| ATTUNE Medial Stabilized (MS) Fixed Bearing (FB) Insert (K211609) | Depuy Ireland UC | 2021-08-25 |
| Advantage-C PEEK Cervical lnterbody Fusion Device (K211501) | Lntelivation, LLC | 2021-08-24 |
| Prime BIOFOAM® Multi-Hole Shells (K201157) | Microport Orthopedics, Inc. | 2021-08-24 |
| BC Reflex Uni Knee System (K211895) | Bodycad Laboratories, Inc. | 2021-08-20 |
| Simplify Disc (K211757) | Nuvasive, Inc. | 2021-08-20 |
| Prime and DYNASTY® Additive Manufacturing Shells (K202705) | Microport Orthopedics, Inc. | 2021-08-20 |
| Omni Foot and Ankle Plating System (K212297) | Extremity Medical, LLC | 2021-08-20 |
| IO Expandable Lumbar Interbody Fusion System (K210800) | MiRus, LLC | 2021-08-20 |
| Auxilock Titanium Interference Screw (K203029) | Auxein Medical Private Limited | 2021-08-20 |
| Inset Reverse Total Shoulder System (K210533) | Shoulder Innovations, Inc. | 2021-08-20 |
| Altus Spine Sochi OCT Spinal System (K210887) | Altus Partners, LLC | 2021-08-20 |
| MOSS VRS Spinal System (K203607) | Biedermann Motech GmbH & Co. KG | 2021-08-20 |
| OsteoProbe (DEN210013) | Active Life Scientific, Inc. | 2021-08-19 |
| Golden Isles Pedicle Screw System (K212185) | Intelivation, LLC | 2021-08-19 |
| QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments (K211957) | Globus Medical, Inc. | 2021-08-18 |
| Journey II Mid-Level Tibial Inserts (K211671) | Smith & Nephew, Inc. | 2021-08-17 |
| Adena-Zina System (K212066) | Shanghai Sanyou Medical Co, Ltd. | 2021-08-16 |
| Insignia Hip Stem (K211703) | Stryker Orthopaedics | 2021-08-16 |
| CPM Medical Consultants Tibial Revision Knee System (K210695) | Cpm Medical Consultants, LLC | 2021-08-16 |
| Tyber Medical Anatomical Plating System (K203817) | Tyber Medical, LLC | 2021-08-13 |
| Prase-C Anterior Cervical Plate System (K211205) | Gbs Commonwealth Co., Ltd. | 2021-08-12 |
| QUANTUM® Patient Specific Instrumentation (PSI) System (K211883) | In2bones Sas | 2021-08-11 |
| Z-LINKPC System (K211993) | Zavation Medical Products, LLC | 2021-08-11 |
| KHEIRON Spinal Fixation System (K211414) | S.M.A.I.O | 2021-08-10 |
| PSX Interbody System (K211873) | Alphatec Spine, Inc. | 2021-08-10 |
| PAO Cortical Screw (K211435) | Medacta International S.A. | 2021-08-06 |
| TriMed Threaded Intramedullary Nail System (K211783) | TriMed, Inc. | 2021-08-06 |
| Lateral Spine Truss System (LSTS) Interbody Fusion Device (K211388) | 4Web Medical, Inc. | 2021-08-05 |
| EMPHASYS Femoral Stems (K211657) | Depuy Ireland UC | 2021-08-05 |
| Tecomet Global Unite Short Stem Instrumentation (K211553) | Symmetry Medical Manufacturing Inc. Dba Tecomet, Inc. | 2021-08-04 |
| Tigon Medical Button System (K211049) | Tigon Medical | 2021-08-04 |
| Alpha Vent PEEK Suture Anchor (K211502) | Stryker Endoscopy | 2021-08-04 |
| Cannulated Fasteners and Nuts (K211290) | OsteoCentric Technologies | 2021-08-03 |
| DEXA-C Cervical Interbody System (K210521) | Aurora Spine, Inc. | 2021-08-02 |
| Summit Patella Plating System (K203408) | Endeavor Orthopaedics, LLC | 2021-07-30 |
| Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal Fixation Systems: (Firebird Deformity Spinal Fixation System, Phoenix MIS Spinal Fixation System, Phoenix CDX MIS Spinal Fixation System, JANUS Midline Fixation Screws, Firebird NXG Spinal Fixation System, JANUS Fenestrated Screws), Connector System, FIREBIRD SI Fusion System (K211710) | Orthofix, Inc. | 2021-07-30 |
| SMART Taylor Spatial Frame (K210953) | Smith & Nephew, Inc. | 2021-07-29 |
| GMK Sphere Revision (K211664) | Medacta International S.A. | 2021-07-29 |
| Catalyst R1 Reverse Shoulder System (K211991) | Catalyst Orthoscience, Inc. | 2021-07-28 |
| Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell, MetaFix™ Hip System, TriFit™ CF and TS Hip Systems, TaperFit™ Hip System, Revival™ Modular Hip System, MiniHip™, Trinity™ Dual Mobility, MobiliT, BiPolar-i, OMNI MOD™ Hip System, OMNI K1 and K2 Hip Systems, OMNI Bipolar Heads, Corin Biolox Delta Ceramic Heads, OMNI Delta Ceramic Heads (K201657) | Corin, Ltd. | 2021-07-28 |
| ELEOS Limb Salvage System (K211677) | Onkos Surgical | 2021-07-28 |
| FINE Osteotomy (K211646) | Bodycad Laboratories, Inc. | 2021-07-28 |
| Integra DigiFuse Cannulated Intramedullary Fusion System,Integra Total Foot System,Integra CAPTURE Screw System & Integra Ti6 Internal Fixation System,Subtalar MBA System,MetaSurg Subtalar Implant,NewDeal BOLD Screw,NewDeal HALLU Lock Plate System,NewDeal HALLU Plates,QWIX Positioning Screw,SPIN Snap-Off Screw,NewDeal TIBIAXYS System (K210016) | Integra LifeSciences Corporation | 2021-07-27 |
| Fixxsure Anterior Lumbar Plate and Screw System (K211932) | Oak Tree Engineering, LLC | 2021-07-27 |
| Flex-Thread™ Distal Fibula lntramedullary Nail System (K212030) | Flower Orthopedics Corporation Dba Conventus Flower | 2021-07-23 |
| Klassic Knee System (K211602) | Total Joint Orthopedics, Inc. | 2021-07-23 |
| IntraLock System (K210159) | Fusion Orthopedics, LLC | 2021-07-23 |
| Blustone Synergy Diamond SA Cervical System (K210382) | Blustone Synergy, LLC | 2021-07-23 |
| POLARSTEM Cemented Femoral Stem (K203175) | Smith & Nephew, Inc. | 2021-07-22 |
| DELTA XTEND Reverse Shoulder System (K203694) | Depuy Ireland UC | 2021-07-22 |
| Medline UNITE® Digital Fusion Screw System (K211944) | Medline Industries, Inc. | 2021-07-22 |
| CD Horizon Spinal System (K211958) | Medtronic Sofamor Danek USA, Inc. | 2021-07-21 |
| Elos® Intramedullary Nailing System (K201147) | Intrauma S.P.A | 2021-07-19 |
| ENNOVATE Spinal System (K210963) | Aesculap Implant Systems, LLC | 2021-07-19 |
| POLARSTEM Calcar Reamer Guide (K211548) | Smith & Nephew, Inc. | 2021-07-19 |
| SureMAX-SA Cervical Standalone System (K211111) | Additive Implants, Inc. | 2021-07-16 |
| Avanti Orthopaedics Ulnar Shortening System (K211592) | Avanti Orthopaedics, Inc. | 2021-07-16 |
| Ignite Stemless Anatomic Shoulder System (K203108) | Ignite Orthopedics, LLC | 2021-07-16 |
| Acumed Clavicle Hook Plating System (K210750) | Acumed, LLC | 2021-07-15 |
| Bencox THR System (K211866) | Corentec Co., Ltd. | 2021-07-14 |
| Pisces Spinal System (K203023) | Ortho Development Corporation | 2021-07-14 |
| Provident II Hip Stems (K201733) | Globus Medical, Inc. | 2021-07-14 |
| Physica LMC Knee System (K211938) | Limacorporate | 2021-07-13 |
| InSpace Subacromial Tissue Spacer System (DEN200039) | Ortho-Space , Ltd. | 2021-07-12 |
| Bone Screws dia. 5,0 mm (K210717) | Lima Corporate S.P.A. | 2021-07-12 |
| Zavation Spinal System (K211113) | Zavation Medical Products, LLC | 2021-07-12 |
| TRUEMED HAND, FOOT AND ANKLE PLATES SYSTEM (K200575) | Truemed Group, LLC | 2021-07-09 |
| PALACOS R pro, PALACOS R+G pro, PALACOS MV+G pro (K210607) | Heraeus Medical GmbH | 2021-07-09 |
| Grappler Suture Anchor System (K211002) | Paragon 28, Inc. | 2021-07-07 |
| SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu a•POD-L NanoMetalene, SeaSpine Vu e•POD System, SeaSpine Vu a•POD Prime NanoMetalene Intervertebral, SeaSpine Shoreline ACS - Anterior Cervical Standalone, SeaSpine Cervical Interbody RT System, SeaSpine Cambria System, SeaSpine Regatta Lateral System, SeaSpine Reef TO/TA System, SeaSpine Reef TH System, SeaSpine Meridian System (K210497) | SeaSpine Orthopedics Corporation | 2021-07-07 |
| Pantheon IBFD (K203003) | Pantheon Spinal | 2021-07-07 |
| LINK Endo-Model Knee System, Femoral Segments (Augments), UHMWPE (K211768) | Waldemar Link GmbH & Co. KG | 2021-06-30 |
| Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus Spinal System, Ceres-C Spinal System, Omega XP Spinal System (K210044) | Spinal Elements, Inc. | 2021-06-30 |
| aprevo Transforaminal IBF (K210542) | Carlsmed, Inc. | 2021-06-30 |
| Smith & Nephew Plates and Screws (K210837) | Smith & Nephew, Inc. | 2021-06-29 |
| Phantom Hindfoot TTC/TC Nail System (K210869) | Paragon 28, Inc. | 2021-06-28 |
| SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV Radiopaque Bone Cement (K211238) | Stryker Instruments | 2021-06-25 |
| SMARTRELEASE Endoscopic Soft Tissue Release System (K211297) | Microaire Surgical Instruments | 2021-06-24 |
| OVOMotion Reverse Shoulder Arthroplasty System (K203375) | Arthrosurface, Inc. | 2021-06-24 |
| LABYRINTH (K211306) | Zavation Medical Products, LLC | 2021-06-24 |
| CervAlign® Anterior Cervical Plate System (K211408) | Pioneer Surgical Technology, Inc. | 2021-06-23 |
| Valkyrie Thoracic Fixation System (K211695) | Jm Longyear Manufacturing, LLC D/B/A Able Medical Devices | 2021-06-23 |
| Mariner Deformity System (K211606) | SeaSpine Orthopedics Corporation | 2021-06-23 |
| Posterior Spinal Fixation System (K201737) | Shanghai Reach Medical Instrument Co, Ltd. | 2021-06-21 |
| LINK Embrace Shoulder System- Anatomical Configuration (K210899) | Waldemar Link GmbH & Co. KG | 2021-06-21 |
| Restor3d Utility Wedge (K201314) | Restor3D, Inc. | 2021-06-17 |
| Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching) (K202806) | Osteonic Co., Ltd. | 2021-06-17 |
| SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar Spacers (K210595) | Camber Spine Technologies, LLC | 2021-06-15 |
| Symmetric Total Knee System (K203779) | Signal Medical Corporation | 2021-06-10 |
| ELEOS Limb Salvage System with BioGrip (K203815) | Onkos Surgical | 2021-06-09 |
| Suture Wing (K202663) | Osteonic Co., Ltd. | 2021-06-07 |
| X-Pac Expandable Lumbar Cage System (K203802) | Expanding Innovations, Inc. | 2021-06-07 |
| Augmented VaultLock Glenoid (K210050) | Arthrex, Inc. | 2021-06-07 |
| Avon Patello-femoral Joint Prosthesis (K211303) | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2021-06-04 |
| Fix2Lock (PEEK Self Punching) (K202763) | Osteonic Co., Ltd. | 2021-06-04 |
| ASTRA Spine System (K211323) | Spinecraft, LLC | 2021-06-03 |
| SeaSpine WaveForm™ A Interbody System (K210583) | SeaSpine Orthopedics Corporation | 2021-06-02 |
| DePuy Synthes 2.7mm Straight and 2.7mm Adaption Plates (Modular Mini Fragment LCP System) (K211051) | DePuy Synthes | 2021-06-02 |
| Arthrex Beveled FT Screws (K210994) | Arthrex, Inc. | 2021-06-01 |
| Axis Charcot Fixation System (K211261) | Extremity Medical, LLC | 2021-05-28 |