| Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner (K233408) | Materialise NV | 2023-11-09 |
| INFILOOP® Fixed Loop UHMWPE Suture Titanium Button (K232886) | Healthium Medtech Limited | 2023-11-08 |
| Peridot-EX Expandable Intervertebral Body Fusion System (K232292) | Gbs Commonwealth Co., Ltd. | 2023-11-07 |
| Arthrex FiberTak Suture Anchor (K232742) | Arthrex, Inc. | 2023-11-03 |
| APTUS Cannulated Compression Screws Line Extension, APTUS K-Wire System Line Extension (K232251) | Medartis AG | 2023-11-03 |
| TRAX® CR Total Knee System (K230078) | Amplitude | 2023-11-03 |
| Javelot Ti Suture Anchor, Javelot Ti-D Suture Anchor (K232725) | Suzhou Endophix Co., Ltd. | 2023-11-02 |
| OptiMesh Multiplanar Expandable Interbody Fusion System (K230927) | Spineology, Inc. | 2023-11-01 |
| EVOLUTION® Cement Keel (K231947) | Microport Orthopedics, Inc. | 2023-10-31 |
| Tornier Humeral Nail and Tornier Long Humeral Nail (K230352) | Tornier, Inc. | 2023-10-31 |
| VICTORY™ Lumbar Plate System (K232318) | Globus Medical, Inc. | 2023-10-31 |
| Renova Spine Balloon Catheter (K231340) | Biopsybell S.R.L. | 2023-10-30 |
| ClariVy™ Cervical IBF System (K231836) | Vy Spine, LLC | 2023-10-30 |
| RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion System (K232348) | MiRus, LLC | 2023-10-27 |
| OR3O Dual Mobility Liners (K232667) | Smith & Nephew, Inc. | 2023-10-27 |
| SOLACE Sacroiliac Fixation System (K233241) | Ht Medical, LLC Dba Xenix Medical | 2023-10-27 |
| OGmend® Implant Enhancement System (K233223) | Woven Orthopedic Technologies | 2023-10-26 |
| PressON Spinal Fixation System (K233234) | Nexus Spine, LLC | 2023-10-26 |
| ANAX™ 5.5 Spinal System (K231737) | Innosys Co., Ltd. | 2023-10-26 |
| Newclip Patient-matched instrumentation non sterile PSI (K221615) | Newclip Technics | 2023-10-25 |
| PERLA® TL Posterior Thoraco-lumbar Fixation System (K231069) | Spineart SA | 2023-10-25 |
| Balanced Knee® System TriMax PS Plus Tibial Insert (K233093) | Ortho Development Corporation | 2023-10-25 |
| REUNION Sacroiliac Joint Fusion System (K232211) | Astura Medical | 2023-10-24 |
| Knotilus+ PEEK Knotless Anchor (K232683) | Stryker Endoscopy | 2023-10-24 |
| Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™ Spinal System (K232586) | K&J Consulting Corp. | 2023-10-24 |
| Ripley Spinal Screw System by SAGICO (K232561) | Sagico VA USA, LLC | 2023-10-23 |
| Shadow Knotless All-Suture Anchors (K233258) | Responsive Arthroscopy, LLC | 2023-10-23 |
| Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS Posterior Spinal Fixation System with G21 V-STEADY Bone Cement (K231809) | Ulrich Medical USA | 2023-10-20 |
| Actinia® hip stems (K232371) | Implantcast GmbH | 2023-10-19 |
| KeyLift™ Expandable Interlaminar Stabilization System (K232484) | Amplio Spine, LLC | 2023-10-19 |
| Acro Composites Interbody System (K230478) | Acro Composites, LLC | 2023-10-19 |
| Pro-Link® & Pro-Link® Ti Barbs Cervical Spacer System (K231704) | Life Spine, Inc. | 2023-10-19 |
| Medline UNITE® REFLEX® Nitinol Staple Kit (K232905) | Medline Industries, LP | 2023-10-19 |
| OptiMesh Multiplanar Expandable Interbody Fusion System (K231781) | Spineology, Inc. | 2023-10-18 |
| Arthrex Small External Fixation System (K232897) | Arthrex, Inc. | 2023-10-18 |
| MectaLIF Anterior Lag Extension (K232123) | Medacta International S.A. | 2023-10-18 |
| TransLoc 3D (K232878) | Foundation Fusion Solutions, LLC (Dba Cornerloc) | 2023-10-17 |
| HAtetracell™-C Titanium Cervical IBF System (K231899) | Innovasis, Inc. | 2023-10-17 |
| VyLink™ Spinal Screw System (K231744) | Vy Spine, LLC | 2023-10-13 |
| Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system), Anterior cervical interbody fusion - ACIF (The Peridot-TD Anterior Cervical Intervertebral body fusion system) (K232822) | Gbs Commonwealth Co., Ltd. | 2023-10-13 |
| RIGEL™ 3DR Anterior Cervical Corpectomy System (K232481) | MiRus, LLC | 2023-10-13 |
| Calibrate CCX Interbody System (K232504) | Alphatec Spine, Inc. | 2023-10-13 |
| Stable-L Standalone Lumbar Interbody System (K231486) | Nexus Spine, LLC | 2023-10-12 |
| MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation Devices (K231231) | Paragon 28, Inc. | 2023-10-12 |
| Monkey RingsTM External Fixation System (K232838) | Paragon 28, Inc. | 2023-10-12 |
| Exactech® Vantage® Total Ankle System (K230717) | Exactech, Inc. | 2023-10-12 |
| Vital™ Spinal Fixation System (K230116) | Zimvie Spine (Zimmer Biomet Spine, Inc.) | 2023-10-11 |
| EMPHASYS Femoral Stems (K233233) | Depuy Ireland UC | 2023-10-11 |
| Zeus Spinal System (K230961) | Shanghai Sanyou Medical Co, Ltd. | 2023-10-10 |
| VEOS Spinal Fixation System (K231658) | Spineway | 2023-10-10 |
| CarboClear® Pedicle Screw System (K232341) | CarboFix Orthopedics , Ltd. | 2023-10-10 |
| Vy Spine™ VyLam™ Laminoplasty System (K232471) | Vy Spine, LLC | 2023-10-10 |
| 2.7 mm GRYPHON™ Flex Knotless PEEK Anchor; 2.7 mm GRYPHON™ Flex Knotless Biocomposite Anchor (K232492) | Medos International SARL | 2023-10-06 |
| Ascend VBR System, Ascend NanoTec VBR System (K232173) | Alphatec Spine, Inc. | 2023-10-06 |
| JuggerKnot Soft Anchor OC (K232411) | Riverpoint Medical, LLC | 2023-10-06 |
| Arthrex FiberTape and TigerTape Cerclage Sutures (K232755) | Arthrex, Inc. | 2023-10-06 |
| All-Suture Anchor (K231078) | Riverpoint Medical, LLC | 2023-10-05 |
| OsteoFlo® HydroPutty™ (K231716) | SurGenTec, LLC | 2023-10-02 |
| Intraosseous Fusion Device System (K231649) | Auxano Medical, LLC | 2023-09-29 |
| TriLEAP Plating System (K230591) | Crossroads Extremity Systems | 2023-09-29 |
| KHEIRON® Spinal Fixation System, including patient specific K-ROD (K232650) | S.M.A.I.O | 2023-09-29 |
| Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue® MAX™ + Invue Inset Anterior Cervical Plate System, and FacetFuse® Screw Fixation System (K232605) | Lesspine Innovations | 2023-09-28 |
| ALIGN Radial Head System (K231188) | Skeletal Dynamics, Inc. | 2023-09-28 |
| VariLift®-C Interbody Fusion System (K231076) | Wenzel Spine, Inc. | 2023-09-27 |
| EVOLUTION® Hinge Knee System (K230563) | Microport Orthopedics, Inc. | 2023-09-27 |
| VySpan™ PCT System (K232167) | Vy Spine, LLC | 2023-09-27 |
| Cove Strip, OsteoCove Strip (K232668) | SeaSpine Orthopedics Corporation | 2023-09-27 |
| Invictus® Spinal Fixation System (K232275) | Alphatec Spine, Inc. | 2023-09-27 |
| Arthrex Univers Apex OptiFit Humeral Stem (K230513) | Arthrex, Inc. | 2023-09-26 |
| IdentiTi ALIF Interbody Systems (K232097) | Alphatec Spine, Inc. | 2023-09-25 |
| Exactech Equinoxe PHx Fracture System; Exactech EPIC Screws (K223933) | Exactech, Inc. | 2023-09-25 |
| Cervical Spine Truss System (CSTS) (K231739) | 4Web Medical, Inc. | 2023-09-25 |
| TiLink-P SI Joint Fusion System (K230857) | SurGenTec, LLC | 2023-09-25 |
| Para-Fix External Fixation System (K230067) | New Paradigm Biomedical | 2023-09-22 |
| TriALTIS Spine System (K231479) | Medos International SARL | 2023-09-22 |
| Integrity-SI® Fusion System (K230226) | OsteoCentric Technologies | 2023-09-21 |
| Mpact Extension (K230011) | Medacta International S.A. | 2023-09-20 |
| MedCAD AccuPlan Orthopedics System (K223421) | Medcad | 2023-09-20 |
| Catalyst R1 Reverse Shoulder System (K232583) | Catalyst Orthoscience, Inc. | 2023-09-20 |
| DePuy 3D Additive TriFlange Acetabular Cup and DePuy TriFlange II Acetabular Cup System (K232556) | Depuy Ireland UC | 2023-09-20 |
| CITRELOCK® DUO (K232592) | Acuitive Technologies, Inc. | 2023-09-20 |
| X-Twist Biocomposite Suture Anchor (K232513) | Parcus Medical | 2023-09-18 |
| Stable-L Standalone Lumbar Interbody System, Stable-C Interbody System (K232530) | Nexus Spine, LLC | 2023-09-18 |
| Catalyst Bone Void Filler (K232315) | Ossdsign AB | 2023-09-15 |
| NIDO™ Pedicle Screw System (K230974) | Kalitec Medical | 2023-09-15 |
| Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression Screw System-Medium Product Code ACC-M; Accelerate Compression Screw System-Large Product Code ACC-L (K230946) | Trax Surgical | 2023-09-15 |
| Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter Trays (K223833) | Exactech, Inc. | 2023-09-14 |
| ChoiceSpine Blackhawk Ti Cervical Spacer System (K223869) | Choice Spine, LLC | 2023-09-14 |
| Cove Putty, OsteoCove Putty (K231030) | SeaSpine Orthopedics Corporation | 2023-09-14 |
| Hammerdesis™ Interphalangeal Fusion System (K231147) | Intelivation | 2023-09-14 |
| OSSIOfiber® Cannulated Trimmable Fixation Nail (K230750) | OSSIO , Ltd. | 2023-09-13 |
| Skyway Anterior Cervical Plate System (K231766) | Kyocera Medical Technologies Inc. (KMTI) | 2023-09-12 |
| Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner (K231112) | Materialise NV | 2023-09-12 |
| MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate Fixation (K232154) | MiRus, LLC | 2023-09-11 |
| TITANEX™ MICROBEAM Screw System, TITANEX™ ARTEMIS Screw System (K231504) | Vilex, LLC | 2023-09-11 |
| Legends Orthopedics Suture Anchors (Legends Orthopedics 5.5 mm Suture Anchors, Legends Orthopedics 2.9 mm Suture Anchor, and Legends Orthopedics 5.5 mm Knotless Suture Anchor) (K230517) | Jarmon Medical, LLC (Dba Legends Orthopedics) | 2023-09-11 |
| Vantage® Total Ankle System (K232002) | Exactech, Inc. | 2023-09-11 |
| Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) Inserts (K232426) | Conformis, Inc. | 2023-09-08 |
| Q-FIX ULTRA All-Suture Anchor (K232457) | Smith & Nephew | 2023-09-08 |
| Klassic® Tibial Insert, PS-Post, Klassic All Poly Tibia, PS-Post (K232414) | Total Joint Othopedics, Inc. | 2023-09-08 |