Review Panel
Orthopedic FDA 510(k) Clearances & Devices
- Cleared Devices
- 17,115
- Product Codes (page)
- 37
- Latest Decision
- 2022-10-25
Clearances · page 19 of 172
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K222415 | Rexious Spinal Fixation System | Dio Medical Corporation | NKB | Class II | 2022-10-25 |
| K221545 | MectaLIF Anterior Extension | Medacta International S.A. | OVD | Class II | 2022-10-24 |
| K220190 | The GIRO Growth Modulation System | Pega Medical, Inc. | OBT | Class II | 2022-10-24 |
| K221462 | DePuy Reclaim Monobloc Revision Femoral Stem | Depuy Ireland UC | LZO | Class II | 2022-10-21 |
| K222270 | HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS Instruments | Globus Medical, Inc. | ODP | Class II | 2022-10-21 |
| K221751 | NuVasive Cohere ALIF System Intervertebral Body Fusion Device | Nu Vasive, Incorporated | OVD | Class II | 2022-10-21 |
| K222632 | UHR Bipolar Implants, Restoration GAP II Implants | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | KWL | Class II | 2022-10-21 |
| K221947 | Tyber Medical Staple Fixation System (various) | Tyber Medical, LLC | JDR | Class II | 2022-10-20 |
| K221795 | STERN FIX Sternal Stabilization System | Neos Surgery S.L | JDQ | Class II | 2022-10-19 |
| K221728 | Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System, DynaTran Anterior Cervical Plating (ACP) System, Reflex Hybrid ACP System, UniVise Spinous Process Fixation Plate | Stryker Corporation | KWQ | Class II | 2022-10-19 |
| K213978 | TELIGEN System | Medos International SARL | HRX | Class II | 2022-10-18 |
| K213123 | EVOS Wrist Spanning Plate | Smith & Nephew, Inc. | HRS | Class II | 2022-10-18 |
| K222203 | DualXSLIM(R) T/PLIF | Amplify Surgical, Inc. | MAX | Class II | 2022-10-18 |
| K222572 | FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System, and BALTEUM & BALTEUM-ONE Lumbar Plate System | Dio Medical Corporation | KWQ | Class II | 2022-10-18 |
| K221936 | Standalone ALIF Interbody Fusion System | Eminent Spine | OVD | Class II | 2022-10-17 |
| K222566 | Zimmer Persona Personalized Knee System | Zimmer, Inc. | MBH | Class II | 2022-10-17 |
| K212746 | ATTUNE Revision Cones | Depuy Ireland UC | MBH | Class II | 2022-10-17 |
| K211785 | CASSATT SIJ Fixation System | Ctl Medical Corporation | OUR | Class II | 2022-10-17 |
| K222276 | CONDUIT Cages; FIBERGRAFT BG Putty | Depuy Spine | ODP | Class II | 2022-10-15 |
| K221447 | Southern Anterior Screw Fixated Cage (SASCA) | Southern Medical (Pty) , Ltd. | OVD | Class II | 2022-10-14 |
| K221172 | FOCUS Interbody System | Oc Medical Devices | MAX | Class II | 2022-10-14 |
| K221858 | ZSFab Lumbar Interbody System | Zsfab, Inc. | MAX | Class II | 2022-10-14 |
| K222797 | X-Pac Expandable Lumbar Cage System | Expanding Innovations, Inc. | MAX | Class II | 2022-10-14 |
| K220914 | Tornier Perform Humeral System Fracture | Tornier, Inc. | PHX | Class II | 2022-10-14 |
| K222763 | Responsive Arthroscopy Mustang and Mustang Knotless Suture Anchors | Responsive Arthroscopy, LLC | MBI | Class II | 2022-10-13 |
| K222473 | EXPEDIUM® Spine System, EXPEDIUM VERSE® Spine System: ALTALYNE Ultra Rods | Medos-International Sarl | NKB | Class II | 2022-10-13 |
| K222448 | UNITY Sacroiliac Joint Fixation System | Dio Medical Corporation | OUR | Class II | 2022-10-13 |
| K222028 | IdentiTi Porous Ti Interbody System, IdentiTi NanoTec Interbody System, Transcend PEEK Interbody System, Transcend NanoTec Interbody System, IdentiTi ALIF Standalone Interbody System, IdentiTi NanoTec ALIF Standalone Interbody System | Alphatec Spine | MAX | Class II | 2022-10-07 |
| K222700 | Tibial baseplate, Tibial insert | United Orthopedic Corporation | JWH | Class II | 2022-10-06 |
| K222431 | b-ONER MOBIO Total Knee System | B-One Ortho, Corp. | JWH | Class II | 2022-10-06 |
| K222427 | PRIMA TT Glenoid | Lima Corporate S.P.A. | MBF | Class II | 2022-10-06 |
| K211892 | ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages) | Arftx Medical, LLC | MQP | Class II | 2022-10-06 |
| K221128 | Arthrex ACL TightRope®, PCL TightRope®, and TightRope® II | Arthrex, Inc. | MAI | Class II | 2022-10-05 |
| K221646 | CD HORIZON ASTUTE SPINAL SYSTEM; CD HORIZON Growth Rod Conversion Set; CD HORIZON SPINAL SYSTEM; CD Horizon Fenestrated Screw Set; COLORADO 2 SPINAL System; GDLH POSTERIOR SPINAL SYSTEM; SHILLA Growth Guidance System; TENOR SPINAL SYSTEM | Medtronic Sofamor Danek USA, Inc. | NKB | Class II | 2022-10-04 |
| K222380 | TriVerse Total Knee Replacement System | Signature Orthopaedics Pty, Ltd. | JWH | Class II | 2022-10-04 |
| K213842 | ONVOY Acetabular System | Globus Medical, Inc. | LPH | Class II | 2022-10-03 |
| K221047 | SILO TFX MIS Sacroiliac Joint Fixation System | Aurora Spine, Inc. | OUR | Class II | 2022-10-03 |
| K222267 | Arthrex 2.4 mm Volar Distal Radius Plate System | Arthrex, Inc. | HRS | Class II | 2022-10-03 |
| K213014 | Varixis Elbow System | Auxein Medical Private Limited | HRS | Class II | 2022-10-03 |
| K222244 | Arthrex 3.5 mm Locking Compression Plates | Arthrex, Inc. | HRS | Class II | 2022-09-30 |
| K220336 | Mg-PSZ Ceramic Femoral Head | Theken Companies | LPH | Class II | 2022-09-30 |
| K213417 | Ghost Spacer System | Life Spine, Inc. | MAX | Class II | 2022-09-29 |
| K213126 | Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP Mini-Mod, Compression Hip Screw (CHS), CONQUEST FN, and cannulated screws | Smith & Nephew, Inc. | JDO | Class II | 2022-09-29 |
| K222605 | iFuse TORQ® Implant System | SI-BONE, Inc. | OUR | Class II | 2022-09-29 |
| K222482 | AGILON XO Shoulder System | Implantcast GmbH | KWT | Class II | 2022-09-28 |
| K221360 | Medline UNITE® Medial Malleolus Peg Plate System | Medline Industries, LP | HRS | Class II | 2022-09-27 |
| K220483 | Platform® Acetabular System | Total Joint Orthopedics, Inc. | LZO | Class II | 2022-09-23 |
| K222561 | Align | Acuity Surgical Devices, LLC | OVD | Class II | 2022-09-23 |
| K212197 | WasherCap Fixation System | Abanza Tecnomed S.L | MBI | Class II | 2022-09-22 |
| K221809 | DePuy Synthes 3.5mm Intrapelvic Acetabular System | DePuy Synthes | HRS | Class II | 2022-09-20 |
| K220359 | Tandry Compression Screw System | Microware Precision Co., Ltd. | HWC | Class II | 2022-09-20 |
| K220839 | Arthrex Compression FT Pins | Arthrex, Inc. | HWC | Class II | 2022-09-19 |
| K220441 | CYGNUS MoRe Anterior Cervical Plate System | MiRus, LLC | KWQ | Class II | 2022-09-16 |
| K211027 | Altus Spine Pedicle Screw System | Altus Partners, LLC | NKB | Class II | 2022-09-16 |
| K220297 | True Tulip, True M.I.S. | Innovative Surgical Designs, Inc. | NKB | Class II | 2022-09-16 |
| K213856 | Identity Shoulder System | Zimmer, Inc. | MBF | Class II | 2022-09-15 |
| K213641 | MONDRIAN ALIF Cage with Supplementary Fixation Plate | Ctl Medical Corporation | MAX | Class II | 2022-09-15 |
| K221968 | StageOne Shoulder Cement Spacer Molds | Biomet, Inc. | MBB | Class II | 2022-09-15 |
| K222091 | Grappler Suture Anchor System | Paragon 28, Inc. | MBI | Class II | 2022-09-14 |
| K220418 | Tornier Perform Humeral System Stemless | Tornier, Inc. | PKC | Class II | 2022-09-14 |
| K213770 | SP-CL Hip Stem and LCU Hip System | Waldemar Link GmbH & Co. KG | LZO | Class II | 2022-09-13 |
| K220953 | ChoiceSpine TigerShark M, Modular Interbody System | Choice Spine, LLC | MAX | Class II | 2022-09-13 |
| K222512 | Integrity-SI Fusion System | OsteoCentric Technologies | OUR | Class II | 2022-09-12 |
| K220659 | AUTOBAHN(R) EVO Femoral Nails | Globus Medical, Inc. | HSB | Class II | 2022-09-09 |
| K221388 | NuVasive Reline Cervical System | Nu Vasive, Incorporated | NKG | Class II | 2022-09-09 |
| K222409 | CAPTIVATE® Compression Screws | Globus Medical, Inc. | HWC | Class II | 2022-09-08 |
| K221731 | FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch Implant, Straight with two Polyester Implants and 2-0 FiberWire | T.A.G. Medical Products Corporation, Ltd. | MBI | Class II | 2022-09-07 |
| K222110 | Mariner RDX System | SeaSpine Orthopedics Corporation | NKB | Class II | 2022-09-07 |
| K221283 | Hammertoe Truss System (HTS) | 4Web Medical, Inc. | HTY | Class II | 2022-09-06 |
| K221636 | EMPHASYS Acetabular System | Depuy Ireland UC | LPH | Class II | 2022-09-06 |
| K213287 | StageOne Knee Cement Spacer Molds | Biomet, Inc. | MBB | Class II | 2022-09-02 |
| K213864 | Bonebridge Osteosynthesis Plating System | Bonebridge AG | HRS | Class II | 2022-09-02 |
| K203503 | Camber Sacroiliac (SI) Fixation System | Camber Spine Technologies, LLC | OUR | Class II | 2022-09-02 |
| K221644 | Synthetic Bone Putty | Ventris Medical | MQV | Class II | 2022-09-02 |
| K221745 | Sterile Posterior Spinal Fixation System | Shanghai Reach Medical Instrument Co, Ltd. | NKB | Class II | 2022-08-31 |
| K210935 | I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix) | I.T.S. GmbH | HRS | Class II | 2022-08-31 |
| K221467 | INHANCETM Reverse Glenoid Peripheral Posts | Depuy Ireland UC | PHX | Class II | 2022-08-31 |
| K222362 | Salvo® Spine System | Spine Wave, Inc. | NKB | Class II | 2022-08-29 |
| K220875 | HAcancellous PEEK-C Porous HA PEEK Cervical IBF System | Innovasis, Inc. | ODP | Class II | 2022-08-26 |
| K222263 | Arthrex Self Punching SwiveLock Suture Anchors | Arthrex, Inc. | MAI | Class II | 2022-08-26 |
| K222256 | BonOs® Inject Bone Cement; NEO Pedicle Screw System | Neo Medical SA | PML | Class II | 2022-08-26 |
| K222278 | LOSPA TKR System Instrumentation, EXULT TKR System Instrumentation | Corentec Co., Ltd. | JWH | Class II | 2022-08-26 |
| K221792 | Acute QC Strut and Components | Smith & Nephew, Inc. | OSN | Class II | 2022-08-25 |
| K221325 | CONDUIT Lateral Switch Plate | Medos International SARL | MAX | Class II | 2022-08-25 |
| K213905 | ONX Large External Fixation System | Orthonovis, Inc. | KTT | Class II | 2022-08-25 |
| K221920 | ARIX Small Fragment System | Jeil Medical Corporation | HRS | Class II | 2022-08-24 |
| K213803 | FIBERGRAFT Aeridyan Matrix Bone Graft Substitute | Prosidyan, Inc. | MQV | Class II | 2022-08-23 |
| K221850 | GMK 3D Metal Tibial Tray | Medacta International S.A. | MBH | Class II | 2022-08-23 |
| K221485 | Arthrex FiberTape and TigerTape Cerclage Sutures | Arthrex, Inc. | HTN | Class II | 2022-08-22 |
| K213109 | Auxilock Draw Tight Suture-Based Anchor | Auxein Medical Private Limited | MBI | Class II | 2022-08-22 |
| K221848 | prodisc C SK, prodisc C Nova, and prodisc C Vivo Instruments | Centinel Spine, LLC | QLQ | Class II | 2022-08-19 |
| K220812 | DynaClip® Bone Staple | MedShape, Inc. | JDR | Class II | 2022-08-19 |
| K220696 | uCerv Flux-C 3D Porous Titanium Cervical Interbody | Ulrich Medical USA | ODP | Class II | 2022-08-19 |
| K221403 | Cortera Spinal Fixation System | Surgalign Spine Technologies | NKB | Class II | 2022-08-19 |
| K221023 | Posterior Fusion Plate/HA Posterior Fusion Plate (Minuteman G1), Minuteman G3/HA Minuteman G3, HA Minuteman G3-R, Minuteman G5 | Spinal Simplicity, LLC | PEK | Class II | 2022-08-19 |
| K222194 | Baby Gorilla®/Gorilla® Plating System | Paragon 28, Inc. | HRS | Class II | 2022-08-19 |
| K220959 | OR3O Dual Mobility System | Smith & Nephew, Inc. | LPH | Class II | 2022-08-18 |
| K210678 | implaFit® hip stems | Implantcast GmbH | LZO | Class II | 2022-08-17 |
| K220452 | Materialise Shoulder SystemTM Materialise Shoulder Guide and Models SurgiCase Shoulder Planner | Materialise NV | QHE | Class II | 2022-08-17 |
| K221844 | TDM Lumbar Interbody Fusion Cage System | Tdm Co., Ltd. | MAX | Class II | 2022-08-17 |
17,115 clearances in the Orthopedic panel. Data: openFDA.