Part 888 Subpart E—Surgical Devices
FDA submissions for Part 888 Subpart E—Surgical Devices in the Orthopedic (OR) review panel, including product codes, regulations, and recent device decisions.
Section range: §§ 888.4150–888.5980
CFR Part: 888
Product Codes
| Product Code | Device Name | Regulation | Class | Devices |
|---|---|---|---|---|
| KTZ | Caliper | 888.4150 | 1 | 7 |
| KIH | Dispenser, Cement | 888.4200 | 1 | 11 |
| OAR | Injector, Vertebroplasty (Does Not Contain Cement) | 888.4200 | 1 | 1 |
| JDZ | Mixer, Cement, For Clinical Use | 888.4210 | 1 | 13 |
| JDY | Evacuator, Vapor, Cement Monomer | 888.4220 | 1 | 8 |
| KII | Tube, Cement Ventilation | 888.4230 | 1 | 0 |
| HTJ | Gauge, Depth | 888.4300 | 1 | 4 |
| QBO | Instruments Designed For Press-Fit Osteochondral Implants | 888.4505 | 2 | 2 |
| QHG | Defect Measurement Tool | 888.4510 | 2 | 1 |
| QLQ | Manual Instruments Designed For Use With Total Disc Replacement Devices | 888.4515 | 2 | 8 |
| QLR | Manual Instruments Designed For Use With Non-Fusion Spinous Process Spacer Devices | 888.4520 | 2 | 1 |
| HRR | Scissors, Orthopedic, Surgical | 888.4540 | 1 | 8 |
| HRT | Stripper, Surgical | 888.4540 | 1 | 0 |
| HTO | Reamer | 888.4540 | 1 | 14 |
| HTP | File | 888.4540 | 1 | 5 |
| HTQ | Broach | 888.4540 | 1 | 0 |
| HTS | Knife, Orthopedic | 888.4540 | 1 | 9 |
| HTT | Burr, Orthopedic | 888.4540 | 1 | 4 |
| HTW | Bit, Drill | 888.4540 | 1 | 11 |
| HTX | Rongeur | 888.4540 | 1 | 5 |
| HWA | Impactor | 888.4540 | 1 | 4 |
| HWB | Extractor | 888.4540 | 1 | 5 |
| HWD | Starter, Bone Screw | 888.4540 | 1 | 0 |
| HWI | Corkscrew | 888.4540 | 1 | 1 |
| HWJ | Awl | 888.4540 | 1 | 4 |
| HWK | Trephine | 888.4540 | 1 | 1 |
| HWL | Set, Hollow Mill | 888.4540 | 1 | 0 |
| HWN | Instrument, Compression | 888.4540 | 1 | 4 |
| HWO | Skid, Bone | 888.4540 | 1 | 0 |
| HWP | Punch, Femoral Neck | 888.4540 | 1 | 1 |
| HWQ | Passer | 888.4540 | 1 | 9 |
| HWR | Driver, Prosthesis | 888.4540 | 1 | 4 |
| HWW | Countersink | 888.4540 | 1 | 0 |
| HWX | Tap, Bone | 888.4540 | 1 | 2 |
| HXB | Probe | 888.4540 | 1 | 15 |
| HXC | Wrench | 888.4540 | 1 | 6 |
| HXE | Fork | 888.4540 | 1 | 0 |
| HXG | Tamp | 888.4540 | 1 | 1 |
| HXI | Passer, Wire, Orthopedic | 888.4540 | 1 | 3 |
| HXJ | Staple Driver | 888.4540 | 1 | 6 |
| HXK | Holder, Needle; Orthopedic | 888.4540 | 1 | 5 |
| HXN | Applier, Cerclage | 888.4540 | 1 | 2 |
| HXO | Pusher, Socket | 888.4540 | 1 | 3 |
| HXP | Instrument, Bending Or Contouring | 888.4540 | 1 | 5 |
| HXQ | Crimper, Pin | 888.4540 | 1 | 0 |
| HXS | Twister, Wire | 888.4540 | 1 | 2 |
| HXW | Bender | 888.4540 | 1 | 3 |
| HXX | Screwdriver | 888.4540 | 1 | 4 |
| HXY | Brace, Drill | 888.4540 | 1 | 7 |
| HXZ | Cutter, Wire | 888.4540 | 1 | 1 |
| KIL | Positioner, Socket | 888.4540 | 1 | 1 |
| LXH | Orthopedic Manual Surgical Instrument | 888.4540 | 1 | 58 |
| LYQ | Accessories, Fixation, Spinal Intervertebral Body | 888.4540 | 1 | 3 |
| LYS | Bone Mill | 888.4540 | 1 | 4 |
| OCJ | Spinal Channeling Instrument, Vertebroplasty | 888.4540 | 1 | 1 |
| QWL | Intraoperative Surgical Angle Measurement Tool | 888.4560 | 2 | 3 |
| JDX | Instrument, Surgical, Sonic And Accessory/Attachment | 888.4580 | 2 | 23 |
| LZV | System, Cement Removal Extraction | 888.4580 | 2 | 7 |
| HTH | Protractor | 888.4600 | 1 | 3 |
| HWT | Template | 888.4800 | 1 | 10 |
| HST | Apparatus, Traction, Non-Powered | 888.5850 | 1 | 38 |
| HSP | Splint, Traction | 888.5890 | 1 | 1 |
| HSQ | Belt, Pelvic, Traction | 888.5890 | 1 | 1 |
| HSR | Unit, Traction, Hip, Non-Powered, Non-Penetrating | 888.5890 | 1 | 1 |
| HSS | Halter, Head, Traction | 888.5890 | 1 | 3 |
| KQZ | Component, Traction, Non-Invasive | 888.5890 | 1 | 11 |
| QZO | Wearable Vibration Device For Orthopedic Use | 888.5895 | 2 | 1 |
| LGF | Component, Cast | 888.5940 | 1 | 31 |
| LGH | Instrument, Cast Removal, Ac-Powered | 888.5960 | 1 | 9 |
| LGG | Instrument, Cast Application/Removal, Manual | 888.5980 | 1 | 3 |
Recent Devices
| Record | Device | Applicant | Decision Date |
|---|---|---|---|
| K253392 | Synergy Disc Instruments | Synergy Spine Solutions, Inc. | Mar 27, 2026 |
| K253118 | Companion Spine DIAM Instrumentation | Companion Spine France | Dec 16, 2025 |
| K252615 | Ruthless Spine RJB | Ruthless, LLC Dba Ruthless Spine | Sep 17, 2025 |
| K250554 | prodisc® L Instruments | Centinel Spine, LLC | Apr 25, 2025 |
| K242869 | prodisc® L Instruments | Centinel Spine, LLC | Dec 17, 2024 |
| K243375 | Ruthless Spine RJB | Ruthless, LLC Dba Ruthless Spine | Nov 29, 2024 |
| K241117 | M6-C Single Use, Disposable Instrumentation | Spinal Kinetics / Orthofix / Seaspine | Jun 21, 2024 |
| DEN230015 | Osteoboost Belt | Bone Health Technologies, Inc. | Jan 12, 2024 |
| DEN230012 | Ruthless Spine RJB | Ruthless, LLC Dba Ruthless Spine | Jul 14, 2023 |
| K231769 | activL® Next Generation Instrumentation | Aesculap Implants Systems, LLC | Jul 13, 2023 |
| K221848 | prodisc C SK, prodisc C Nova, and prodisc C Vivo Instruments | Centinel Spine, LLC | Aug 19, 2022 |
| K220861 | M6-C Artificial Cervical Disc Instruments AS | Spinal Kinetics, LLC | Jun 2, 2022 |
| K211757 | Simplify Disc | Nuvasive, Inc. | Aug 20, 2021 |
| K201274 | Ultrasonic Osteotomy Surgical System | Smtp Technology Co., Ltd. | Feb 19, 2021 |
| K201676 | Barricaid Instrument Tray | Intrinsic Therapeutics, Inc. | Jul 16, 2020 |
| K192873 | SX-One MicroKnife | Sonex Health, Inc. | Dec 20, 2019 |
| K192156 | Cartiva SCI instrumentation set | Cartiva, Inc. | Sep 4, 2019 |
| K181348 | Cartiva SCI Disposable Instrumentation Set | Cartiva, Inc. | Jun 20, 2018 |
| K172464 | XD880A Ultrasonic Osteotomy Surgical System | Morley Research Consortium | Apr 24, 2018 |
| K180092 | Intellitorq | Gauthier Biomedical, Inc. | Mar 8, 2018 |
| K163610 | PIEZOTOME M+, PIEZOTOME M+ Handpiece | Satalec-Acteon Group | May 19, 2017 |
| K162702 | Teeter Manual Inversion Table; Teeter Gravity Boots; Teeter Forward Rotation Decompression Device; Teeter Portable Decompression Device; Teeter Horizontal Decompression Table | Stl International, Inc. | Dec 30, 2016 |
| K153743 | PIEZOSURGERY PLUS | Mectron S.P.A. | May 25, 2016 |
| K151661 | Renovo Life Hard Carbon Coated Drill Bit | Renovo Life, LLC | Jan 15, 2016 |
| K140576 | Y WIRE 2 | Safewire, LLC | May 20, 2014 |
| K140414 | IMBIBE NEEDLE | Orthovita, Inc. | Apr 1, 2014 |
| K132848 | PIEZOSURGERY FLEX | Mectron S.P.A. | Nov 29, 2013 |
| K111437 | SYNTHES RIA SYSTEM (EXPANDED INDICATIONS) | Synthes (USA) Products, LLC | Aug 10, 2011 |
| K110858 | LO-BAK TRAX | Roland F Berthiaume, DC | Aug 2, 2011 |
| K101609 | SELF RETAINING SOFT TISSUE RETRACTOR | Koros USA, Inc. | Dec 9, 2010 |
| K100410 | PIEZOELECTRIC SYSTEM | Satelec | Apr 28, 2010 |
| K093805 | OSCAR 3 | Orthosonics, Ltd. | Feb 19, 2010 |
| K083284 | PIEZOSURGERY MEDICAL | Piezosurgery S.R.L. | Apr 8, 2009 |
| K083830 | OSCAR BONE RESECTOR | Orthosonics, Ltd. | Mar 20, 2009 |
| K072961 | LOTUS ULTRASONIC SYSTEM FOR CEMENTED IMPLANT EXTRACTION (USCIX) | Sra Developments, Ltd. | Dec 19, 2007 |
| K070293 | BENVENUE VCF OSTEO COIL SYSTEM | Benvenue Medical, Inc. | Jul 10, 2007 |
| K051820 | PARALLAX EZFLOW CEMENT DELIVERY SYSTEM | Arthrocare Corp. | Sep 6, 2005 |
| K051053 | OSCAR, MODEL OE3000DB | Orthosonics, Ltd. | Jul 21, 2005 |
| K042899 | SYNTHES (USA) RIA SYSTEM - EXPANDED INDICATIONS | Synthes (Usa) | Mar 16, 2005 |
| K043526 | SILVERSEAL TUBULAR WOUND DRESSING WITH X-STATIC | Noble Fiber Technologies, Inc. | Mar 10, 2005 |
| K042591 | SMARTMIX PRE-FILLED MIXING SYSTEM | DePuy Orthopaedics, Inc. | Oct 22, 2004 |
| K031280 | ULTRA-DRIVE 3 | Biomet, Inc. | Sep 22, 2003 |
| K024022 | OSTEO-CABLE SLEEVE | Biomet, Inc. | Jan 23, 2003 |
| K022729 | VENTED CEMENT RESTRICTOR | Amedica Corp. | Nov 14, 2002 |
| K021502 | OSCAR, MODEL OE3000 | Orthosonics, Ltd. | Jun 6, 2002 |
| K013527 | MODIFICATION TO SYNTHES (USA) REAMER IRRIGATOR ASPIRATOR (RIA) SYSTEM | Synthes (Usa) | Dec 21, 2001 |
| K002484 | EMS SWISS ORTHOCLAST CHISELS FOR NON-CEMENTED PROSTHESIS REMOVAL | Electro Medical Systems SA | Oct 4, 2000 |
| K001507 | MICROPERFORATION INSTRUMENT | Smith & Nephew, Inc. | Jun 14, 2000 |
| K993335 | SYNTHES REAMER/IRRIGATOR/ASPIRATOR (RIA) SYSTEM | Synthes (Usa) | Jun 12, 2000 |
| K984190 | BACK-ON-TRAC, MODEL 101BOT | Back-On-Track, Inc. | Mar 15, 1999 |
| K974406 | ORTHOPLAN | Ortho-Graphics, Inc. | Feb 18, 1998 |
| K973420 | CLINITEX CAST PADDING | Clinitex Medical Corp. | Dec 9, 1997 |
| K973417 | CLINITEX STOCKINETTE | Clinitex Medical Corp. | Dec 9, 1997 |
| K970360 | MITEK SUTURE RETROGRADER | Mitek Products | Mar 10, 1997 |
| K964953 | IN-TAC BONE ANCHOR SYSTEM | Influence, Inc. | Feb 13, 1997 |
| K960685 | ORTHODOC PREOPERATIVE PLANNER MODEL 500 | Integrated Surgical Systems, Inc. | Jan 17, 1997 |
| K962372 | UROTAC BONE ANCHOR INSERTER | Influence, Inc. | Aug 19, 1996 |
| K961725 | OSCAR ORTHOSONICS SYSTEM FOR CEMENTED ARTHROPLASTY REVISION | C.L. Mcintosh & Assoc., Inc. | Aug 1, 1996 |
| K960539 | DIAO HAND SURGERY SET | Kinetikos Medical, Inc. | Jul 23, 1996 |
| K961101 | STRYKER CEMENT REMOVAL SYSTEM | Stryker Corp. | Jul 15, 1996 |
| K955320 | PROTEC COTTON PADDING BANDAGE | Derivadas Degasa S.A. DE C.V. | Jan 26, 1996 |
| K952495 | ANCHORS AWAY SOFT TISSUE ATTACHMENT SYSTEM | Orthopedic Systems, Inc. | Jan 22, 1996 |
| K954915 | FLEXIBLE INTRAMEDULLARY REAMER | Zimmer, Inc. | Dec 28, 1995 |
| K943873 | ORTHOMET ANATOMICALLY GUIDED CARPAL TUNNEL RELEASE SY | Orthomet, Inc. | Apr 26, 1995 |
| K944188 | SPINAL MARKER | Leibinger L.P. | Apr 13, 1995 |
| K942906 | AGEE-WRISTJACK PRE-DRILL KIT | Hand Biomechanics Lab, Inc. | Dec 22, 1994 |
| K943906 | P.F.C. CEMENT PRESSURIZING SYSTEM | Johnson & Johnson Professionals, Inc. | Dec 21, 1994 |
| K941896 | STEADMAN LIGAMENT GRAFT PASSER AND PROTECTOR | Depuy, Inc. | Nov 7, 1994 |
| K943472 | COHORT AVB RETRACTOR SYSTEM | Cohort Medical Products Group, Inc. | Oct 20, 1994 |
| K941711 | HYPERFLEX FLEXIBLE GUIDEWIRES | Linvatec Corp. | Aug 26, 1994 |
| K941605 | STRYKER FEMORAL CANAL BRUSH, ACETABULAR BRUSH | Stryker Corp. | Aug 5, 1994 |
| K934253 | EXACTECH ALL POLY ACETABULAR CUP | Exactech, Inc. | Apr 29, 1994 |
| K940480 | ACUFEX SUB-ACROMIAL SPACE MEASURING DEVICE | Acufex Microsurgical, Inc. | Mar 23, 1994 |
| K932507 | QUICK-CAST IMMOBILIZER | Landec Corp. | Feb 23, 1994 |
| K930507 | CUSTOM ORTHOPAEDIC TRAYS (PACKS) | Associated Medical Products Co. | Feb 22, 1994 |
| K933772 | PUNCH SURGICAL | Mahe-Medizintechnik | Feb 1, 1994 |
| K933242 | SOFAMOR ORTHOPAEDIC INSTRUMENTS | Danek Medical, Inc. | Jan 28, 1994 |
| K932653 | SWISSTEK 2000(TM) CAST REMOVAL SYSTEM | Carapace, Inc. | Jan 28, 1994 |
| K934260 | BARRIER BONE WAX APPLICATOR | Phillips Pharmaceuticals, Inc. | Jan 26, 1994 |
| K933921 | ACUFLEX DISPOSABLE KNIVES | Acufex Microsurgical, Inc. | Jan 26, 1994 |
| K931733 | INTERMEDICS ORTHOPEDICS REAMERS | Intermedics Orthopedics | Jan 26, 1994 |
| K933527 | MODIFICATION OF ANTERIOR SEGMENT ELECTRODES | Mira, Inc. | Jan 25, 1994 |
| K931846 | BIO-PREP | Biomedical Devices, Inc. | Jan 21, 1994 |
| K930629 | ACRYL-X II SYSTEM | Sonokinetics, Inc. | Jan 21, 1994 |
| K925025 | PRISM BONE CEMENT MIXING SYSTEM | Depuy, Inc. | Jan 5, 1994 |
| K931672 | CARAPACE STERILE CAST PADDING | Carapace, Inc. | Dec 15, 1993 |
| K930109 | KOMET MEDICAL SURGICAL POWER ACCESORIES | Brassler USA | Aug 25, 1993 |
| K930339 | REAMER BIT | Neoligaments, Ltd. | Aug 6, 1993 |
| K930205 | ELECTRIC WIRE DRIVER, MODEL 2640E | Micro Surgical Instruments Corp. | Aug 2, 1993 |
| K932187 | PRONE POSITIONER | Voss Medical Products | Jun 1, 1993 |
| K923381 | SOFT TISSUE EXPANDER | Acufex Microsurgical, Inc. | May 5, 1993 |
| K920621 | ACUFEX PASSING PINS AND SURGICAL WIRE | Acufex Microsurgical, Inc. | May 5, 1993 |
| K930028 | CALMPS: BONE, MASTIN, LEWIN, BRAND | Thomasville Medical Assoc. | Feb 16, 1993 |
| K925335 | ACUFEX INTRA ARTICULAR MEASURING DEVICE | Acufex Microsurgical, Inc. | Dec 29, 1992 |
| K923776 | BENDEREV DRILL GUIDE | Neimark Labs, Inc. | Nov 6, 1992 |
| K921266 | NK MEDICAL MICROMETER, MODEL MC001 | Nk Biotechnical Engineering Co. | Jul 14, 1992 |
| K915776 | KNEE PROSTHESIS DRIVER | Kim-Med, Inc. | Jun 11, 1992 |
| K921402 | SURGICAL INSTRUMENT, DISPOSABLE | Macro Medical, Inc. | Jun 4, 1992 |
| K921645 | AMSEN SPINE IMPACTOR INSTRUMENTS | Advanced Med/Surg, Inc. | Jun 3, 1992 |
| K921644 | AMSEN HOCKEY STICK CHISEL | Advanced Med/Surg, Inc. | Jun 3, 1992 |
