Instruments for functional explorations and therapeutic interventionsOrthopaedic instruments
Various orthopaedic and traumatology instruments
EMDN code Z121390
Manufacturers registered in Europe (EUDAMED) 71
- On the market
- No longer marketed
- 93/42 Former directive, not yet certified under the MDR
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Other manufacturers known in the United States (FDA) 581
Manufacturers selling this type of device in the United States according to the FDA, not yet in EUDAMED for this category. Some do sell in Europe: registration of devices already on the market is mandatory until 28 November 2026, and some are registered under their parent company’s name. The category is inferred automatically from the US classification and may include related products.
| Manufacturer | Country | Brands | FDA clearance |
|---|---|---|---|
| Smith & Nephew, Inc. Present in Europe in other categories | United States | EVOS SMART TSF ACUFEX ACUFEX TRUNAV TRIGEN MAX | K223112 (2022) |
| Seaspine Orthopedics Corporation | United States | Mariner Specials Mariner Deformity Malibu Coral Mariner MIS | registered |
| MEDTRONIC SOFAMOR DANEK, INC. Present in Europe in other categories | United States | Medtronic Reusable Instruments Medtronic Resuable Instruments CD HORIZON® Spinal System DIAM™ Spinal Stabilization System | registered |
| MEDLINE INDUSTRIES, INC. Present in Europe in other categories | United States | Medline MEDLINE RENEWAL Apollo PENDING | registered |
| ALPHATEC SPINE, INC. | United States | Invictus Arsenal General Instruments General Instrument Zodiac Invictus OsseoScrew | registered |
| DEPUY SPINE, LLC | United States | VSP ISOLA MOSS EXPEDIUM | registered |
| WRIGHT MEDICAL TECHNOLOGY, INC. Present in Europe in other categories | – | CHARLOTTE DARCO SALVATION DART-FIRE TCP | registered |
| Provision | – | Stryker Paragon 28 Synthes Smith and Nephew Arthrex Medartis | registered |
| CG MedTech Co.,Ltd. | South Korea | ANAX™ 5.5 SPINAL SYSTEM Perfix™ Spinal System ANAX 5.5™ Spinal System INNOVERSE Spinal System OPTIMA™ ZS Spinal System Maxima™ ACP System | registered |
| Highridge Medical, LLC | United States | Trinica/Trinica Select Anterior Cervical Plate System Vital Spinal Fixation System Polaris 5.5 Spinal Fixation System LineSider Vital MIS Spinal Fixation System Polaris 4.75 Deformity System | registered |
| Shalby Advanced Technologies, Inc. | United States | Consensus Knee System/Revision Knee System Tahoe Unicompartmental Knee System UniSyn Hip System CS2 Acetabular System Consensus Hip System Revision Knee System | registered |
| BK MEDITECH CO.,LTD. | South Korea | MEGA PLUS SPINE SYSTEM MEGA5.5 SPINE SYSTEM MEGA PLUS MIS SPINE SYSTEM MEGA SPINE SYSTEM PIN SCREW | K061599 (2006) |
| Xtant Medical Holdings, Inc. | United States | Cortera Streamline OCT Streamline TL Spinal Fixation System Cortera Spinal Fixation System Streamline® MIS Spinal Fixation System Cervalign | registered |
| Sequel Medical Inc. | – | Sequel Medical | registered |
| CITIEFFE SRL Present in Europe in other categories | Italy | DOLPHIX ST.A.R. 90 F4 | K150661 (2015) |
| Conmed Corporation Present in Europe in other categories | United States | CONMED Infinity SENTINEL BADGER Y-KNOT C-REAMER | registered |
| ANYBATTERY, INC | United States | Anybattery | registered |
| ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC. | United States | A.T.S.® Personalized Pressure® A.T.S.® ZIMMER® A.T.S.® A.T.S.® 3000 A.T.S.® Tourniquet System | registered |
| STRYKER SUSTAINABILITY SOLUTIONS, INC. | United States | – | registered |
| MEDICALPLASTIC SRL | Italy | ILIZAROV SYSTEMS | registered |
| VILEX IN TENNESSEE, INC. | United States | Vilex Tool Vilex Jones Fracture Tool Orthex Half Pin eZ-Fix Orthex | K163487 (2017) |
| HNM STAINLESS, LLC. | – | HNM MEDICAL | registered |
| GSOURCE LLC | United States | gSource | registered |
| CTL Medical Corporation | United States | GENERIC Surgical Instruments | registered |
| PRECISION SPINE, INC. | United States | Reform MC Screw System NexGen Anterior Cervical Plate System PSS System Reform Ti Modular Reform HA Coated Pedicle Screw System SureLOK MIS 3L | registered |
| Peter Brasseler Holdings, LLC | United States | Brasseler USA SM K-WIRES STEINMANN PINS | registered |
| DE SOUTTER MEDICAL LIMITED | United Kingdom | De Soutter Medical | registered |
| Jeil Medical Corporation Present in Europe in other categories | South Korea | INLET System Surgical Instrument Surgical Instrument Summa Orthopaedics System Surgical Instrument VERUM System Surgical Instrument Prometheus System Surgical Instrument Drill bit | K163308 (2016) |
| Zhejiang Longyou Lande Medical Technology Co., Ltd. | – | Disposable Tourniquet Cuff Reusable Tourniquet Cuff Reusable Conical Cuff Disposable Conical Cuff | registered |
| TORNIER, INC. Present in Europe in other categories | France | Tornier Perform Ortholoc SPS Made-To-Order Wave Calcaneal Fracture Plate MaxLock NexFix | registered |
| Depuy, Inc. | United States | INHANCE INHANCE INTACT GLOBAL STEPTECH INHANCE SHOULDER SYSTEM DELTA XTEND GLOBAL ICON | K770759 (1977) |
| Artisan Power LLC | United States | Artisan Power | registered |
| IN2BONES | United States | NEOFIT Kirschner wire IBS™ In2Bones NEOVIEW | registered |
| Microport Orthopedics Inc. Present in Europe in other categories | United States | Lineage ADVANCE® EVOLUTION® Axiom AXIOM® MicroPort | registered |
| Gebr. Brasseler GmbH & Co. KG | Germany | PIN DRIVER KOMET PIN DRIVER Zimmer® Universal Power System Navigation Pin GUIDE PIN/SCREW | registered |
| GS Medical Co., Ltd. | South Korea | CASSIOPEIA ACP AnyPlus® GSS™ and AnyPlus® Anyplus II Spinal Fixation System GluOn-IF CASSIOPEIA Cervical Plate System | registered |
| Daesung Maref Co., Ltd. Present in Europe in other categories | South Korea | DTS-3000 Tourniquet Cuff | registered |
| MCGINLEY ORTHOPAEDIC INNOVATIONS, LLC | United States | IntelliSense Drill Technology | registered |
| Interstate All Battery Center | – | Interstate All Battery Interstate aAll Battery | registered |
| RENU MEDICAL, INC | United States | Zimmer Tourniquet Stryker Tourniquet | registered |
| Kalitec Direct LLC | – | CosmoLock Pedicle Screw System Cosmolock NIDO Pedicle Screw System Kalitec Special MATIRA ANTERIOR CERVICAL SYSTEM Ocata Anterior Cervical System | registered |
| XENIX MEDICAL LLC | United States | RIVA Posterior Fixation System RIVA Pedicle Screw System | registered |
| Choice Spine, LP | United States | LANCER™/THUNDERBOLT™ Pedicle Screw System FALCON™ Anterior Cervical Plate BLACKBIRD™ Spinal System ORIA Zenith® Cervical Plate System STARFIRE™ Pedicle Screw System | registered |
| aap Implantate AG Present in Europe in other categories | Germany | – | K131459 (2013) |
| Avalign Technologies, Inc. | United States | Millennium Avalign | registered |
| VILEX LLC | United States | TITANEX ARTEMIS FUZE ALPHALOK Plating System Redemption Vilex Tool Dynex | K132820 (2014) |
| KLS-Martin L.P. Present in Europe in other categories | Germany | LEVEL ONE LEVEL ONE TRANSBUCCAL RESORB X PURE PECTUS LEVEL ONE EXTREMITY DRIVER | registered |
| Osteocentric Technologies, Inc. | United States | 3.5mm Countersink 7.0mm Countersink, Cann, Hudson-Mod, 195mm Small Cannulated Countersink AO 125mm 11mm TAP CANNULATED NAV SOLID TAP FOR 7.5mm FASTENER 4.0 X 125MM TAP | registered |
| SIGNUS Medizintechnik GmbH | Germany | DIPLOMAT CONKLUSION DIPLOMAT MIS CYLOX ST ASCOT INSTRUMENT | registered |
| ORTHO-MED, INC. | United States | ORTHOMED | registered |
| SpineArt SA Present in Europe in other categories | Switzerland | ROMEO 2 INSTRUMENTATION ROMEO posterior osteosynthesis system PERLA ® Perla TL MIS SCARLET AC-T PERLA ® TL | registered |
| Integrity Implants Inc. Present in Europe in other categories | United States | – | registered |
| OSTEOMED LLC | United States | OsteoMed | K933101 (1994) |
| Orantech Inc. Present in Europe in other categories | China | Orantech | registered |
| Paradigm Spine GmbH Present in Europe in other categories | – | DSS™ Tap for Screw 5mm HPS Tap for Screw Ø 7mm HPS Tap for Screw Ø 6mm HPS Tap for Screw Ø 8mm HPS Tap for Screw, Ø9mm HPS Tap for Screw Ø 5mm | registered |
| Rti Surgical, Inc. | – | Precision Allograft Cartilage Kit (PACK™) Quantum Spinal Fixation System | registered |
| Tri-Med, Inc. | United States | K-Wires Tools - HCS Tools - LHS Tools-SHD Tools - AFS Tools - HPS | registered |
| LDR Spine Usa, Inc. | – | SpineTune TL Easyspine FacetBRIDGE | registered |
| Paragon 28, Inc. Present in Europe in other categories | United States | Phantom® Fibula Nail System Baby Gorilla®/Gorilla® Plating System Baby Gorilla/Gorilla Plating System Phantom Hindfoot TTC/TC Nail System Monster® Screw System Grappler™ Suture Anchor System | registered |
| Spine Wave, Inc. | United States | Salvo® Spine System Spine Wave Instruments | registered |
| CAMBER SPINE TECHNOLOGIES, LLC | United States | ORTHROS MIS Polyaxial Pedicle Screw ORTHROS MIS ALTIVO™ Anterior Cervical Fixation System SPIRA-C Integrated | registered |
| Micro-Aire Surgical Instruments, Inc. Present in Europe in other categories | United States | MicroAire® | registered |
| NEXXT SPINE, LLC | United States | Inertia® Pedicle Screw System Inertia® MIS Pedicle Screw System Blade® Anterior Cervical Plate System Facet Fixx™ Facet Screw System Inertia® Pedicle Screw and Deformity Correxxion® System Struxxure™ Anterior Cervical Plate and Screws | registered |
| SPINEVISION | United States | P.L.U.S.® UNI-THREAD® | registered |
| BIOMET MICROFIXATION, INC Present in Europe in other categories | United States | LACTOSORB® SYSTEM LACTOSORB* 2.0MM SYSTEM LACTOSORB* SYSTEM LACTOSORB® 1.5MM SYSTEM LACTOSORB® 2.0MM SYSTEM | registered |
| FLOWER ORTHOPEDICS CORPORATION | United States | Flower Orthopedics Active Compression Cannulated Countersink, 3.0/3.5/4.0/4.5 Solid Countersink, 3.0/3.5/4.0/4.5 Self-centering coutersink, small Cannulated Countersink 5.5/6.5/7.3 | registered |
| TREU-Instrumente GmbH | – | TREU | registered |
| Trilliant Surgical, LLC | United States | Arsenal Foot Arsenal Ankle Tiger Gridlock Ankle Washer Countersink Gridlock Ankle Screw Countersink Gridlock Washer Countersink | registered |
| SONTEC INSTRUMENTS, INC. | United States | PIN DRIVER/BONE TAMP VICKERS K-WIRE PIN BENDER PETERSON PIN DRIVER/BENDER PIERMATTEI PIN DRIVER/BENDER PIN DRIVER K-WIRE PIN DRIVER VISE | registered |
| Asp Global, LLC | United States | PERFORMANCE HEALTH ASP MEDICAL | registered |
| GPC MEDICAL LIMITED | India | GPC | registered |
| IMEDICOM CO., LTD. Present in Europe in other categories | South Korea | EZImpactor MEDINAUT MAX MEDINAUT MAX Pro | registered |
| INTEGRA LIFESCIENCES PRODUCTION CORPORATION Present in Europe in other categories | United States | Integra® Jarit® Miltex® | registered |
| TECOMET INC. | United States | Tecomet | registered |
| NVision Biomedical Technologies, Inc. | United States | tangis Healix Vector | registered |
| Saeshin Precision Co., Ltd. | South Korea | TRAUS SSG40 TRAUS SSG40 TD-AUTO TRAUS SSG20 SSG20 | registered |
| Inion Oy Present in Europe in other categories | – | Inion FreedomScrew instruments Inion® Universal instruments | registered |
| MEDULOC, LLC | United States | Meduloc Intramedullary Fracture Fixation (IFF) System | K250316 (2025) |
| TELEFLEX INCORPORATED Present in Europe in other categories | United States | KMEDIC PILLING | registered |
| INNO Holdings, Inc. | United States | Excella II® Excella III-D® Excella® Neuro & Craniofacial Fixation System | registered |
| NOVO SURGICAL, INC. | – | Novo Surgical Inc. Novo Surgical | registered |
| FUSION ORTHOPEDICS, LLC | United States | TopLock FibFix FuzeFix Jones FuzeFix Chamfered Screws | registered |
| INNOMED, INC. Present in Europe in other categories | United States | Innomed, Inc. | registered |
| R & D Batteries, Inc. | United States | R&D Batteries, Inc. | K933337 (1994) |
| Shenzhen Vistar Medical Supplies Co.,Ltd. | China | – | registered |
| Suncoast Dental, Inc | United States | Brasseler | registered |
| ZIMMER BIOMET INC | – | The Tether™ Virage® Vital™ Vitality® Virage® OCT | registered |
| Aegis Spine, Inc. | – | Paeon Posterior Cervical Fixation System ZESPIN SI Joint Fusion System Paeon Anterior Cervical Plate System | registered |
| Insurgical, Inc. | United States | Insurgical, Inc. | K112599 (2012) |
| Intelivation, LLC | – | Golden Isles Pedicle Screw System | registered |
| ORTHO SOLUTIONS HOLDINGS LIMITED | United States | OrthoSolutions 'System26' Bone Screws Volition Plating System ORTHO SOLUTIONS SUCCESSION AFN SYSTEM COGNiTiON™ Staple System Volition™ Plating System | registered |
| AMBLER SURGICAL CORP. | – | Ambler Surgical | registered |
| Acumed LLC | United States | ACUMED | K083144 (2009) |
| BIOPRO, INC. | United States | SCREW D.C. 1.5 x 55mm SCREW D.C. 1.5 x 30mm SCREW D.C. 1.8 x 20mm SCREW D.C. 1.8 x 35mm SCREW D.C. 1.8 x 40mm SCREW D.C. 1.5 x 45mm | K130298 (2013) |
| MEDICREA INTERNATIONAL | France | PASS LP 2.0 PASS LP | registered |
| PARCUS MEDICAL LLC | – | TAP, BONE | registered |
| CAYENNE MEDICAL, INC. | United States | Quattro® Ventix® BioWick X® Tap, for 5.5mm BioWick™ X Implant Tap, for 6.5mm BioWick™ X Implant Tap, Quattro® X3 5.5mm | registered |
| UNIFIED SPINE, LLC | United States | GSO GS1 Spinal System GSO PCT Spinal System GSO GS1 Spacer System | registered |
| ASPEN SURGICAL PRODUCTS, INC. Present in Europe in other categories | United States | Symmetry Surgical Symmetry Bone Symmetry Volkmann Symmetry Volkman Symmetry Emmett | registered |
| GRAMERCY EXTREMITY ORTHOPEDICS LLC | United States | GEO Bone Screw System Jones/5th Metatarsal Bone Screw System EPS Plating System | registered |
The 100 most active manufacturers are shown, out of 581.
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