Review Panel
Orthopedic FDA 510(k) Clearances & Devices
- Cleared Devices
- 17,115
- Product Codes (page)
- 39
- Latest Decision
- 2026-07-17
Clearances · page 2 of 172
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| DEN250040 | SportSuite Vision Software | Stryker Endoscopy | SIT | Class II | 2026-07-17 |
| K261309 | Palisades Buttress Plate System | Bethesda Medical Devices, LLC | KWQ | Class II | 2026-07-16 |
| K262032 | TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFR-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFL-SHB );TriMed Non-Spanning Wrist Fusion Plates (NSFR-SHB ) | TriMed, Inc. | HRS | Class II | 2026-07-16 |
| K261271 | Cable-Ready® Cable Grip System | Pioneer Surgical Technology, Inc. | JDQ | Class II | 2026-07-16 |
| K261353 | Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar Anchor System | Kyocera Medical Technologies, Inc. | OVD | Class II | 2026-07-15 |
| K252822 | Atlas Spine HiRISE Expandable Cervical-p Corpectomy Implant | Atlas Spine, Inc. | PLR | Class II | 2026-07-15 |
| K261020 | Symmetrix L Spinal System | Medtronic Sofamor Danek USA, Inc. | MAX | Class II | 2026-07-14 |
| K261284 | Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation System | Alphatec Spine, Inc. | NKB | Class II | 2026-07-14 |
| K261624 | Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained Acetabular Insert; Trident® Crossfire® 0° Polyethylene Insert; Trident ® Crossfire ® 10° Polyethylene Insert;System 12 Crossfire® 10° Insert; Trident® 0° Constrained Acetabular Insert; Trident® Constrained Acetabular Liner;Trident® All Poly Constrained Acetabular Insert; Crossfire® Eccentric Insert 10°; Artisan® Bone Plug;UHR® Universal Head Bipolar Component | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | LPH | Class II | 2026-07-10 |
| K261031 | POSEIDON ST | Signus Medinzintechnik GmbH | MQP | Class II | 2026-07-10 |
| K261968 | Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE suture (72205981); Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one blue knotless and one black MINITAPE suture (72205982) | Smith & Nephew, Inc. | MBI | Class II | 2026-07-09 |
| K261191 | Alians Elbow S | Newclip Technics | HRS | Class II | 2026-07-08 |
| K254130 | C.A. Medical Interbody Fusion System | C.A. Medical, LLC | ODP | Class II | 2026-07-08 |
| DEN250037 | TESSA Spatial Surgery System; INTELLIO Tablet (72205455) | Smith & Nephew, Inc. | SIQ | Class II | 2026-07-06 |
| K261009 | MobileLink Acetabular Cup System 40mm ID Inserts (various) | Waldemar Link GmbH & Co. KG | LZO | Class II | 2026-07-06 |
| K253420 | Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer; Meridian Interbody System; Meridian Anterior Plate System; Reef L Interbody System; Reef TO/TA System; Regatta Lateral System; Regatta Lateral Plate System; Shoreline ACS Interbody System; Shoreline Threaded TruProfile Plate; Shoreline RT Interbody System; Vu Mesh; WaveForm A Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TA Interbody System; WaveForm TO Interbody Sy | SeaSpine Orthopedics Corporation | MAX | Class II | 2026-07-01 |
| K253802 | KHEIRON® Spinal Fixation System, including patient specific K-ROD | S.M.A.I.O | NKB | Class II | 2026-07-01 |
| K261054 | RibPlate System | Stryker Leibinger GmbH & Co KG | HRS | Class II | 2026-07-01 |
| K253434 | OSSTM Orthopedic Salvage System | Biomet, Inc. | JDI | Class II | 2026-07-01 |
| K260556 | Veritas Shoulder System | Restor3D | PHX | Class II | 2026-07-01 |
| K261481 | Pangea Femur Reconstruction System | Stryker GmbH | HSB | Class II | 2026-06-29 |
| K260018 | Arthrex FiberButton | Arthrex, Inc. | MBI | Class II | 2026-06-26 |
| K261351 | SALGINA 2.5mm Distal Radius System | Bonebridge AG | HRS | Class II | 2026-06-26 |
| K253216 | IntraOp Alignment System; CONTOUR3D Bending System | Alphatec Spine, Inc. | SIN | Class II | 2026-06-25 |
| K261458 | ATTUNE Total Knee System; ATTUNE Cementless Knee System | DePuy Ireland UC | JWH | Class II | 2026-06-25 |
| K260809 | Arthrex Sterile VAL and VAL KreuLock Compression Screw System | Arthrex, Inc. | HWC | Class II | 2026-06-25 |
| K261279 | DeltaNEC Interbody System | Nexus Spine | OVE | Class II | 2026-06-22 |
| K253080 | AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02) | Suzhou and Science & Technology Development Corp. | HSB | Class II | 2026-06-18 |
| K252982 | CONDUIT ZERO-P VA Secured Spacer System | Avalign Technologies, Inc. | OVE | Class II | 2026-06-18 |
| K261651 | Precice Max System and Precice Ankle Salvage System | NuVasive Specialized Orthopedics | HSB | Class II | 2026-06-18 |
| K253155 | Fule Metallic Lockable Intramedullary Nail Systems | Beijing Fule Science & Technology Development Co., Ltd. | HSB | Class II | 2026-06-17 |
| K253045 | Socko Vimax Spinal Fixation System | Socko Medical Co., Ltd. | NKB | Class II | 2026-06-17 |
| K261683 | Augment Off-Axis Instrument System | Zimmer, Inc. | PHX | Class II | 2026-06-16 |
| K253374 | LimiFlex® Dynamic Sagittal Tether Instrument Set | Empirical Spine | SGL | Class II | 2026-06-16 |
| K260958 | I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular Stability; I.T.S. Humeral Head Plate with Angular Stability; I.T.S. FR.O.H. Calcaneus Repair System; I.T.S. Pilonplate with Angular Stability; I.T.S. Olecranonplate with Angular Stability; I.T.S. Straight Plate with Angular Stability; I.T.S. Screw System; I.T.S. PRS Sacral Rod System; I.T.S. Fibula Plate PROlock with Angular Stability; I.T.S. Distal Humeral Plates with Angular Stability; I.T.S. LRS (L | I.T.S. GmbH | HRS | Class II | 2026-06-16 |
| K253159 | Prophecy Incompass Surgical Planning System | Wright Medical Technology, Inc. (Stryker) | HSN | Class II | 2026-06-16 |
| K253046 | HERA Interlocking Intramedullary Nailing System | ZheJiang Decans Medical Devices Co., Ltd. | HSB | Class II | 2026-06-16 |
| K260831 | Z1 Hip System | Zimmer, Inc. | LZO | Class II | 2026-06-16 |
| K260036 | NeckTune 3D SA Cervical Cage | Medyssey Co, Ltd. | OVE | Class II | 2026-06-15 |
| K260286 | Dynamo Spinal Cement; Salvo® Spine System | Spine Wave, Inc. | PML | Class II | 2026-06-15 |
| K253151 | Fule Interbody Fusion Cage System | Beijing Fule Science & Technology Development Co., Ltd. | MAX | Class II | 2026-06-15 |
| K260102 | Tornier Perform Reversed Glenoid and Tornier Perform Reversed Augmented Glenoid Shoulder System | Stryker Corporation (Tornier, Inc.) | PHX | Class II | 2026-06-12 |
| K261207 | Exalta Proximal Tibia Plating System | Tyber Medical, LLC | HRS | Class II | 2026-06-12 |
| K254087 | MAXFRAME AUTOSTRUT with Bluetooth Multi-Axial Correction System | Synthes (USA) Products, LLC | KTT | Class II | 2026-06-11 |
| K253115 | LARS ACJ | Movmedix S.A.S. | HTN | Class II | 2026-06-10 |
| K261016 | MSS - Humeral reverse liners extension | Medacta International, SA | PHX | Class II | 2026-06-10 |
| K260810 | Anteralign LS coverplate | Tyber Medical, LLC | OVD | Class II | 2026-06-10 |
| K251251 | ChanPin Pedicle Screw Spinal System | Chanpin Medtak Co., Ltd. | NKB | Class II | 2026-06-09 |
| K260802 | Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner | Materialise NV | QHE | Class II | 2026-06-09 |
| K253066 | ELEOS with NanoCept® Technology Limb Salvage System | Onkos Surgical, Inc. | QZZ | Class II | 2026-06-08 |
| K260761 | APTUS Clavicle System 2.8 | Medartis AG | HRS | Class II | 2026-06-05 |
| K243192 | iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi Coating | Nextstep Arthopedix, LLC | LPH | Class II | 2026-06-05 |
| K253108 | VEOFIX Snap Off Screw | Steps Ortho | HWC | Class II | 2026-06-05 |
| K261510 | Signature ONE System | Orthosoft Inc. (d/b/a) Zimmer CAS | QHE | Class II | 2026-06-04 |
| K260364 | Device 300419 Strip | Geistlich Pharma AG | MQV | Class II | 2026-06-02 |
| K261002 | Pectus Blu System | Biomet Microfixation | HRS | Class II | 2026-06-02 |
| K253195 | TAURUS Posterior Occipital-Cervico-Thoracic Spinal Systems | ZheJiang Decans Medical Devices Co., Ltd. | NKG | Class II | 2026-06-02 |
| K261154 | CoLink® & CoLag® Non-Sterile Screws | In2Bones USA, LLC | HWC | Class II | 2026-05-30 |
| K261159 | Exceed® Biplanar Expandable Interbody System | Spine Wave, Inc. | MAX | Class II | 2026-05-29 |
| K261038 | Xpert PFP | Newclip Technics | HRS | Class II | 2026-05-29 |
| K251840 | Zimmer® Persona® Personalized Knee System | Zimmer, Inc. | MBH | Class II | 2026-05-28 |
| K253931 | Arthrex Bioabsorbable PushLock Suture Anchors | Arthrex, Inc. | MAI | Class II | 2026-05-28 |
| K253894 | BMD Titanium Spinal Fusion System | Global Biomedica s.r.o. | MAX | Class II | 2026-05-28 |
| K252930 | AQUA Laminoplasty Systems | ZheJiang Decans Medical Devices Co., Ltd. | NQW | Class II | 2026-05-27 |
| K253130 | Dione PEEK Screw System | ZheJiang Decans Medical Devices Co., Ltd. | MBI | Class II | 2026-05-27 |
| K261374 | LigaPASS System | Medicrea International S.A.S | OWI | Class II | 2026-05-27 |
| K252797 | JAZBI Resorbable Bone Void Filler | Sdip Innovations Pty, Ltd. | MQV | Class II | 2026-05-26 |
| K252790 | Digital ClarusScope System and Digital NeuroPEN System | Clarus Medical, LLC | HRX | Class II | 2026-05-26 |
| K252887 | DePuy ATTUNE Knee System | DePuy Orthopaedics, Inc. | OIY | Class II | 2026-05-22 |
| K251270 | Taperloc® Complete Hip Stem | Biomet, Inc. | LPH | Class II | 2026-05-19 |
| K260146 | FITBONE® TRANSPORT AND LENGTHENING SYSTEM | Orthofix Srl | HSB | Class II | 2026-05-19 |
| K260840 | BluEX Cervical Expandable Cage System | L&K BIOMED Co., Ltd. | ODP | Class II | 2026-05-16 |
| K260536 | Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone Cement | Depuy Ireland UC | KWL | Class II | 2026-05-15 |
| K260989 | Varion Thoracolumbar Fixation System | Kyocera Medical Technologies Inc. (KMTI) | NKB | Class II | 2026-05-15 |
| K260506 | Ventana® P/T Lumbar Interbody System | Spinal Elements, Inc. | MAX | Class II | 2026-05-15 |
| K261241 | TriMed Compression Screws | TriMed, Inc. | HWC | Class II | 2026-05-14 |
| K252776 | ARIES Anterior Cervical Plate Systems | ZheJiang Decans Medical Devices Co., Ltd. | KWQ | Class II | 2026-05-14 |
| K261363 | Y-Knotless Flex Anchors | CONMED Corporation | MBI | Class II | 2026-05-13 |
| K260850 | OSTEOMNI SPINAL CAGES SYSTEM | Osteomni, Inc. | ODP | Class II | 2026-05-12 |
| K260837 | VersaLift Expandable System | Life Spine, Inc. | MAX | Class II | 2026-05-12 |
| K261145 | Avanti Distal Elbow ORIF System | Avanti Orthopaedics, LLC | HRS | Class II | 2026-05-09 |
| K260385 | aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and transforaminal lumbar interbody system; aprevo® cervical interbody system; corra cervical plating system | Carlsmed, Inc. | MAX | Class II | 2026-05-09 |
| K253991 | Fitbone Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAA | Orthofix Srl | HSB | Class II | 2026-05-08 |
| K254215 | Arthrex Beaming System | Arthrex, Inc. | HWC | Class II | 2026-05-08 |
| K253739 | SCRIPT Rods, CREO Stabilization System, REVERE® Stabilization System, REVERE® 4.5 Stabilization System, NuVasive Reline System | Globus Medical, Inc. | NKB | Class II | 2026-05-07 |
| K253992 | Veritas Reverse Total Shoulder System | Restor3D | PHX | Class II | 2026-05-07 |
| K261112 | CastleLoc-P Anterior Cervical Plate System | L&K BIOMED Co., Ltd. | KWQ | Class II | 2026-05-06 |
| K253027 | Anchor with Fiber Wire and Disposable Inserter | Ortobio S.A. | MBI | Class II | 2026-05-06 |
| K254202 | MectaLIF 3D Metal Anterior | Medacta International S.A. | OVD | Class II | 2026-05-05 |
| K261130 | AccelFix Spinal Fixation System | L&K BIOMED Co., Ltd. | NKB | Class II | 2026-05-05 |
| K253326 | Oxiplex | Fziomed, Inc. | QVL | Class II | 2026-05-01 |
| K254154 | FX V135 EASYTECH® Shoulder System | FX Shoulder Solutions, Inc. | PKC | Class II | 2026-05-01 |
| K254077 | OSSIOfiber® Threaded Trimmable Fixation Nail | OSSIO , Ltd. | HWC | Class II | 2026-05-01 |
| K253966 | PERLA® TL Posterior Thoraco-lumbar Fixation System | Spineart SA | NKB | Class II | 2026-05-01 |
| K252635 | ArthroTAK Tendon Anchor Kit | ArthroTAK, LLC | MBI | Class II | 2026-05-01 |
| K261067 | BEE PLIF Cage | NGMedical GmbH | MAX | Class II | 2026-04-30 |
| K260323 | OrthoPediatrics® Locking Cannulated Blade Plate System | OrthoPediatrics Corp. | HRS | Class II | 2026-04-30 |
| K252542 | LEO Spinal System | ZheJiang Decans Medical Devices Co., Ltd. | NKB | Class II | 2026-04-29 |
| K253401 | SCRIPT Implant System | Globus Medical, Inc. | OVD | Class II | 2026-04-29 |
| K253940 | M.U.S.T. Pedicle Screw System - Extension | Medacta International S.A. | NKB | Class II | 2026-04-28 |
17,115 clearances in the Orthopedic panel. Data: openFDA.