| Arthrex Bioabsorbable PushLock Suture Anchors (K262357) | Arthrex, Inc. | 2026-08-07 |
| Freedom Total Knee System (E-Poly Tibial Liners) (K261563) | Maxx Orthopedics, Inc. | 2026-08-07 |
| Megalodon Dynamic Compression System (K261121) | Paragon 28, Inc. | 2026-08-06 |
| Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee System (K261898) | Howmedica Osteonics Corp. dba Stryker Orthopaedics | 2026-08-06 |
| GFS - Sterile Screws and Top Hat (K253858) | T.A.G. Medical Products Corporation, Ltd. | 2026-08-05 |
| TRIVANCE™ Hip Stem (K254043) | Globus Medical, Inc. | 2026-08-04 |
| Grappler Suture Anchor System (K262047) | Paragon 28, Inc. | 2026-08-03 |
| SABER-XA System (K261408) | Elevation Spine | 2026-08-03 |
| Vertiwedge® Intraosseous System (K261810) | Foundation Surgical Group | 2026-07-31 |
| ZSAlign Cervical Interbody System (K261451) | ZSFab, Inc. | 2026-07-31 |
| Interwedge® Standalone Lateral (K261809) | Foundation Surgical Group | 2026-07-31 |
| ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial Insert) (K262251) | Globus Medical, Inc. | 2026-07-31 |
| AIR+ All-Inside Meniscal Repair Device, Curved Up;AIR+ All-Inside Meniscal Repair Device, Curved Down (K262369) | Stryker Endoscopy | 2026-07-30 |
| Arthrex Radial Head Replacement System (K260624) | Arthrex, Inc. | 2026-07-30 |
| Suture Button Repair System (K261770) | Skeletal Dynamics, Inc. | 2026-07-29 |
| TruLift Expandable System (K261430) | Life Spine, Inc. | 2026-07-28 |
| Xpert Ankle (K261511) | Newclip Technics | 2026-07-28 |
| REMEDY POLY+PLUS SNAP FIT Acetabular Cup (K262290) | Osteoremedies, LLC | 2026-07-24 |
| Tiger 2 System (K253943) | Zavation Medical Products, LLC | 2026-07-24 |
| QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Configuration) (K260362) | MANTIZ Co., Ltd. | 2026-07-24 |
| Klassic Infection Spacer System (K261734) | Total Joint Orthopedics, Inc. | 2026-07-23 |
| 3d Cage Cervical (K253041) | Fims Co., Ltd. | 2026-07-23 |
| Tornier Perform Advanced Glenoid (K260721) | Tornier, Inc. | 2026-07-22 |
| E3D™-C Interbody System (K262094) | Evolution Spine | 2026-07-22 |
| Lapidus Screw Kit (K262075) | Relja Innovations, LLC | 2026-07-22 |
| Versalock Proximal Tibial Plating System (K261406) | GM Dos Reis Industria e Comercio Ltda. | 2026-07-21 |
| Thunderbolt System (K261632) | Responsive Arthroscopy, Inc. | 2026-07-20 |
| Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior Lumbar Cage; Aero® -C Cervical Cage System; AVS® Anchor-C Cervical Cage System; AVS® TL PEEK Spacer; AVS® PL PEEK Spacers; AVS® Navigator PEEK Spacer; AVS® AS PEEK Spacer; Monterey™ AL Interbody System; Aleutian IBF System; Cascadia Interbody System; Chesapeake Stabilization System; Sahara Stabilization System; SANTORINI™ Corpectomy Cage System; MOJAVE Interbody System; VLIFT VERTEBRAL BODY REPLACEM (K262061) | Stryker Spine | 2026-07-17 |
| SportSuite Vision Software (DEN250040) | Stryker Endoscopy | 2026-07-17 |
| Catalyft PL Expandable Interbody System (K253011) | Medtronic Sofamor Danek USA, Inc. | 2026-07-17 |
| 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 ) (K262032) | TriMed, Inc. | 2026-07-16 |
| Cable-Ready® Cable Grip System (K261271) | Pioneer Surgical Technology, Inc. | 2026-07-16 |
| Palisades™ Buttress Plate System (K261309) | Bethesda Medical Devices, LLC | 2026-07-16 |
| Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar Anchor System (K261353) | Kyocera Medical Technologies, Inc. | 2026-07-15 |
| Atlas Spine HiRISE™ Expandable Cervical-p Corpectomy Implant (K252822) | Atlas Spine, Inc. | 2026-07-15 |
| Symmetrix™ L Spinal System (K261020) | Medtronic Sofamor Danek USA, Inc. | 2026-07-14 |
| Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation System (K261284) | Alphatec Spine, Inc. | 2026-07-14 |
| 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 (K261624) | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2026-07-10 |
| POSEIDON ST (K261031) | Signus Medinzintechnik GmbH | 2026-07-10 |
| 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) (K261968) | Smith & Nephew, Inc. | 2026-07-09 |
| Alians Elbow S (K261191) | Newclip Technics | 2026-07-08 |
| C.A. Medical Interbody Fusion System (K254130) | C.A. Medical, LLC | 2026-07-08 |
| TESSA Spatial Surgery System; INTELLIO Tablet (72205455) (DEN250037) | Smith & Nephew, Inc. | 2026-07-06 |
| MobileLink Acetabular Cup System – 40mm ID Inserts (various) (K261009) | Waldemar Link GmbH & Co. KG | 2026-07-06 |
| OSSTM Orthopedic Salvage System (K253434) | Biomet, Inc. | 2026-07-01 |
| KHEIRON® Spinal Fixation System, including patient specific K-ROD (K253802) | S.M.A.I.O | 2026-07-01 |
| 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 (K253420) | SeaSpine Orthopedics Corporation | 2026-07-01 |
| Veritas Shoulder System (K260556) | Restor3D | 2026-07-01 |
| RibPlate System (K261054) | Stryker Leibinger GmbH & Co KG | 2026-07-01 |
| Pangea Femur Reconstruction System (K261481) | Stryker GmbH | 2026-06-29 |
| SALGINA 2.5mm Distal Radius System (K261351) | Bonebridge AG | 2026-06-26 |
| Arthrex FiberButton (K260018) | Arthrex, Inc. | 2026-06-26 |
| ATTUNE Total Knee System; ATTUNE Cementless Knee System (K261458) | DePuy Ireland UC | 2026-06-25 |
| Arthrex Sterile VAL and VAL KreuLock™ Compression Screw System (K260809) | Arthrex, Inc. | 2026-06-25 |
| IntraOp Alignment System; CONTOUR3D Bending System (K253216) | Alphatec Spine, Inc. | 2026-06-25 |
| DeltaNEC Interbody System (K261279) | Nexus Spine | 2026-06-22 |
| CONDUIT™ ZERO-P™ VA Secured Spacer System (K252982) | Avalign Technologies, Inc. | 2026-06-18 |
| Precice™ Max System and Precice™ Ankle Salvage System (K261651) | NuVasive Specialized Orthopedics | 2026-06-18 |
| AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02) (K253080) | Suzhou and Science & Technology Development Corp. | 2026-06-18 |
| “Socko” Vimax Spinal Fixation System (K253045) | Socko Medical Co., Ltd. | 2026-06-17 |
| Fule Metallic Lockable Intramedullary Nail Systems (K253155) | Beijing Fule Science & Technology Development Co., Ltd. | 2026-06-17 |
| Prophecy Incompass Surgical Planning System (K253159) | Wright Medical Technology, Inc. (Stryker) | 2026-06-16 |
| Z1 Hip System (K260831) | Zimmer, Inc. | 2026-06-16 |
| LimiFlex® Dynamic Sagittal Tether Instrument Set (K253374) | Empirical Spine | 2026-06-16 |
| HERA Interlocking Intramedullary Nailing System (K253046) | ZheJiang Decans Medical Devices Co., Ltd. | 2026-06-16 |
| 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 (K260958) | I.T.S. GmbH | 2026-06-16 |
| Augment Off-Axis Instrument System (K261683) | Zimmer, Inc. | 2026-06-16 |
| Fule Interbody Fusion Cage System (K253151) | Beijing Fule Science & Technology Development Co., Ltd. | 2026-06-15 |
| NeckTune™ 3D SA Cervical Cage (K260036) | Medyssey Co, Ltd. | 2026-06-15 |
| Dynamo™ Spinal Cement; Salvo® Spine System (K260286) | Spine Wave, Inc. | 2026-06-15 |
| Exalta Proximal Tibia Plating System (K261207) | Tyber Medical, LLC | 2026-06-12 |
| Tornier Perform Reversed Glenoid and Tornier Perform Reversed Augmented Glenoid Shoulder System (K260102) | Stryker Corporation (Tornier, Inc.) | 2026-06-12 |
| MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction System (K254087) | Synthes (USA) Products, LLC | 2026-06-11 |
| LARS ACJ (K253115) | Movmedix S.A.S. | 2026-06-10 |
| MSS - Humeral reverse liners extension (K261016) | Medacta International, SA | 2026-06-10 |
| Anteralign LS coverplate (K260810) | Tyber Medical, LLC | 2026-06-10 |
| Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner (K260802) | Materialise NV | 2026-06-09 |
| ChanPin Pedicle Screw Spinal System (K251251) | Chanpin Medtak Co., Ltd. | 2026-06-09 |
| ELEOS™ with NanoCept® Technology Limb Salvage System (K253066) | Onkos Surgical, Inc. | 2026-06-08 |
| VEOFIX Snap Off Screw (K253108) | Steps Ortho | 2026-06-05 |
| APTUS Clavicle System 2.8 (K260761) | Medartis AG | 2026-06-05 |
| iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi Coating (K243192) | Nextstep Arthopedix, LLC | 2026-06-05 |
| Signature™ ONE System (K261510) | Orthosoft Inc. (d/b/a) Zimmer CAS | 2026-06-04 |
| TAURUS Posterior Occipital-Cervico-Thoracic Spinal Systems (K253195) | ZheJiang Decans Medical Devices Co., Ltd. | 2026-06-02 |
| Pectus Blu System (K261002) | Biomet Microfixation | 2026-06-02 |
| Device 300419 Strip (K260364) | Geistlich Pharma AG | 2026-06-02 |
| CoLink® & CoLag® Non-Sterile Screws (K261154) | In2Bones USA, LLC | 2026-05-30 |
| Xpert PFP (K261038) | Newclip Technics | 2026-05-29 |
| Exceed® Biplanar Expandable Interbody System (K261159) | Spine Wave, Inc. | 2026-05-29 |
| Arthrex Bioabsorbable PushLock Suture Anchors (K253931) | Arthrex, Inc. | 2026-05-28 |
| Zimmer® Persona® Personalized Knee System (K251840) | Zimmer, Inc. | 2026-05-28 |
| BMD Titanium Spinal Fusion System (K253894) | Global Biomedica s.r.o. | 2026-05-28 |
| AQUA Laminoplasty Systems (K252930) | ZheJiang Decans Medical Devices Co., Ltd. | 2026-05-27 |
| Dione PEEK Screw System (K253130) | ZheJiang Decans Medical Devices Co., Ltd. | 2026-05-27 |
| LigaPASS™ System (K261374) | Medicrea International S.A.S | 2026-05-27 |
| Digital ClarusScope System and Digital NeuroPEN System (K252790) | Clarus Medical, LLC | 2026-05-26 |
| JAZBI™ Resorbable Bone Void Filler (K252797) | Sdip Innovations Pty, Ltd. | 2026-05-26 |
| DePuy ATTUNE™ Knee System (K252887) | DePuy Orthopaedics, Inc. | 2026-05-22 |
| Taperloc® Complete Hip Stem (K251270) | Biomet, Inc. | 2026-05-19 |
| FITBONE® TRANSPORT AND LENGTHENING SYSTEM (K260146) | Orthofix Srl | 2026-05-19 |