Part 888 Subpart B—Diagnostic Devices
FDA submissions for Part 888 Subpart B—Diagnostic Devices in the Orthopedic (OR) review panel, including product codes, regulations, and recent device decisions.
Section range: §§ 888.1100–888.1600
CFR Part: 888
Product Codes
| Product Code | Device Name | Regulation | Class | Devices |
|---|---|---|---|---|
| HRX | Arthroscope | 888.1100 | 2 | 680 |
| NBH | Accessories, Arthroscopic | 888.1100 | 1 | 2 |
| NGR | Tester, Stiffness, Cartilage, Arthroscopic | 888.1100 | 2 | 2 |
| PPR | Surgical Cannulaes & Depth Gauge Kit For Arthroscopic Procedures | 888.1100 | 2 | 0 |
| LBB | Dynamometer, Ac-Powered | 888.1240 | 2 | 36 |
| HRW | Dynamometer, Nonpowered | 888.1250 | 1 | 12 |
| KQX | Goniometer, Ac-Powered | 888.1500 | 1 | 33 |
| NKI | Goniometer With Electrodes | 888.1500 | 2 | 1 |
| KQW | Goniometer, Nonpowered | 888.1520 | 1 | 13 |
| LZE | Isometer | 888.1520 | 1 | 1 |
| QGQ | Bone Indentation Device | 888.1600 | 2 | 3 |
Recent Devices
| Record | Device | Applicant | Decision Date |
|---|---|---|---|
| K253523 | Freedom DS Decompression System | Spinal Simplicity | Apr 16, 2026 |
| K252546 | VantageTM Lumbar Decompression Kit | Allevion Medical, LLC | Mar 12, 2026 |
| K253217 | MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500); MiiS Horus Endoscope Display System -Video Box (EVS 700) | Medimaging Integrated Solution, Inc (Miis) | Dec 23, 2025 |
| K250795 | PUREVUE FMS | W.O.M. World of Medicine GmbH | Dec 5, 2025 |
| K252666 | Articulator Arthroscopic Bur | Joint Preservation Innovations, LLC | Nov 21, 2025 |
| K252458 | Kyphoplasty Balloon Dilatation Catheters | Shanghai Lange Medtech Co., Ltd. | Nov 3, 2025 |
| K252020 | TunnelVision Endoscopic Soft Tissue Release System and the HBL Blade Assembly | Hand Biomechanics Lab, Inc. | Oct 15, 2025 |
| K252594 | UltraGuideCTR® image guided soft tissue release system | Sonex Health | Sep 29, 2025 |
| K250216 | OsteoProbe (OP-100) | Active Life Scientific, Inc. | Sep 11, 2025 |
| K243774 | ELID (Endoscopic Less Invasive Decompression) System | Lesspine Innovations | Aug 27, 2025 |
| K241990 | SpineSite Endoscope System | Hydrocision, Inc. | Jul 30, 2025 |
| K243602 | Arthrex Spine Endoscope | Arthrex, Inc. | May 16, 2025 |
| K242417 | VECTR Video Endoscopic Carpal Tunnel Release System | Rafael Medical Devices, LLC | Dec 11, 2024 |
| K243020 | MIDASVu | Intravu, Inc. | Dec 2, 2024 |
| K233800 | Vertos mild Device Kit (MDK-0002) | Vertos Medical, Inc. | May 6, 2024 |
| K240535 | Digital ClarusScope System; Digital NeuroPEN System | Clarus Medical, LLC | Apr 25, 2024 |
| K233675 | FMS VUE Fluid Management and Tissue Debridement System | DePuy Mitek, Inc. | Feb 26, 2024 |
| K233115 | Hawkeye Control Unit with Eyas Endoscope | E Surgical, LLC | Feb 6, 2024 |
| K223709 | Kyphoplasty Balloon Catheter | Jiangsu Changmei Medtech Co., Ltd. | Aug 16, 2023 |
| K221142 | Kyphoplasty Balloon System | OK Medinet Korea Co., Ltd. | Apr 21, 2023 |
| K221919 | DOUBLEFLO INFLOW/OUTFLOW PUMP, accessories and tubing sets | Hemodia Sas | Mar 9, 2023 |
| K223406 | SmartRelease Endoscopic Soft Tissue Release System | Microaire Surgical Instruments | Feb 2, 2023 |
| K223244 | Pristine Arthroscopic Visualization System | Pristine Surgical | Dec 21, 2022 |
| K222490 | HBL Blade Assembly | Hand Biomechanics Lab, Inc. | Nov 14, 2022 |
| K213978 | TELIGEN System | Medos International SARL | Oct 18, 2022 |
| K221195 | OsteoProbe | Active Life Scientific, Inc. | Jun 28, 2022 |
| K212636 | CORUS Spinal System-X | Providence Medical Technology, Inc. | Oct 15, 2021 |
| K212556 | mi-eye 3 needlescope with cannula, mi-tablet 3 | Trice Medical, Inc. | Sep 15, 2021 |
| DEN210013 | OsteoProbe | Active Life Scientific, Inc. | Aug 19, 2021 |
| K211297 | SMARTRELEASE Endoscopic Soft Tissue Release System | Microaire Surgical Instruments | Jun 24, 2021 |
| K203480 | DOUBLEFLO system | Hemodia Sas | Apr 5, 2021 |
| K202027 | Balex bone Expander System | Taeyeon Medical Co., Ltd. | Feb 3, 2021 |
| K193608 | EBERLE Shaver System C3 and Accessories | Eberle GmbH & Co. KG | Jan 15, 2021 |
| K203526 | C Scope Visualization System | Cit Ortho | Jan 12, 2021 |
| K201113 | Resascope RS-01/B | Advanced Medical Systems Group Srl | Dec 21, 2020 |
| K202659 | Stryker Arthroscope | Stryker | Dec 1, 2020 |
| K192921 | Zeos Aqua Vision Pump and tube | Hemodia Sas | Oct 9, 2020 |
| K200067 | MectaScope System | Medacta International S.A. | Oct 1, 2020 |
| K200763 | Osteo-site Vertebral Balloon | Izi Medical | Aug 12, 2020 |
| K201349 | Smith+Nephew Arthroscopes | Smith & Nephew | Jul 20, 2020 |
| K200729 | HydroCision SpineJet System | Hydrocision, Inc. | Apr 16, 2020 |
| K191596 | Arcadia Balloon Catheter | Merit Medical Systems, Inc. | Oct 9, 2019 |
| K192155 | Smith & Nephew DYONICS 25 Fluid Management System | Smith & Nephew, Inc. | Sep 4, 2019 |
| K191345 | Pegasus System | A.M. Surgical, Inc. | Jul 17, 2019 |
| K191259 | Stryker CrossFlow Integrated Arthroscopy Pump | Stryker Corp. | Jul 12, 2019 |
| K191594 | Nuvis Battery Arthroscope | Integrated Endoscopy, Inc. | Jul 11, 2019 |
| K191579 | Voyant System | Viseon, Inc. | Jul 11, 2019 |
| K190804 | HydroCision TenJet Device | Hydrocision, Inc. | Jun 5, 2019 |
| K182287 | MEDINAUT Plus | Imedicom Co., Ltd. | Apr 6, 2019 |
| K190598 | CROSSWAY Spinal Access System | Globus Medical, Inc. | Apr 5, 2019 |
| K190201 | CORUS Spinal System | Providence Medical Technology, Inc. | Mar 8, 2019 |
| K183165 | Pristine Scope | Pristine Surgical | Jan 16, 2019 |
| K183470 | Precision Ideal Eyes Arthroscopes | Stryker | Jan 7, 2019 |
| K181752 | Stryker iVAS Elite Inflatable Vertebral Augmentation System (Stryker iVAS Elite Balloon Catheter) | Stryker Corporation | Dec 21, 2018 |
| K182882 | CrystalView Pro Irrigation Console, CrystalView Pro Autoclavable Remote Control | Conmed Corporation | Nov 14, 2018 |
| K181819 | SMARTRELEASE Endoscopic Soft Tissue Release System | Microaire Surgical Instruments, LLC | Nov 6, 2018 |
| K181885 | Voyant System | Viseon, Inc. | Oct 2, 2018 |
| K181982 | MIDAScope and Introducer Kit, and MIDASystem | Intravu, Inc. | Aug 21, 2018 |
| K180766 | Endiscope, Endiscope Cervical | Elliquence, LLC | Jun 11, 2018 |
| K170703 | Single Use Arthroscopic Electrode (with Pencil) | Modern Medical Equipment Manufacturing Limited | May 31, 2018 |
| K180876 | DTRAX Spinal System | Providence Medical Technology, Inc. | May 18, 2018 |
| K173311 | ARTHRO-Pump PA304 | W.O.M. World of Medicine GmbH | May 9, 2018 |
| K180315 | DISKOM | Biopsybell S.R.L. | Mar 26, 2018 |
| K172116 | Stryker iVAS Elite Inflatable Vertebral Augmentation System (Stryker iVAS Elite Balloon Catheter) | Stryker Corporation | Jan 25, 2018 |
| K171237 | FMS VUE II Fluid Management and Tissue Debridement System | Medos International SARL | Jan 18, 2018 |
| K172092 | Reprocessed Shavers/Burs | Renovo, Inc. | Oct 4, 2017 |
| K171794 | Smith & Nephew 25 Fluid Management System | Smith & Nephew, Inc. | Jun 27, 2017 |
| K162070 | JOINIX CANNULAR SYSTEM | Aju Pharm Co., Ltd. | Mar 16, 2017 |
| K162412 | Hoggan Scientific® microFET2 | Hoggan Scientific, LLC | Mar 9, 2017 |
| K163037 | Intra medullary endo-transilluminating device (iMET device) | WeMED Bio-Tech, Inc. | Feb 17, 2017 |
| K162062 | AVAmax Vertebral Balloon, AVAflex Vertebral Balloon | Stryker Corporation | Nov 1, 2016 |
| K161878 | PORTAGE System | Baylis Medical Company, Inc. | Sep 26, 2016 |
| K162475 | mi-eye 2, mi-eye 2 monitor | Trice Medical | Sep 16, 2016 |
| K152511 | Neo - Arthroscope (Rigid) 2.0mm/3.5mm, Outer sheath/ cannula, Outer sheath/ cannula w/ Handle, Trocar for outersheath/ cannula | Prosurg, Inc. | Jul 11, 2016 |
| K160249 | ULTRA Telescopes | Olympus Winter & Ibe GmbH | Apr 21, 2016 |
| K151932 | Stryker CrossFlow Day-Use Inflow Cassette Tubing and Patient-Use Tubing | Stryker Corporation | Mar 31, 2016 |
| K151268 | SPINAUT-V, SPINAUT-S, SPINAUT-I | Imedicom Co., Ltd. | Mar 16, 2016 |
| K153548 | VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM | Visionsense, Ltd. | Feb 22, 2016 |
| K151125 | AVAflex Vertebral Balloon System | Care Fusion | Nov 24, 2015 |
| K150523 | AVAmax Vertebral Balloon | Care Fusion | Oct 29, 2015 |
| K151532 | KYPHON ELEMENT Inflatable Bone Tamp | Medtronic, Inc. | Jul 23, 2015 |
| K143705 | NeedleCam HD Visualization System | Biovision Technologies, LLC | Feb 20, 2015 |
| K141557 | HERNIATOME PERCUTANEOUS DISECTOMY DEVICE - CERVICAL, HERNIATOME PERCUTANEOUS DISECTOMY DEVICE - LUMBAR | Gallini Medical Devices, Srl | Dec 8, 2014 |
| K141326 | NEEDLE VIEW CH SCOPE KITS | Biovision Technologies, LLC | Oct 8, 2014 |
| K141119 | CAMERA ENABLED PROBE | Trice Medical, Inc. | Jul 29, 2014 |
| K140903 | NUVIS ARTHROSCOPE | Integrated Endoscopy, Inc. | Jul 17, 2014 |
| K141002 | VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM | Visionsense, Ltd. | Jun 26, 2014 |
| K133682 | SCHOELLY ARTHROSCOPE | Scholly Fiberoptic GmbH | Jun 2, 2014 |
| K133941 | MITEK ARTHROSCOPES | Medos International SARL | Apr 18, 2014 |
| K130778 | DISCOSCOPES, CERVICAL ENDOSCOPES | Rz Medizintechnik GmbH | Apr 14, 2014 |
| K133018 | OSI Q SYSTEM ARTHROSCOPES | Orthopedic Sciences, Inc. | Feb 26, 2014 |
| K133061 | ESPIN SYSTEM | Nlt Spine, Ltd. | Nov 27, 2013 |
| K132883 | HEMODIA ARTHROSCOPY PUMP TUBE SETS (HATS) | Hemodia Sas | Nov 1, 2013 |
| K131820 | AVAMAX VERTEBRAL BALLOON SYSTEM, 8G, AVAMAX VERTEBRAL BALLOON SYSTEM, 10G, AVAMAX VERTEBRAL BALLOON SYSTEM, 11G | Care Fusion | Oct 4, 2013 |
| K131824 | AVAFLEX VERTEBRAL BALLOON SYSTEM | Care Fusion | Oct 3, 2013 |
| K131191 | 4MM & 5MM FULL RADIUS BLADE PLUS, 4MM & 5MM BARREL BUR PLUS/4MM BARREL TORNADO BUR PLUS, 4MM & 5MM AGGRESSIVE BLADE PLUS | Depuy Mitek, A Johnson & Johnson Company | Jul 22, 2013 |
| K130912 | OMNICUT RESECTION BLADE | Depuy Mitek, A Johnson & Johnson Company | Jun 14, 2013 |
| K130430 | IVAS 10MM AND 15MM BALLOON CATHETER | Stryker Corporation | May 23, 2013 |
| K130169 | FMS VUE FLUID MANAGMENT SYSTEM, FMS CONNECT INTERFACE CABLE | Depuy Mitek, A Johnson & Johnson Company | May 1, 2013 |
| K122411 | J-SCOPE SYSTEM | Myelotec | Feb 11, 2013 |
