Review Panel
Orthopedic FDA 510(k) Clearances & Devices
- Cleared Devices
- 17,115
- Product Codes (page)
- 34
- Latest Decision
- 2023-06-09
Clearances · page 16 of 172
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K231037 | MyKnee UNI-ST | Medacta International S.A. | JWH | Class II | 2023-06-09 |
| K222684 | XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato® Spinal System, XIA® Growth Rod Conversion Set, XIA® II Spinal System, XIA® Precision System, XIA® Anterior, Diapason® Spinal System, Opus Spinal System, Radius® Spinal System, Mantis® Spinal System, Mantis® Redux, Trio® & Trio+ Spinal Fixation System, ES2 Spinal System, ES2 Augmentable Spinal System, Oasys® Occipito-Cervico-Thoracic System, Nile® Proximal Fixation Spinal System, Nile® Alternative Fi | Stryker Spine | NKB | Class II | 2023-06-08 |
| K230572 | AETOS Shoulder System | Smith & Nephew, Inc. | KWS | Class II | 2023-06-07 |
| K231322 | Fix2Lock(PEEK Self Punching) | Osteonic Co., Ltd. | MBI | Class II | 2023-06-07 |
| K223059 | Xenco Medical InterAlign Cervical Interbody System | Xenco Medical, LLC | OVE | Class II | 2023-06-07 |
| K231002 | Javelot PK-S suture anchor, Javelot PK-S suture anchor (Knotless), Javelot PK-P suture anchor, Javelot PK-P suture anchor (Knotless), Javelot PK-L suture anchor (Knotless) | Suzhou Endophix Co., Ltd. | MBI | Class II | 2023-06-07 |
| K230446 | TiLink-L SI Joint Fusion System | SurGenTec, LLC | OUR | Class II | 2023-06-07 |
| K230329 | F3D Interbody System | Corelink, LLC | ODP | Class II | 2023-06-06 |
| K223801 | FX V135(TM) Shoulder Prosthesis | Fx Shoulder USA, Inc. | PHX | Class II | 2023-06-05 |
| K230971 | APTUS® 3.5 TriLock Straight Plates | Medartis AG | HRS | Class II | 2023-06-02 |
| K231314 | Fine Osteotomy | Bodycad Laboratories, Inc. | PBF | Class II | 2023-06-02 |
| K230952 | Triathlon® Total Knee System - Triathlon® Pro Posterior Stabilized (PS) Femoral Component | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | JWH | Class II | 2023-06-02 |
| K230936 | Anatomic PEEK Cervical Fusion System with Nanotechnology | Nanovis, LLC | ODP | Class II | 2023-06-02 |
| K231330 | FiberTak® Suture Anchor | Arthrex, Inc. | MBI | Class II | 2023-06-01 |
| K231326 | Fix2Lock(Biocomposite medial, lateral, Biocombi Self Punching) | Osteonic Co., Ltd. | MAI | Class II | 2023-05-31 |
| K223762 | Smith & Nephew ACCORD Cable System | Smith & Nephew | HRS | Class II | 2023-05-30 |
| K220706 | MyPAO Guides | Medacta International S.A. | PBF | Class II | 2023-05-30 |
| K223096 | Dark Star Deformity Pedicle Screw System | Republic Spine, LLC | NKB | Class II | 2023-05-26 |
| K230851 | Kodiak Lumbar Spacer System | Met One Technologies, LLC | MAX | Class II | 2023-05-26 |
| K231233 | Identity Imprint CR KRS and Identity Imprint PS KRS | Conformis, Inc. | JWH | Class II | 2023-05-26 |
| K222624 | KLS Martin LINOS Wrist System | KLS-Martin L.P. | HRS | Class II | 2023-05-25 |
| K222229 | Advanced LumFix Spinal Fixation System | CG Bio Co., Ltd. | NKB | Class II | 2023-05-25 |
| K231178 | ACTERA hip system | Conformis, Inc. | MEH | Class II | 2023-05-23 |
| K230874 | Syntheface PEEK Interference Screw, Syntheface PEEK Screw Sheath | Suzhou Endophix Co., Ltd. | MBI | Class II | 2023-05-23 |
| K223860 | Integrity Bone Staple Fixation System | Anika Therapeutics, Inc. | MBI | Class II | 2023-05-22 |
| K230708 | 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 | 2023-05-22 |
| K222833 | Ventana C Spinal System | Spinal Elements, Inc. | ODP | Class II | 2023-05-19 |
| K231140 | aprevo® transforaminal lumbar interbody fusion device | Carlsmed, Inc. | MAX | Class II | 2023-05-19 |
| K230537 | Klassic Knee Revision System | Total Joint Othopedics, Inc. | JWH | Class II | 2023-05-19 |
| K230416 | Triathlon® Hinge Knee System; Triathlon® Revision Insert X3® | Stryker | KRO | Class II | 2023-05-19 |
| K221323 | Exactech® Alteon® Short Tapered Wedge | Exactech, Inc. | LZO | Class II | 2023-05-19 |
| K231113 | Arthrex FiberTak Suture Anchor | Arthrex, Inc. | MBI | Class II | 2023-05-18 |
| K231128 | JuggerKnot Soft Anchor | Riverpoint Medical, LLC | MBI | Class II | 2023-05-17 |
| K230219 | Eminent Spine 3D Lumbar Interbody Fusion Systems | Eminent Spine, LLC | MAX | Class II | 2023-05-16 |
| K230414 | ClariVy Cervical IBF System | Vy Spine, LLC | ODP | Class II | 2023-05-12 |
| K230394 | EUROSCREW NG; EUROSCREW TCP NG | Teknimed | MAI | Class II | 2023-05-12 |
| K230550 | JAWS Nitinol Staple System | Paragon 28, Inc. | JDR | Class II | 2023-05-11 |
| K223318 | Internal Joint Stabilizer - Elbow | Skeletal Dynamics, Inc. | OZI | Class II | 2023-05-10 |
| K223655 | Catalyst R1 Reverse Shoulder System | Catalyst Orthoscience, Inc. | PHX | Class II | 2023-05-09 |
| K230721 | ATEC Lateral Plate System | Alphatec Spine, Inc. | KWQ | Class II | 2023-05-09 |
| K223335 | SIRION Lateral Lumbar Interbody System | Astura Medical | MAX | Class II | 2023-05-09 |
| K222436 | Latitud Hip Replacement System | Meril Healthcare Pvt. , Ltd. | LPH | Class II | 2023-05-09 |
| K230653 | Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and II Knee Systems, JOURNEY II CR Knee System, JOURNEY II Uni Knee System, Journey II UK Knee System, JOURNEY II XR Bi-Cruciate Retaining Knee System, JOURNEY PFJ System, JOURNEY Uni Knee System, Legion Hinge Total Knee System, Legion Total Knee System, ZUK Unicompartmental Knee System, ENGAGE Partial Knee System and Porous Patella and Porous Tibial Baseplates | Smith & Nephew, Inc. | JWH | Class II | 2023-05-04 |
| K222097 | OLYMPIC Deformity Band System | Astura Medical | OWI | Class II | 2023-05-04 |
| K223430 | ProLift Micro Expandable Spacer System | Life Spine, Inc. | MAX | Class II | 2023-05-04 |
| K230655 | PEEK RCI Screw; Bio-Composite Screw; SignaLoc Screw | Signature Orthopaedics Pty, Ltd. | MBI | Class II | 2023-05-03 |
| K230123 | Apollo Knotless Suture Anchor | Maruho Medical | MBI | Class II | 2023-05-03 |
| K230938 | ARIX Humerus System | Jeil Medical Corporation | HRS | Class II | 2023-05-03 |
| K230614 | Cortium | Ulrich Medical USA | NKG | Class II | 2023-05-02 |
| K223529 | PressON Spinal Fixation System | Nexus Spine, LLC | NKB | Class II | 2023-05-02 |
| K230908 | Hand Trauma Threaded Nail System | Skeletal Dynamics, Inc. | HWC | Class II | 2023-04-28 |
| K222004 | INTEGRATE -C Interbody Fusion System | Happe Spine | ODP | Class II | 2023-04-28 |
| K222381 | PeriPRO Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating System | Stryker GmbH | HRS | Class II | 2023-04-27 |
| K230844 | Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) Insert | Conformis, Inc. | JWH | Class II | 2023-04-27 |
| K223868 | PYXIS 3D Titanium Cage System | GS Medical Co., Ltd. | MAX | Class II | 2023-04-26 |
| K230204 | ALPHALOK Plating System | Vilex, LLC | HRS | Class II | 2023-04-25 |
| K220513 | NITRO Interbody Fusion Cage System Family | Ctl Medical Corporation | ODP | Class II | 2023-04-25 |
| K220261 | NEST-C Interbody System | Paonan Biotech Co., Ltd. | ODP | Class II | 2023-04-24 |
| K220274 | Kisar Stratford SI Screw System | Anjali Investments L.L.C | OUR | Class II | 2023-04-24 |
| K221142 | Kyphoplasty Balloon System | OK Medinet Korea Co., Ltd. | HRX | Class II | 2023-04-21 |
| K230808 | PEEK SA Anterior Lumbar Interbody Fusion (ALIF) System | Kyocera Medical Technologies, Inc. | OVD | Class II | 2023-04-21 |
| K223069 | Modular Rotating Hinge Knee Systems and Compatible Components | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | KRO | Class II | 2023-04-21 |
| K230565 | HILINE Fixation System | Globus Medical, Inc. | OWI | Class II | 2023-04-20 |
| K212220 | ArtFX Spinal Fixation System | Artfx Medical, LLC | NKB | Class II | 2023-04-20 |
| K221220 | Montross Extremity Medical Hemi Implant System | Montross Extremity Medical | KWD | Class II | 2023-04-19 |
| K230053 | SimpliFix Hip System | Stabiliz Orthopaedics, Inc. | HWC | Class II | 2023-04-19 |
| K230766 | Altus Spine Monaco Pedicle Screw System | Altus Spine | NKB | Class II | 2023-04-19 |
| K230764 | OsteoCentric Integrated Hip Fastener System | OsteoCentric Technologies | JDO | Class II | 2023-04-18 |
| K223513 | UniVy OsteoVy-Ti Cervical IBF System | Vy Spine, LLC | ODP | Class II | 2023-04-18 |
| K230544 | SnugFit All-Suture Anchor extension | Medacta International S.A. | MBI | Class II | 2023-04-17 |
| K230749 | TriMed Threaded Intramedullary Nail System | TriMed, Inc. | HWC | Class II | 2023-04-17 |
| K222066 | LINK MobileLink Acetabular Cup System | Waldemar Link GmbH & Co. KG | LPH | Class II | 2023-04-14 |
| K230424 | Omnia Medical Coupler-A Anterior Lumbar Plate System; Omnia Medical Coupler-L Lateral Lumbar Plate System | Omnia Medical, LLC | KWQ | Class II | 2023-04-12 |
| DEN220033 | MISHA Knee System | Moximed, Inc. | QVV | Class II | 2023-04-10 |
| K230366 | Arthrex Univers Revers Monoblock Stem Size 4/33 | Arthrex, Inc. | PHX | Class II | 2023-04-10 |
| K223772 | PRO Plating System, Stryker Trauma Pelvic Set (Matta) | Stryker GmbH | HRS | Class II | 2023-04-07 |
| K230313 | QUANTUM Patient Specific Instrumentation (PSI) System | In2bones Sas | HSN | Class II | 2023-04-06 |
| K230169 | EMPOWR Revision VVC+ (Varus / Valgus Constrained), e+ Tibial Insert | Encore Medical, L.P Dba Enovis | JWH | Class II | 2023-04-06 |
| K230689 | T-FIX 3DSI Joint Fusion System | Cutting Edge Spine, LLC | OUR | Class II | 2023-04-05 |
| K220142 | BRM Digitalis Spacer | Brm Extremities Srl | KYJ | Class II | 2023-04-04 |
| K230568 | FiberTak Suture Anchor | Arthrex, Inc. | MBI | Class II | 2023-04-01 |
| K223326 | Axiom PSR System | Restor3D | OYK | Class II | 2023-03-30 |
| K221324 | ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF) | Camber Spine Technologies | OVD | Class II | 2023-03-30 |
| K230555 | Cemented Tibia Baseplate no Taper with JRNY Lock | Smith & Nephew, Inc. | JWH | Class II | 2023-03-30 |
| K223342 | MotoBAND CP Implant System: DynaBunion 4D Minimal-incision Bunion System, DynaMET Lesser TMT Fusion System | Crossroads Extremity Systems, LLC | HRS | Class II | 2023-03-30 |
| K223853 | Medartis APTUS® Ulna Plates | Medartis AG | HRS | Class II | 2023-03-30 |
| DEN220030 | RemeOs Screw LAG Solid | Bioretec, Ltd. | QJD | Class II | 2023-03-29 |
| K222397 | KLS Martin Level One Rib Fixation System | KLS-Martin L.P. | HRS | Class II | 2023-03-29 |
| K223915 | Tactoset | Anika Therapeutics, Inc. | MQV | Class II | 2023-03-29 |
| K213815 | SiJoin®T3 | Vgi Medical, Inc. | OUR | Class II | 2023-03-29 |
| K223611 | Calibrate LTX Interbody System | Alphatec Spine, Inc. | MAX | Class II | 2023-03-29 |
| K230527 | WishBone Medical Plate and Screw System | Wishbone Medical, Inc. | HRS | Class II | 2023-03-29 |
| K230026 | SQUALE | Implanet, S.A. | ODP | Class II | 2023-03-28 |
| K221938 | KLS Martin Pure Pectus System | KLS Martin L.P. | HRS | Class II | 2023-03-28 |
| K223803 | Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) System | Canary Medical USA, LLC | QPP | Class II | 2023-03-24 |
| K230482 | Swedge Pedicle Screw Fixation System | Spinal Resources, Inc. | NKB | Class II | 2023-03-23 |
| K222423 | Fixone All Suture Anchor | Aju Pharm Co., Ltd. | MBI | Class II | 2023-03-23 |
| K222105 | RESPONSE 5.5/6.0 Cannulated Screw System | OrthoPediatrics Corp. | NKB | Class II | 2023-03-23 |
| K223441 | SpaceFlex Acetabular Cup | G21, S.R.L. | KWY | Class II | 2023-03-23 |
| K230583 | Tryptik Ti | Spineart SA | ODP | Class II | 2023-03-22 |
17,115 clearances in the Orthopedic panel. Data: openFDA.