Instruments for functional explorations and therapeutic interventionsOrthopaedic instruments
Motorised orthopaedic surgery system instruments
EMDN code Z121305
Manufacturers registered in Europe (EUDAMED) 78
- On the market
- No longer marketed
- 93/42 Former directive, not yet certified under the MDR
- Click a manufacturer to see its full range, a model to open its EUDAMED record.
A model registered in EUDAMED is not necessarily sold in your country. Check availability and CE marking with the manufacturer.
Other manufacturers known in the United States (FDA) 849
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 |
|---|---|---|---|
| Provision | – | Gyrus ACMI Medtronic Stryker Karl Storz Entellus Medical Brasseler | registered |
| Gebr. Brasseler GmbH & Co. KG | Germany | KOMET Surgical Saw Blade Oscillating Saw Blade Sawblade EZ Saw Blade for Stryker® Saw Blade KMS Blade | registered |
| MEDLINE INDUSTRIES, INC. Present in Europe in other categories | United States | Medline Medline Industries, Inc. Bonecam apollo MEDLINE RENEWAL | registered |
| ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC. | United States | Stablecut® Oxford Surgical Blades Stablecut® Vanguard™ Stablecut® Oxford™ | registered |
| MEDTRONIC SOFAMOR DANEK, INC. Present in Europe in other categories | United States | Medtronic Reusable Instruments Medtronic Reusable Instrument ENDOSKELETON® TCS CD HORIZON® SOLERA® VOYAGER™ Spinal System CD HORIZON® Spinal System CD HORIZON® SOLERA® Spinal System | registered |
| Peter Brasseler Holdings, LLC | United States | Brasseler USA NON-BR2000 LARGE BONE BLADES SMALL BONE BLADES BR2000 BLADES STERNUM SAW BLADES Large Bone Blades | registered |
| Smith & Nephew, Inc. Present in Europe in other categories | United States | DYONICS RENOVATION Knee Extraction SYNTHES PyroSphere CMC DYONICS POWER PLATINUM | registered |
| Microport Orthopedics Inc. Present in Europe in other categories | United States | MicroPort AXIOM® SUPERPATH® CONSERVE® PROFEMUR® Lineage | registered |
| Omega Surgical Instruments Inc | United States | – | K933595 (1994) |
| Bien-Air Surgery SA Present in Europe in other categories | Switzerland | Bur PM2-95 80K Diam C Ø6.0 St Bur PM2-70 80K Diam Ø4.0 St Bur PM2-70 80K FC Ø2.0 St Bur PM2-95 80K Diam Ø1.0 St Bur PM2-125 80K Diam Ø4.0 St Bur PM2 80K Steel TD Ø1.1x4 St | registered |
| HPF SRL | Italy | MIS 3.3 REAMER HANDLE ACETABULAR REAMER D75 mm HC STRAIGHT HANDLE UNIVERSAL CONN. HUDSON ACETABULAR REAMER D80 mm HC ACETABULAR REAMER D44 mm HC ACETABULAR REAMER D74 mm HC | registered |
| MEDTRONIC XOMED, INC. Present in Europe in other categories | United States | RAD® ViSAO® ApexCut Oto-Flex Tricut® Indigo | K041985 (2004) |
| Zimmer, Inc. Present in Europe in other categories | United States | Drill bit Persona® drill, ø 6 mm TPP, adapter Pressure Sentinel® Natural-Knee® | K902332 (1990) |
| SURETEK MEDICAL | United States | Reprocessed 2.5mm Straight Shaver Blade Reprocessed Shaver Blade Curved, 60 Deg, Double Serrated Reprocessed 4mm Straight Shaver Blade Reprocessed Shaver Blade Straight 3.5mm Double Serrated Reprocessed Shaver Blade Straight 2.1mm Double Serrated Reprocessed Shaver Blade Straight 3.0mm Double Serrated | registered |
| ALPHATEC SPINE, INC. | United States | General Instruments Invictus Segmental Plating System Insignia Arsenal IdentiTi | K221821 (2022) |
| Nuvasive, Inc. Present in Europe in other categories | United States | PULSE NVM5 Bendini Remote Monitoring Guidance | K162313 (2017) |
| Hager & Meisinger Gesellschaft mit beschränkter Haftung | – | Bone Management OKTAGON® OKTAGON CEREC® | registered |
| Gyrus Acmi, Inc. Present in Europe in other categories | United States | GYRUS ACMI Diego Elite DIEGO | registered |
| ENZTEC LIMITED | New Zealand | Shoulder Lateralisation - Graft Shaper Femoral Head Planer – Large Femoral Head Planer – Small Microport ORD – Locking – Crossbar – Hudson Enztec Reamer - Crossbar - Sz54 Offset Reamer Cover | registered |
| Medicon eG. Chirurgiemechaniker-Genossenschaft | – | Medicon Medicon Epiplating System | registered |
| Acumed LLC | United States | ACUMED | registered |
| Synvasive Technology, Inc. | United States | Stablecut® Stablecut® TruMatch™ Stablecut® PFC Sigma™ Stablecut® AMK® Stablecut® Preservation® Stablecut® LCS® | registered |
| Highridge Medical, LLC | United States | Timberline Lateral Fusion System PathFinder NXT Minimally Invasive Pedicle Screw System Vital MIS Spinal Fixation System Polaris 5.5 Spinal Fixation System Removal Kit Alta ACDF System | registered |
| Micro-Aire Surgical Instruments, Inc. Present in Europe in other categories | United States | MicroAire® | K955591 (1996) |
| Jota AG | Switzerland | JOTA | registered |
| Exactech, Inc. | United States | Equinoxe Vantage GPS Novation Alteon | K960720 (1996) |
| Paragon 28, Inc. Present in Europe in other categories | United States | Lesser Metatarsal Shortening System Baby Gorilla®/Gorilla® Plating System Bun-Yo-Matic™ Lapidus Clamp System Small Bone Phantom Intramedullary Nail System APEX 3D Total Ankle Replacement System FJ2000 System | registered |
| KOROS U.S.A., INC. | United States | Needle Holder Dilator Tube Set, Single Use, Sterile | K120590 (2013) |
| TECOMET INC. | United States | Tecomet | registered |
| HNM STAINLESS, LLC. | – | HNM MEDICAL HNM MEDICAL HTM MEDICAL | registered |
| ORTHO SOLUTIONS HOLDINGS LIMITED | United States | ORTHO SOLUTIONS SUCCESSION AFN SYSTEM Volition™ Plating System COGNiTiON™ Staple System Volition Plating System ORTHO SOLUTIONS ULTOS PLATING SYSTEM ORTHO SOLUTIONS STERILE DRILL BITS | K102743 (2011) |
| NOVASTEP | France | nexis® PECA® 2.0 Airlock® Centrolock® | registered |
| SIGNATURE ORTHOPAEDICS PTY LTD | Australia | Femoral Peg Drill AP Sizer Drill Bit Tibial Post Drill 1.1 x 100 mm Surgibit Drill TriVerse Tibial Post Drill Flexible Driver | registered |
| Seaspine Orthopedics Corporation | United States | Specials Sierra Disc Prep Admiral NorthStar Shoreline ACS | registered |
| DEPUY SPINE, LLC | United States | MOUNTAINEER SKYLINE EAGLE AEGIS | registered |
| Treace Medical Concepts, Inc. | United States | Saw Blade Blade Drill Bit K-Wire Reamer Drill | registered |
| GSOURCE LLC | United States | gSource | registered |
| DE SOUTTER MEDICAL LIMITED | United Kingdom | De Soutter Medical | registered |
| Depuy, Inc. | United States | GLOBAL APG+ GLOBAL STEPTECH APG QUICKSET PINNACLE GLOBAL ADVANTAGE SPECIALIST | registered |
| VILEX IN TENNESSEE, INC. | United States | Vilex Power Accessory Orthex Drill Solid Orthex Drill Cannulated Vilex Cannulated Drill Vilex Tool Vilex Jones Fracture Tool | registered |
| CG MedTech Co.,Ltd. | South Korea | ASPIRON™ ACP SYSTEM Velofix™ SA Cervical Cage ASPIRON™ S ACP SYSTEM Dyna Locking Trochanteric Nail Dyna Locking IM Nail ANAX™ OCT System | registered |
| Techcord co.,Ltd | South Korea | SharkCut | registered |
| Augmedics, Ltd. | Israel | C-arm Ring Adaptor Swivel 5-6 mm universal tool adapter leg up XVS STERILE COMPONENTS KIT Standard perc pin tray, instruments included Perc Pin Adaptor XVS MARKERS FOR ASC KIT 3 SETS PACK | K261854 (2026) |
| WALDEMAR LINK GmbH & Co. KG | Germany | LINK Instruments - Drills, reamers and saw blades LINK Embrace Shoulder System Line Extension Link Embrace Shoulder System - Instruments BiMobile Dual Mobility System - Instruments MobileLink Acetabular Cup System - Instruments Endo-Model Knee System - Instruments | registered |
| Tri-Med, Inc. | United States | Saw Blades Drills Tools - CFS Tools - HCS Tools - LHS Tools-SHD | registered |
| aap Implantate AG Present in Europe in other categories | Germany | – | registered |
| FLOWER ORTHOPEDICS CORPORATION | United States | Flower Orthopedics Flex-Thread Cannulated Drill Bit, 3.0mm Active Compression Cannulated Drill Bit, 4.0mm Drill Bit Kit, 2.0mm | registered |
| VILEX LLC | United States | Vilex Power Accessory Vilex Drill Cannulated ALPHALOK Plating System TITANEX Dynex Vilex Drill | registered |
| Xtant Medical Holdings, Inc. | United States | Silex Sacroiliac Joint Fusion System Spider Cervical Plating System Irix-C Cervical Integrated Fusion System Xspan Laminoplasty Fixation System Cervalign Streamline OCT | registered |
| Jedmed Instrument Co. | United States | JEDMED | registered |
| Tyber Medical, LLC Present in Europe in other categories | United States | A.L.P.S. mvX™ LEOS Cannulated Screw System VOLT™ Wrist Treatment System Cannulated Screw Drill Headed Screw System Instruments Orion Headed Screw System Instruments | registered |
| Ascension Orthopedics, Inc. | – | Integra® PyroSphere® Ascension® NuGrip® CMC Implant System Integra® TITAN™ CAPTURE™ | registered |
| Trilliant Surgical, LLC | United States | Tiger Arsenal Foot Two-Step Hammertoe Arsenal Ankle Stabilization 8mm/10mm Staple Pilot Drill | registered |
| I.T.S. GmbH | Italy | Spiral Drill Step Drill Spiral Drill, Solid Spiral Drill, D=2.5mm, L=305mm, AO Connector PF Lag Screw Tap Gimlet | registered |
| CTL Medical Corporation | United States | GENERIC Surgical Instruments MONDRIAN ALIF | registered |
| EON MEDITECH PRIVATE LIMITED | – | OSSEOUS Burs-Tungsten Carbide OSSEOUS Burs-stainless Steel OSSEOUS Burs-Fine Diamond OSSEOUS Burs-Course Diamond OSSEOUS OSSEOUS Blade-Tonsillectomy and adenoidectomy Blades - M Type | registered |
| Spineup, Inc. | – | Cervical Drill Revision with Stop L11 Cervical Drill Primary with Stop L21 Cervical Tap Primary with Stop L18 Cervical Drill Primary with Stop L22 Cervical Drill Revision with Stop L21 Ball Joint Drill with Stop D3.5xL12 | registered |
| Osteocentric Technologies, Inc. | United States | 4.0 X 235MM DRILL BIT NO SIDE CUTTING 2.7mm Guidewire, Drill Tip, 300mm Drill Extender 6.0 mm Drill 2.74mm Guidewire, Drill Tip SS, 450mm 3.8 X 145mm DRILL BIT CALIBRATED | registered |
| W & H Dentalwerk Bürmoos GmbH Present in Europe in other categories | Austria | Piezomed Pro Accessory SpeedControl SC1 (M-UK1023) Piezomed Pro M-PH350 AMADEO M-UK1023 S-11 AMADEO M-UK1015 | registered |
| Zimmer Surgical SA Present in Europe in other categories | – | Zimmer Biomet™ Zimmer® Universal Power System | registered |
| Omni Life Science, Inc. Present in Europe in other categories | – | APEX Knee System OMNI Interface Acetabular System | registered |
| Avalign Technologies, Inc. | United States | Millennium Avalign | registered |
| CAYENNE MEDICAL, INC. | United States | AperFix® Quattro® SureLock® Drill with Centering Sleeve BioWick SureLock® Ventix® | registered |
| PRECISION SPINE, INC. | United States | Reform POCT System NexGen Anterior Cervical Plate System Slimplicity Anterior Cervical Plate System Reform Pedicle Screw System Dakota ACDF System Slimplicity Plus Anterior Cervical Plating System | registered |
| UNITED ORTHOPEDIC CORP. | Taiwan | U2 Total Knee System U2™ Knee USTAR II Knee System U-Motion II™ U1™ Hip U2™ Hip | registered |
| PARCUS MEDICAL LLC | – | BIT, DRILL Parcus Instrumentation | registered |
| Storz am Mark GmbH Present in Europe in other categories | Germany | STOMA® | registered |
| NEWDEAL | United States | FOREFOOT SOLUTIONS™ PANTA® SURFIX® FOREFOOT II LARGE QWIX® FOREFOOT | registered |
| KATALYST SURGICAL LLC | United States | Titanium Barraquer Curved Needle Holder Titanium Curved Needle Holder Titanium Castroviejo Straight Needle Holder, With Lock, Suture Cutting Titanium Barraquer Curved Needle Holder, With Lock Titanium Curved Needle Holder, With Lock Titanium Barraquer Straight Needle Holder, With Lock , SP=1.0mm Tips | registered |
| Mectron S.P.A. Present in Europe in other categories | Italy | MECTRON | registered |
| American Medicals | – | American Medicals | registered |
| WEXLER SURGICAL, INC. | United States | Wexler Surgical, Inc. SA-DB5 SA-DB2L SA-FB4 SA-DB3 SA-C-FB4L | registered |
| SurGenTec, LLC | United States | ALARA® 11 Gauge Access Needle with Sheath Two Pack- Diamond & Bevel Tip ALARA® 11 Gauge Access Needle Two Pack- Bevel Tip ALARA 11 Gauge Access Needle with Sheath - Bevel Tip ALARA® 11 Gauge Access Needle Two Pack- Diamond & Bevel Tip ALARA® 11 Gauge Access Needle - Diamond Tip ALARA® 11 Gauge Access Needle with Sheath Two Pack- Bevel Tip | K190163 (2019) |
| Inion Oy Present in Europe in other categories | – | Inion CPS™/OTPS™ instrumentation Inion SPINE instrumentation Inion FreedomScrew instruments Inion CompressOn™ Instrument Inion FreedomPin Instruments Inion CPS™ instrumentation | registered |
| CPM Medical Consultants, LLC | – | Fuse ULTRA Foot plating System | registered |
| INVOTEC INTERNATIONAL, INC. | United States | Invotec ENT Bur | registered |
| Globus Medical, Inc. Present in Europe in other categories | United States | VERZERA StelKast Generic Hip instruments StelKast Generic Knee instruments ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | K241525 (2025) |
| Med Saver, Inc. | – | MSI Precision Specialty Instruments | registered |
| TELEFLEX INCORPORATED Present in Europe in other categories | United States | WECK KMEDIC PILLING | registered |
| AMBLER SURGICAL CORP. | – | Ambler Surgical | registered |
| Kalitec Direct LLC | – | CosmoLock Pedicle Screw System Cosmolock MATIRA ANTERIOR CERVICAL SYSTEM Ocata Anterior Cervical System | registered |
| Spierings Orthopaedics B.V. | Netherlands | KINCISE™ System Acetabular Cup Extraction Finisher Blade 54mm KINCISE™ System Acetabular Cup Extraction SST Head 36mm KINCISE™ System Acetabular Cup Extraction Finisher Blade 60mm KINCISE™ System Acetabular Cup Extraction Bolt KINCISE™ System Acetabular Cup Extraction Shaft KINCISE™ System Acetabular Cup Extraction Finisher Blade 50mm | registered |
| DEPUY ORTHOPAEDICS, INC. Present in Europe in other categories | United States | AGILITY QUICKSET S-ROM SPECIALIST SIGMA SOLUTION SYSTEM | registered |
| CITIEFFE SRL Present in Europe in other categories | Italy | Orthopaedic Surgical Instruments Drill bit | registered |
| FUSION ORTHOPEDICS, LLC | United States | LapiLock FuzeFix Chamfered Screws Metalogix Revolution PolyLock Midfoot FibFix TopLock | registered |
| Orthofix US LLC Present in Europe in other categories | United States | ORTHOFIX Orthofix Implantable Bone Screws CENTURION JANUS HALLMARK Firebird SI Fusion | registered |
| ORTHO-MED, INC. | United States | ORTHOMED | registered |
| Saeshin Precision Co., Ltd. | South Korea | TRAUS TRAUS SSG10 SIP20 FT Surgical System TRAUS SSG30 | registered |
| SpineArt SA Present in Europe in other categories | Switzerland | TRYPTIK 2 C-PLATE INSTRUMENTATION SPE-Instrument PERLA ® JULIET ® LL PERLA ® ROMEO 2 INSTRUMENTATION SCARLET AL-T INSTRUMENTATION | registered |
| NVision Biomedical Technologies, Inc. | United States | Healix tangis Vertex Vector Javelin Toejack | registered |
| Surgical Direct, Inc. | United States | Surgical Direct | registered |
| Howmedica Osteonics Corp. Present in Europe in other categories | United States | INSTRUMENT | registered |
| Onpoint Surgical, Inc. | United States | OnPoint Surgical Cart Replacement Velcro for Headset OnPoint Hex Driver OnPoint Fixed Adapter with Drill Array OnPoint Reusable Instrument Kit #2 Surgeon Assistant AR Headset with Prescription Lenses Loupes & Headlight | K241870 (2024) |
| Grace Medical, Inc. | United States | DragonFly™ Skinny BUR, 100MM x 1.4MM DragonFly™ BUR, CTR, EGG, 80MM L, 1.8MM Ø, BurShield DragonFly™ BUR, DMD, RD, 95MM L, 1.8MM Ø DragonFly™ BUR, DMD, RD, 95MM L, 2.3MM Ø, BurShield DragonFly™ BUR, CTR, RD, 80MM L, 1.8MM Ø, BurShield DragonFly™ BUR, CTR, RD, 80MM L, 1.4MM Ø, BurShield | registered |
| Encore Medical, L.P. | United States | DJO SURGICAL | registered |
| ONKOS SURGICAL, INC. | – | ELEOS™ | registered |
| FIELD ORTHOPAEDICS PTY LTD | Australia | FO NX Nail System OCTOPi Suture Anchor System FO Micro Screw System Griplasty System | registered |
| Merete GmbH | Germany | OsteoBridge™ DuoThread™ | registered |
| NUVASIVE SPECIALIZED ORTHOPEDICS, INC. | – | PRECICE® Instruments PRECICE® Trauma Nail System PRECICE® Intramedullary Limb Lengthening System Instrument PRECICE® STRYDE System PRECICE® System PRECICE® Intramedullary Limb Lengthening System | registered |
| Philips Medical Systems Nederland B.V. Present in Europe in other categories | Netherlands | Philips Philips Sentinelle | registered |
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