Review Panel
Orthopedic FDA 510(k) Clearances & Devices
- Cleared Devices
- 17,115
- Product Codes (page)
- 37
- Latest Decision
- 2023-10-19
Clearances · page 14 of 172
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K232484 | KeyLift Expandable Interlaminar Stabilization System | Amplio Spine, LLC | PEK | Class II | 2023-10-19 |
| K232905 | Medline UNITE® REFLEX® Nitinol Staple Kit | Medline Industries, LP | JDR | Class II | 2023-10-19 |
| K231704 | Pro-Link® & Pro-Link® Ti Barbs Cervical Spacer System | Life Spine, Inc. | OVE | Class II | 2023-10-19 |
| K232371 | Actinia® hip stems | Implantcast GmbH | LZO | Class II | 2023-10-19 |
| K232123 | MectaLIF Anterior Lag Extension | Medacta International S.A. | OVD | Class II | 2023-10-18 |
| K231781 | OptiMesh Multiplanar Expandable Interbody Fusion System | Spineology, Inc. | OQB | Class II | 2023-10-18 |
| K232897 | Arthrex Small External Fixation System | Arthrex, Inc. | KTT | Class II | 2023-10-18 |
| K231899 | HAtetracell-C Titanium Cervical IBF System | Innovasis, Inc. | ODP | Class II | 2023-10-17 |
| K232878 | TransLoc 3D | Foundation Fusion Solutions, LLC (Dba Cornerloc) | OUR | Class II | 2023-10-17 |
| K231744 | VyLink Spinal Screw System | Vy Spine, LLC | NKB | Class II | 2023-10-13 |
| K232822 | Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system), Anterior cervical interbody fusion - ACIF (The Peridot-TD Anterior Cervical Intervertebral body fusion system) | Gbs Commonwealth Co., Ltd. | ODP | Class II | 2023-10-13 |
| K232481 | RIGEL 3DR Anterior Cervical Corpectomy System | MiRus, LLC | PLR | Class II | 2023-10-13 |
| K232504 | Calibrate CCX Interbody System | Alphatec Spine, Inc. | MAX | Class II | 2023-10-13 |
| K230717 | Exactech® Vantage® Total Ankle System | Exactech, Inc. | HSN | Class II | 2023-10-12 |
| K231486 | Stable-L Standalone Lumbar Interbody System | Nexus Spine, LLC | OVD | Class II | 2023-10-12 |
| K232838 | Monkey RingsTM External Fixation System | Paragon 28, Inc. | KTT | Class II | 2023-10-12 |
| K231231 | MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation Devices | Paragon 28, Inc. | HWC | Class II | 2023-10-12 |
| K230116 | Vital Spinal Fixation System | Zimvie Spine (Zimmer Biomet Spine, Inc.) | NKB | Class II | 2023-10-11 |
| K233233 | EMPHASYS Femoral Stems | Depuy Ireland UC | LZO | Class II | 2023-10-11 |
| K231658 | VEOS Spinal Fixation System | Spineway | NKB | Class II | 2023-10-10 |
| K232341 | CarboClear® Pedicle Screw System | CarboFix Orthopedics , Ltd. | NKB | Class II | 2023-10-10 |
| K232471 | Vy Spine VyLam Laminoplasty System | Vy Spine, LLC | NQW | Class II | 2023-10-10 |
| K230961 | Zeus Spinal System | Shanghai Sanyou Medical Co, Ltd. | NKB | Class II | 2023-10-10 |
| K232173 | Ascend VBR System, Ascend NanoTec VBR System | Alphatec Spine, Inc. | MQP | Class II | 2023-10-06 |
| K232411 | JuggerKnot Soft Anchor OC | Riverpoint Medical, LLC | MBI | Class II | 2023-10-06 |
| K232492 | 2.7 mm GRYPHON Flex Knotless PEEK Anchor; 2.7 mm GRYPHON Flex Knotless Biocomposite Anchor | Medos International SARL | MBI | Class II | 2023-10-06 |
| K232755 | Arthrex FiberTape and TigerTape Cerclage Sutures | Arthrex, Inc. | HTN | Class II | 2023-10-06 |
| K231078 | All-Suture Anchor | Riverpoint Medical, LLC | MBI | Class II | 2023-10-05 |
| K231716 | OsteoFlo® HydroPutty | SurGenTec, LLC | MQV | Class II | 2023-10-02 |
| K232650 | KHEIRON® Spinal Fixation System, including patient specific K-ROD | S.M.A.I.O | NKB | Class II | 2023-09-29 |
| K230591 | TriLEAP Plating System | Crossroads Extremity Systems | HRS | Class II | 2023-09-29 |
| K231649 | Intraosseous Fusion Device System | Auxano Medical, LLC | HWC | Class II | 2023-09-29 |
| K231188 | ALIGN Radial Head System | Skeletal Dynamics, Inc. | KWI | Class II | 2023-09-28 |
| K232605 | Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue® MAX + Invue Inset Anterior Cervical Plate System, and FacetFuse® Screw Fixation System | Lesspine Innovations | OUR | Class II | 2023-09-28 |
| K232668 | Cove Strip, OsteoCove Strip | SeaSpine Orthopedics Corporation | MQV | Class II | 2023-09-27 |
| K231076 | VariLift®-C Interbody Fusion System | Wenzel Spine, Inc. | ODP | Class II | 2023-09-27 |
| K230563 | EVOLUTION® Hinge Knee System | Microport Orthopedics, Inc. | KRO | Class II | 2023-09-27 |
| K232275 | Invictus® Spinal Fixation System | Alphatec Spine, Inc. | NKB | Class II | 2023-09-27 |
| K232167 | VySpan PCT System | Vy Spine, LLC | NKG | Class II | 2023-09-27 |
| K230513 | Arthrex Univers Apex OptiFit Humeral Stem | Arthrex, Inc. | KWS | Class II | 2023-09-26 |
| K232097 | IdentiTi ALIF Interbody Systems | Alphatec Spine, Inc. | OVD | Class II | 2023-09-25 |
| K231739 | Cervical Spine Truss System (CSTS) | 4Web Medical, Inc. | OVE | Class II | 2023-09-25 |
| K230857 | TiLink-P SI Joint Fusion System | SurGenTec, LLC | OUR | Class II | 2023-09-25 |
| K223933 | Exactech Equinoxe PHx Fracture System; Exactech EPIC Screws | Exactech, Inc. | HRS | Class II | 2023-09-25 |
| K231479 | TriALTIS Spine System | Medos International SARL | NKB | Class II | 2023-09-22 |
| K230067 | Para-Fix External Fixation System | New Paradigm Biomedical | LXT | Class II | 2023-09-22 |
| K230226 | Integrity-SI® Fusion System | OsteoCentric Technologies | OUR | Class II | 2023-09-21 |
| K232592 | CITRELOCK® DUO | Acuitive Technologies, Inc. | MBI | Class II | 2023-09-20 |
| K232556 | DePuy 3D Additive TriFlange Acetabular Cup and DePuy TriFlange II Acetabular Cup System | Depuy Ireland UC | LPH | Class II | 2023-09-20 |
| K223421 | MedCAD AccuPlan Orthopedics System | Medcad | PBF | Class II | 2023-09-20 |
| K230011 | Mpact Extension | Medacta International S.A. | LPH | Class II | 2023-09-20 |
| K232583 | Catalyst R1 Reverse Shoulder System | Catalyst Orthoscience, Inc. | PHX | Class II | 2023-09-20 |
| K232513 | X-Twist Biocomposite Suture Anchor | Parcus Medical | MAI | Class II | 2023-09-18 |
| K232530 | Stable-L Standalone Lumbar Interbody System, Stable-C Interbody System | Nexus Spine, LLC | OVD | Class II | 2023-09-18 |
| K230974 | NIDO Pedicle Screw System | Kalitec Medical | NKB | Class II | 2023-09-15 |
| K232315 | Catalyst Bone Void Filler | Ossdsign AB | MQV | Class II | 2023-09-15 |
| K230946 | Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression Screw System-Medium Product Code ACC-M; Accelerate Compression Screw System-Large Product Code ACC-L | Trax Surgical | HWC | Class II | 2023-09-15 |
| K223833 | Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter Trays | Exactech, Inc. | PHX | Class II | 2023-09-14 |
| K231030 | Cove Putty, OsteoCove Putty | SeaSpine Orthopedics Corporation | MQV | Class II | 2023-09-14 |
| K231147 | Hammerdesis Interphalangeal Fusion System | Intelivation | HTY | Class II | 2023-09-14 |
| K223869 | ChoiceSpine Blackhawk Ti Cervical Spacer System | Choice Spine, LLC | OVE | Class II | 2023-09-14 |
| K230750 | OSSIOfiber® Cannulated Trimmable Fixation Nail | OSSIO , Ltd. | HTY | Class II | 2023-09-13 |
| K231112 | Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner | Materialise NV | QHE | Class II | 2023-09-12 |
| K231766 | Skyway Anterior Cervical Plate System | Kyocera Medical Technologies Inc. (KMTI) | KWQ | Class II | 2023-09-12 |
| K232154 | MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate Fixation | MiRus, LLC | OVD | Class II | 2023-09-11 |
| K232002 | Vantage® Total Ankle System | Exactech, Inc. | HSN | Class II | 2023-09-11 |
| K230517 | Legends Orthopedics Suture Anchors (Legends Orthopedics 5.5 mm Suture Anchors, Legends Orthopedics 2.9 mm Suture Anchor, and Legends Orthopedics 5.5 mm Knotless Suture Anchor) | Jarmon Medical, LLC (Dba Legends Orthopedics) | MBI | Class II | 2023-09-11 |
| K231504 | TITANEX MICROBEAM Screw System, TITANEX ARTEMIS Screw System | Vilex, LLC | HWC | Class II | 2023-09-11 |
| K232457 | Q-FIX ULTRA All-Suture Anchor | Smith & Nephew | MBI | Class II | 2023-09-08 |
| K232414 | Klassic® Tibial Insert, PS-Post, Klassic All Poly Tibia, PS-Post | Total Joint Othopedics, Inc. | JWH | Class II | 2023-09-08 |
| K232426 | Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) Inserts | Conformis, Inc. | MBH | Class II | 2023-09-08 |
| K231819 | Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw | Innovate Orthopaedics Limited | HWC | Class II | 2023-09-05 |
| K231270 | Montage Flowable Settable, Resorbable Bone Paste | Orthocon, Inc. | MQV | Class II | 2023-09-01 |
| K232340 | Arthrex 2.4mm Knotless Hip SutureTak® Suture Anchor | Arthrex, Inc. | MBI | Class II | 2023-09-01 |
| K222988 | neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D Cervical | Ht Medical D.B.A. Xenix Medical | ODP | Class II | 2023-09-01 |
| K230623 | KITE Distal Fibula Kit | Intrauma S.P.A | HRS | Class II | 2023-09-01 |
| K232014 | CONDUIT ATP Inserters | Enztec Limited | MAX | Class II | 2023-09-01 |
| K230805 | TriMed Clavicle Fixation System | TriMed, Inc. | HRS | Class II | 2023-09-01 |
| K232324 | StealthFix Intraosseous Fixation System | Medartis, Inc. | JDR | Class II | 2023-08-30 |
| K231093 | AlphaVent Suture Anchors | Stryker Endoscopy | MBI | Class II | 2023-08-30 |
| K223468 | Nexis® compressive screws | Novastep | HWC | Class II | 2023-08-30 |
| K232226 | ARROW Off-Centred Humeral Insert | FH Industrie | PHX | Class II | 2023-08-29 |
| K230765 | Precice Ankle Salvage System | Nuvasive Specialized Orthopedics, Inc. | HSB | Class II | 2023-08-29 |
| K231623 | Distal Elbow Plating System | Skeletal Dynamics, Inc. | HRS | Class II | 2023-08-28 |
| K232387 | Treace Medical Concepts (TMC) Compression Implant System | Treace Medical Concepts | JDR | Class II | 2023-08-28 |
| K230094 | Responsive Arthroscopy Stealth and Mini Stealth All-Suture Anchors | Responsive Arthroscopy, LLC | MBI | Class II | 2023-08-25 |
| K231903 | Montage-QS Settable, Resorbable Bone Putty | Orthocon, Inc. | MQV | Class II | 2023-08-25 |
| K223150 | APS Metal Plate & Screw System | A Plus Biotechnology Co., Ltd. | HRS | Class II | 2023-08-24 |
| K230976 | Arthrex Radiopaque FiberTape Cerclage sutures | Arthrex, Inc. | JDQ | Class II | 2023-08-24 |
| K232218 | Zenius Spinal System | Medyssey USA, Inc. | NKB | Class II | 2023-08-24 |
| K231944 | CATAMARAN SI Joint Fusion System | Tenon Medical, Inc. | OUR | Class II | 2023-08-24 |
| K231680 | AccelFix Lumbar Expandable Cage System | L&K BIOMED Co., Ltd. | MAX | Class II | 2023-08-24 |
| K231496 | TITAN 3-D Wedge System | Paragon 28, Inc. | PLF | Class II | 2023-08-22 |
| K231811 | Zavation Connector System | Zavation Medical Products, LLC | NKB | Class II | 2023-08-22 |
| K231867 | Grappler Suture Anchor System | Paragon 28, Inc. | MBI | Class II | 2023-08-21 |
| K231266 | Pediatric Nailing Platform Tibia | OrthoPediatrics Corp. | HSB | Class II | 2023-08-21 |
| K230486 | Cove Strip | SeaSpine Orthopedics Corporation | MQV | Class II | 2023-08-21 |
| K231763 | Stable-C Interbody System | Nexus Spine, LLC | OVE | Class II | 2023-08-21 |
| K232150 | ZSFab Cervical Interbody System | Zsfab, Inc. | ODP | Class II | 2023-08-18 |
| K232144 | Sterile Products of the APTUS System | Medartis AG | HRS | Class II | 2023-08-18 |
17,115 clearances in the Orthopedic panel. Data: openFDA.