPH | Class II | 2024-11-08 |
| K240415 | Newclip Patient-matched instrumentation non sterile PSI | Newclip Technics | PBF | Class II | 2024-11-07 |
| K242361 | OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System; MESA® Spinal System; MESA® Small Stature Spinal System; CASPIAN® Spinal System; DENALI® Spinal System; DENALI® MI Spinal System; YUKON OCT Spinal System; Xia® 3 Spinal System; K2M Patient Specific; CASCADIA Interbody System; CAYMAN® Plate System; CAYMAN® Plate System-MI | Stryker Spine | KWQ | Class II | 2024-11-07 |
| K242734 | ZSFab Cervical Interbody System; ZSFab Lumbar Interbody System | Zsfab | ODP | Class II | 2024-11-07 |
| K241468 | Vertiwedge® Intraosseous System | Foundation Surgical Group, Inc. | MQP | Class II | 2024-11-07 |
| K242412 | Agility Symmetric Total Knee System | Medisurge, LLC | MBH | Class II | 2024-11-06 |
| K240450 | Citrepore | Acuitive Technologies, Inc. | MQV | Class II | 2024-11-06 |
| K241484 | Atlas Humeral Nail System | Orthopedic Designs North America, Inc. (Odi-Na) | HSB | Class II | 2024-11-05 |
| K243015 | Skyway Anterior Cervical Plate System | Kyocera Medical Technologies, Inc. | KWQ | Class II | 2024-11-05 |
| K243106 | CarboClear® Hybrid Pedicle Screw System | CarboFix Orthopedics , Ltd. | NKB | Class II | 2024-11-05 |
| K242195 | Gemini Cervical Fusion Cage System | ZheJiang Decans Medical Devices Co., Ltd. | ODP | Class II | 2024-11-04 |
| K240388 | Osteotomy Truss System (OTS) | 4Web Medical, Inc. | HRS | Class II | 2024-11-01 |
| K242311 | EXPERT - Flexible Joint Fixation System | GM Dos Reis Industria e Comercio Ltda. | HTN | Class II | 2024-11-01 |
| K242452 | Monkey Bars Pin to Bar External Fixation System | Paragon 28, Inc. | KTT | Class II | 2024-11-01 |
| K241999 | Prophecy Surgical Planning System | Wright Medical Technology, Inc. (Stryker) | HSN | Class II | 2024-11-01 |
| K243381 | Total Wrist Arthroplasty System (TWA) | Skeletal Dynamics, Inc. | JWJ | Class II | 2024-11-01 |
| K242665 | DePuy ATTUNE Total Knee System | Depuy Orthopedics, Inc. | OIY | Class II | 2024-11-01 |
| K242399 | Bonebridge Osteosynthesis Plating System | Bonebridge AG | HRS | Class II | 2024-10-31 |
| K242711 | JOURNEY II Unicompartmental Knee System (JOURNEY II UK) | Smith & Nephew, Inc. | HSX | Class II | 2024-10-30 |
| K241077 | DeGen Medical Patient Specific Implant (PSI) System | Degen Medical | OVD | Class II | 2024-10-29 |
| K243203 | OC JuggerKnotless Soft Anchor; OC JuggerLoop Soft Anchor | Riverpoint Medical | MBI | Class II | 2024-10-29 |
| K243247 | Persona the Personalized Knee System | Zimmer, Inc. | MBH | Class II | 2024-10-29 |
| K240175 | Tigon Medical Fractures, Instability, and Reconstruction (FIRE) | Tigon Medical | HWC | Class II | 2024-10-29 |
| K242350 | Spinal Alignment Solutions Pelvic Incidence (PI) Rod System | Spinal Alignment Solutions, Inc. | NKB | Class II | 2024-10-28 |
| K243137 | Curiteva Porous PEEK Laminoplasty System | Curiteva, Inc. | NQW | Class II | 2024-10-28 |
| K241992 | Catalyft LS Expandable Interbody System | Medtronic Sofamor Danek USA, Inc. | OVD | Class II | 2024-10-28 |
| K243174 | Cadence Ankle PSI System | 3D Systems, Inc. | OYK | Class II | 2024-10-25 |
| K243173 | Salto Talaris Ankle PSI System | 3D Systems, Inc. | OYK | Class II | 2024-10-25 |
| K242984 | BKS Revision System | Ortho Development Corp. | JWH | Class II | 2024-10-25 |
| K240391 | MUTARS® femoral stem cemented 160 mm and 200 mm | Implantcast GmbH | LZO | Class II | 2024-10-24 |
| K242589 | Scarlet® AL-T | Spineart SA | MAX | Class II | 2024-10-23 |
| K242829 | BluEX Lumbar Expandable Cage System | L&K BIOMED Co., Ltd. | MAX | Class II | 2024-10-23 |
| K243007 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | NKB | Class II | 2024-10-23 |
| K242995 | OIC Small / Mini Fragment Plate System | The Orthopaedic Implant Company | HRS | Class II | 2024-10-23 |
| K240783 | Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip Stems | Smith & Nephew, Inc. | JDI | Class II | 2024-10-21 |
| K242554 | Arthrex VAL and VAL KreuLock Compression Screw System | Arthrex, Inc. | HRS | Class II | 2024-10-21 |
| K242813 | Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner | Materialise NV | QHE | Class II | 2024-10-18 |
| K242372 | Mg OSTEOREVIVE, Mg OSTEOCRETE | Bone Solutions, Inc. | MQV | Class II | 2024-10-18 |
| K242868 | Kinos Total Ankle System | Restor3D | HSN | Class II | 2024-10-18 |
| K242899 | NOVA Minimally Invasive System | Baui Biotech Co., Ltd. | NKB | Class II | 2024-10-17 |
| K242784 | Vy Spine VyLam Laminoplasty System | Vy Spine, LLC | NQW | Class II | 2024-10-16 |
| K242833 | Legend® Acetabular Shell | Ortho Development Corp. | LPH | Class II | 2024-10-11 |
| K233947 | KLIMT Expandable Lumbar Interbody Fusion (LIF) Cage System | Ctl Medical Corporation | MAX | Class II | 2024-10-10 |
| K241491 | Blueprint Patient-Specific Instrumentation; Shoulder iD Primary Reversed Glenoid | Stryker Corporation (Tornier, S.A.S.) | PHX | Class II | 2024-10-10 |
| K230325 | GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal System | Greens Surgicals Pvt. , Ltd. | NKB | Class II | 2024-10-10 |
| K241477 | aprevo® anterior lumbar interbody fusion device with interfixation | Carlsmed, Inc. | OVD | Class II | 2024-10-09 |
| K242691 | OsteoCentric Technologies Cannulated Fasteners and Nuts | OsteoCentric Technologies | HWC | Class II | 2024-10-09 |
| K240181 | Clavicle and Scapula System | Auxein Medical Pvt., Ltd. | HRS | Class II | 2024-10-09 |
| K242826 | ProLift Wedge Expandable Spacer System | Life Spine, Inc. | MAX | Class II | 2024-10-08 |
| K242267 | Gemini Medical Cage System | ZheJiang Decans Medical Devices Co., Ltd. | MAX | Class II | 2024-10-08 |
| K242457 | EARP Interbody System | Retropsoas Technologies, LLC | MAX | Class II | 2024-10-07 |
| K242746 | OvertureTi Knee Resurfacing SystemTM | Overture Orthopaedics | HSX | Class II | 2024-10-07 |
| K242375 | OR3O Dual Mobility System | Smith & Nephew, Inc. | LPH | Class II | 2024-10-07 |
| K242084 | EMPHASYS Acetabular Shell with RapiTite HA | Depuy Ireland UC | LPH | Class II | 2024-10-07 |
| K242445 | Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea Tibia Plating System | Stryker GmbH | HRS | Class II | 2024-10-06 |
| K242364 | IdentiTi II Interbody System | Alphatec Spine, Inc. | MAX | Class II | 2024-10-04 |
| K242671 | Treace Medical Concepts (TMC) Screw Fixation System | Treace Medical Concepts, Inc. | HWC | Class II | 2024-10-04 |
| K242343 | BPS Wrist Fracture System | Orthonovis, Inc. | HRS | Class II | 2024-10-04 |
| K240393 | Exactech® TRULIANT® Knee System | Exactech, Inc. | MBH | Class II | 2024-10-03 |
| K241472 | Icona Hip Stem | Corin U.S.A. Limited | MEH | Class II | 2024-10-03 |
| K241487 | Interwedge® Standalone Lateral | Foundation Surgical Group, Inc. | OVD | Class II | 2024-10-02 |
| K241097 | Arthrex Virtual Implant Positioning (VIP) System Software | Arthrex, Inc. | QHE | Class II | 2024-10-02 |
| K242377 | REMEDY Stemmed Knee Spacer System with All-Poly Tibial Component | Osteoremedies, LLC | JWH | Class II | 2024-10-02 |
| K240889 | ARTFX Lumbar PEEK Cages | Artfx Medical | MAX | Class II | 2024-10-02 |
| K241657 | MSFX MIKRON SPINAL FIXATION SYSTEM | Mikron Makina Sanayi VE Ticaret Ltd. Sti. | NKB | Class II | 2024-09-30 |
| K241895 | Cannulated PsiFGuard | Spineguard | SCY | Class II | 2024-09-26 |
| K241815 | Protean Fragment Plating System | Skeletal Dynamics, Inc. | HRS | Class II | 2024-09-26 |
17,115 clearances in the Orthopedic panel. Data: openFDA.