Review Panel
Orthopedic FDA 510(k) Clearances & Devices
- Cleared Devices
- 17,115
- Product Codes (page)
- 37
- Latest Decision
- 2021-02-17
Clearances · page 26 of 172
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K210252 | iTotal Identity Cruciate Retaining (CR) Knee Replacement System, iTotal Identity Posterior Stabilizing (PS) Knee Replacement System | Conformis, Inc. | JWH | Class II | 2021-02-17 |
| K203399 | FITBONE(R) TAA | Wittenstein Intens GmbH | HSB | Class II | 2021-02-17 |
| K201391 | Easytech® Anatomical Shoulder System | Fx Shoulder USA, Inc. | PKC | Class II | 2021-02-16 |
| K210035 | ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System, MegaCerfix Anterior Cervical Plate System, Spinema Lumbar Plate System | Aegis Spine | OUR | Class II | 2021-02-16 |
| K202611 | Catalyst OrthoScience R1 Reverse Shoulder System | Catalyst Orthoscience, Inc. | PHX | Class II | 2021-02-12 |
| K200551 | MectaLIF Transforaminal TiPEEK | Medacta Inernational SA | MAX | Class II | 2021-02-12 |
| K203740 | JuggerKnot Soft Anchor | Riverpoint Medical | MBI | Class II | 2021-02-12 |
| K203385 | TenoTac Soft Tissue Fixation System | Paragon 28, Inc. | MBI | Class II | 2021-02-11 |
| K203557 | EMPOWR Dual Mobility Metal Liner, EMPOWR Dual Mobility Poly Bearing | Encore Medical L.P. | LPH | Class II | 2021-02-10 |
| K203319 | SYMPHONY OCT System | Medos International SARL | NKG | Class II | 2021-02-05 |
| K203334 | The Citrefix Knotless Suture Anchor | Acuitive Technologies, Inc. | MAI | Class II | 2021-02-05 |
| K203475 | LimaCorporate Kirschner Wire | Lima Corporate S.P.A. | HTY | Class II | 2021-02-05 |
| K203588 | ELEOS Limb Salvage System | Onkos Surgical | JDI | Class II | 2021-02-05 |
| K200368 | LINK Embrace Shoulder System - Reverse Configuration | Waldemar Link GmbH & Co. KG | PHX | Class II | 2021-02-05 |
| K202872 | Prase PEEK Anterior Cervical Interbody Spacer | Gbs Commonwealth Co., Ltd. | ODP | Class II | 2021-02-04 |
| K200301 | UNiTi ACDF Implant System | Pressio, Inc. | PHQ | Class II | 2021-02-03 |
| K202151 | Smart SPACE Shoulder System | Techmah Medical, LLC | QHE | Class II | 2021-02-03 |
| K203294 | Arthrex Pilon Fusion System | Arthrex, Inc. | HRS | Class II | 2021-02-03 |
| K203420 | EcoFit® Hip System | Implantcast GmbH | LZO | Class II | 2021-02-03 |
| K202027 | Balex bone Expander System | Taeyeon Medical Co., Ltd. | HRX | Class II | 2021-02-03 |
| K203634 | BioPoly Great Toe Hemiarthroplasty Implant | BioPoly, LLC | KWD | Class II | 2021-02-02 |
| K203278 | INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental Plate-Spacer, ELSA Spacers | Globus Medical, Inc. | MAX | Class II | 2021-02-02 |
| K203568 | Hoffmann LRF System | Stryker GmbH | KTT | Class II | 2021-02-01 |
| K203794 | HEALIX Ti Dual Threaded Suture Anchor with DYNATAPE Suture | Medos International SARL | MBI | Class II | 2021-02-01 |
| K201838 | PediFlex Flexible Nail System | OrthoPediatrics Corp. | HTY | Class II | 2021-01-29 |
| K200429 | BEE Cages | NGMedical GmbH | ODP | Class II | 2021-01-29 |
| K203531 | XYPAN Expandable Lumbar Cage System | Aegis Spine, Inc. | MAX | Class II | 2021-01-29 |
| K202398 | Ti3Z Cervical Interbody System | Zavation Medical Products, LLC | ODP | Class II | 2021-01-29 |
| K202878 | Prase-AP Anterior Cervical Plate System | Gbs Commonwealth Co., Ltd. | KWQ | Class II | 2021-01-29 |
| K203474 | Biomet Microfixation RibFix Advantage System | Biomet Micofixation | HRS | Class II | 2021-01-28 |
| K203507 | Vitality® Spinal Fixation System | Zimmer Biomet Spine, Inc. | NKB | Class II | 2021-01-28 |
| K203405 | EVOS Large Fragment Plating System | Smith & Nephew, Inc. | HRS | Class II | 2021-01-27 |
| K200922 | Altus Spine HA Pedicle Screw System | Altus Partners, LLC | NKB | Class II | 2021-01-26 |
| K203482 | M.U.S.T. Pedicle Screw Extension and Long Tab Implants | Medacta International S.A. | NKB | Class II | 2021-01-26 |
| K203327 | VERTACONNECT TLIF Cage | Signus Medizintechnik | MAX | Class II | 2021-01-25 |
| K203373 | Advanced Research Medical Trident SI Screw System | Advanced Research Medical, LLC | OUR | Class II | 2021-01-22 |
| K202858 | Flex-ThreadTM Distal Fibula Intramedullary Nail System | Conventus Orthopaedics, LLC | HSB | Class II | 2021-01-22 |
| K203153 | CREO Stabilization System, Navigation Instruments, ExcelsiusGPS | Globus Medical, Inc. | NKB | Class II | 2021-01-19 |
| K203485 | SnugFit All-Suture Anchor | Medacta International S.A. | MBI | Class II | 2021-01-19 |
| K202833 | Sequel External Fixation Device | Sequel Medical, Inc. | KTT | Class II | 2021-01-19 |
| K201219 | Biocore9 Femoral Head Resurfacing Component | Biocore9, LLC | KXA | Class II | 2021-01-19 |
| K193608 | EBERLE Shaver System C3 and Accessories | Eberle GmbH & Co. KG | HRX | Class II | 2021-01-15 |
| K203381 | Dynanail Mini Hybrid | MedShape, Inc. | HWC | Class II | 2021-01-15 |
| K203683 | CarboClear Lumbar Cage System | Carbofix Orthpedics , Ltd. | MAX | Class II | 2021-01-15 |
| K203678 | CD HORIZON Spinal System | Medtronic Sofamor Danek USA, Inc. | NQP | Class II | 2021-01-15 |
| K203308 | Ali Interbody Fusion System | Raed M. Ali, M.D., Inc. | MAX | Class II | 2021-01-15 |
| K203506 | PERLA® TL posterior osteosynthesis system | Spineart | NKB | Class II | 2021-01-15 |
| K202019 | Maven Patient-Specific Instrumentation | Paragon 28, Inc. | HSN | Class II | 2021-01-14 |
| K203671 | M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System | Medacta International S.A. | OUR | Class II | 2021-01-13 |
| K203105 | Inion CompressOn Screw | Inion OY | HWC | Class II | 2021-01-13 |
| K203129 | NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) System | Precision Spine, Inc. | OVE | Class II | 2021-01-12 |
| K203201 | NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL Interfixated System, Brigade Hyperlordotic System, Brigade Standalone System, Brigade Lateral System, BASE Interfixated Titanium System, Coalesce Thoracolumbar Interbody Fusion System, Cohere Thoracolumbar Interbody System, Modulus XLIF Interbody System, Modulus TLIF Interbody System, Modulus ALIF System | Nu Vasive, Incorporated | MAX | Class II | 2021-01-12 |
| K203526 | C Scope Visualization System | Cit Ortho | HRX | Class II | 2021-01-12 |
| K201471 | M-Vizion Femoral Revision System Extension | Medacta International S.A. | LZO | Class II | 2021-01-11 |
| K202505 | GetSet Surgical GoPLF! Posterior Lateral Fusion System | Getset Surgical, SA | NKB | Class II | 2021-01-11 |
| K202291 | Button Loop | Yunyi (Beijing) Medical Device Co., Ltd. | MBI | Class II | 2021-01-08 |
| K201259 | ORTHOLOC 2 with 3Di Technology Pilon Fracture Plating System | Wrightmedicaltechnologyinc | HRS | Class II | 2021-01-08 |
| K203341 | ACS LD Uni FB Knee System | Implantcast GmbH | HSX | Class II | 2021-01-08 |
| K202488 | ZSFab Cervical Interbody System | Zsfab, Inc. | ODP | Class II | 2021-01-07 |
| K202495 | SIRION Lateral Lumbar Interbody Fusion | Astura Medical, LLC | MAX | Class II | 2021-01-06 |
| K203465 | OSSIOfiber Cannulated Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, Cannulated Design | OSSIO , Ltd. | HTY | Class II | 2021-01-06 |
| K202810 | AutoStrut G2 | Orthospin, Ltd. | KTT | Class II | 2021-01-06 |
| K193497 | Fixone Biocomposite Interference Screw | Aju Pharm Co., Ltd. | HWC | Class II | 2021-01-05 |
| K200491 | Bfix Orthopedic External Fixator Systems | Aike (Shanghai) Medical Instrument Co., Ltd. | KTT | Class II | 2021-01-05 |
| K203239 | Arthrex Low Profile Screws | Arthrex, Inc. | HWC | Class II | 2020-12-30 |
| K203511 | Baby Gorilla/Gorilla Plating System | Paragon 28, Inc. | HRS | Class II | 2020-12-29 |
| K202248 | Attune Revision Sleeve LPS Femoral Adaptors | Depuy Ireland UC | JWH | Class II | 2020-12-28 |
| K201781 | Uni-FuZe-P Bone Putty | Zavation Medical Products, LLC | MQV | Class II | 2020-12-28 |
| K202454 | Smart SPACE Shoulder System | Techmah Medical, LLC | QHE | Class II | 2020-12-28 |
| K200458 | Tailored-C Cervical Interbody Fusion System | Bespoke Technologies | ODP | Class II | 2020-12-28 |
| K202730 | Quadra-P | Medacta International S.A. | LZO | Class II | 2020-12-28 |
| K202637 | F3D Corpectomy System | Corelink, LLC | MQP | Class II | 2020-12-23 |
| K203467 | WishBone Medical Plate and Screw System | Wishbone Medical, Inc. | HWC | Class II | 2020-12-23 |
| K203026 | AltiVate® Anatomic Pegged Glenoid with Markers | Encore Medical L.P. | KWS | Class II | 2020-12-23 |
| K203207 | Omnia Medical TiBrid-SA | Omnia Medical, LLC | OVD | Class II | 2020-12-23 |
| K202348 | External Remote Controller ERC 4P | Nuvasive Specialized Orthopedics, Inc. | HSB | Class II | 2020-12-22 |
| K203447 | iTotal Identity Cruciate Retaining (CR) Total Knee Replacement, iTotal Identity Posterior Stabilizing (PS) Total Knee Replacement | Conformis, Inc. | JWH | Class II | 2020-12-22 |
| K202298 | Lucent XP, Lucent XP Curved | Spinal Elements, Inc. | MAX | Class II | 2020-12-22 |
| K203452 | Nano FortiFix® System | Nanovis, LLC | NKB | Class II | 2020-12-22 |
| K202820 | Australis Anterior Lumbar Cage System | Prism Surgical Designs Pty, Ltd. | MAX | Class II | 2020-12-22 |
| K201287 | Impulse Interbody Fusion System | Degen Medical | MAX | Class II | 2020-12-22 |
| K201643 | ChoiceSpine Tiger Shark Cervical Spacer System | Choice Spine, LLC | ODP | Class II | 2020-12-22 |
| K203445 | Trigon HA Stand-Alone Wedge Fixation System | Nvision Biomedical Technologies, Inc. | PLF | Class II | 2020-12-21 |
| K201113 | Resascope RS-01/B | Advanced Medical Systems Group Srl | HRX | Class II | 2020-12-21 |
| K203125 | Invictus OCT Spinal Fixation System | Alphatec Spine, Inc. | NKG | Class II | 2020-12-18 |
| K202812 | IdentiTi Cervical Standalone Interbody System | Alphatec Spine, Inc. | OVE | Class II | 2020-12-18 |
| K201905 | SMR 140° Reverse Humeral Body | Lima Corporate S.P.A. | MBF | Class II | 2020-12-17 |
| K203222 | PERLA TL Posterior Osteosynthesis System | Spineart | NKB | Class II | 2020-12-17 |
| K203163 | ARx Illiac Spinal Screw System | Life Spine, Inc. | NKB | Class II | 2020-12-17 |
| K202289 | ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA) | Stryker GmbH | KWS | Class II | 2020-12-16 |
| K203414 | DePuy Synthes 2.7mm VA LCP Clavicle Plate System, DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate System | DePuy Synthes | HRS | Class II | 2020-12-16 |
| DEN200035 | BEAR (Bridge-Enhanced ACL Repair) Implant | Miach Orthopaedics, Inc. | QNI | Class II | 2020-12-16 |
| K200291 | CREED Cannulated Screws | Glw Medical, Inc. | HWC | Class II | 2020-12-16 |
| K203180 | Arthrex DynaNite Nitinol Staples | Arthrex, Inc. | JDR | Class II | 2020-12-16 |
| K200549 | Lucero Medical Cervical Cage System | Lucero Medical, LLC | ODP | Class II | 2020-12-16 |
| K202230 | NEXXT MATRIXX Stand Alone ALIF System | Nexxt Spine, LLC | OVD | Class II | 2020-12-15 |
| K192709 | Fixone All Suture Anchor | Aju Pharm Co., Ltd. | MBI | Class II | 2020-12-15 |
| K201755 | WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody System | SeaSpine Orthopedics Corporation | MAX | Class II | 2020-12-15 |
| K202657 | Javelin Tailor's Bunion Fixation System | Nvision Biomedical Technologies, Inc. | HRS | Class II | 2020-12-14 |
| K201084 | Physica system | Lima Corporate S.P.A. | MBH | Class II | 2020-12-14 |
17,115 clearances in the Orthopedic panel. Data: openFDA.