Software For Diagnosis/treatment
Orthopedic · 21 CFR 888.3030
Software associated with an orthopedic trauma device which is intended for the diagnosis or treatment of traumatic or reconstructive orthopedic conditions
Recent MDR events
22 adverse event reports on file
- MAXFRAME AUTOSTRUT(TM)HEXAPOD CRLSYS KITAug 18, 2023MalfunctionSynthes Trauma : Orthospin3015781803-2023-00027
- UPGRADE SLEEPWORKS 9.X ACQUISITION SOFTWARE WITH SPIKE / EVENT AND HIGH RES VIDEJul 7, 2023MalfunctionNatus Medical Incorporated9612330-2023-00016
- MAXFRAME AUTOSTRUT(TM)HEXAPOD STRUT-MEDJul 6, 2023MalfunctionSynthes Trauma : Orthospin3015781803-2023-00020
- MAXFRAME AUTOSTRUT(TM)HEXAPOD STRUT-MEDJul 6, 2023MalfunctionSynthes Trauma : Orthospin3015781803-2023-00021
- MAXFRAME AUTOSTRUT(TM)HEXAPOD STRUT-MEDJul 6, 2023InjurySynthes Trauma : Orthospin3015781803-2023-00023
- MAXFRAME AUTOSTRUT(TM)HEXAPOD STRUT-MEDJul 5, 2023MalfunctionSynthes Trauma : Orthospin3015781803-2023-00019
- MAXFRAME AUTOSTRUT(TM)HEXAPOD STRUT-LNGMar 13, 2023MalfunctionSynthes Trauma : Orthospin3015781803-2023-00007
- MAXFRAME AUTOSTRUT(TM)HEXAPOD CRLSYS KITMar 13, 2023MalfunctionSynthes Trauma : Orthospin3015781803-2023-00006
- SMART TSF.COMFeb 15, 2023InjurySmith & Nephew, Inc.1020279-2023-00349
- SMART TSF.COMAug 17, 2022MalfunctionSmith & Nephew, Inc.1020279-2022-03690
Event type breakdown
Recalls
2 recall events for this product code
- OrthoPediatrics CorpOpen, ClassifiedNov 22, 2022
Orthex Large Bone Shoulder Bolt, model no. AS-17
Bolt breakage on the head or threaded portion, which may cause loss of strut continuity with frame. This may cause loss of deformity correction and/or disruption of bone regeneration.
Z-0277-2023 · View FDA record ↗ - Smith & Nephew, Inc.TerminatedJan 8, 2018
Smith & Nephew Taylor Spatial Frame Website software, Catalog Number 71070401. A web-based and mobile application software component of a multilateral external
In rare circumstances, when surgeons use the software to plan the strut adjustment, an inverted image of the frame is generated by the software. The frame will appear inverted in the preview images on the Strut Settings tab.
Z-0409-2018 · View FDA record ↗
Registered firms
92 firms currently registered for this product code
Steris Schweiz Ag
Daniken Solothurn, CH
Synthes (usa) Products Llc
West Chester, PA, US
Innomedic Gmbh
Phillipsburg-Rheinsheim Baden-Wurttemberg, DE
Smith & Nephew Inc.
OKLAHOMA CITY, OK, US
Orthofix Srl
BUSSOLENGO Verona, IT
Onyx Medical Llc
MEMPHIS, TN, US
Paragon Medical Device (changzhou) Co., Ltd.
Changzhou Jiangsu, CN
Straits Orthopaedics (mfg) Sdn Bhd
Bandar Cassia Pulau Pinang, MY
Sterigenics U.s., Llc
Atlanta, GA, US
Instru-med Technologies
Warsaw, IN, US
Ionisos
Dagneux Ain, FR
Synthes Gmbh
Zuchwil Solothurn, CH
Frueh Verpackungstechnik Ag
Fehraltorf Zurich, CH
Smith & Nephew, Inc.
Memphis, TN, US
Micro Precision Swiss
Santa Ana, CA, US
Suzhou Elite Precision Machinery Co., Ltd.
Kunshan Jiangsu, CN
Arthrex, Inc.
Naples, FL, US
Smith & Nephew, Inc.
MEMPHIS, TN, US
Sterigenics Us Llc
West Memphis, AR, US
Depuy Synthes Sales
Bridgewater, MA, US
Vilex Llc
MCMINNVILLE, TN, US
510(k) clearances
4 clearances for this product code
- Disior, Ltd.Feb 26, 2026
K253764 · ENOS Software Guided External Fixation System
- Smith & Nephew, Inc.Aug 25, 2022
K221792 · Acute QC Strut and Components
- Arrowhead Medical Device Technologies, LLCAug 13, 2018
K180539 · Deformity Analysis and Correction Software (DACS) and Instrumentation
- Orthohub, Inc.Aug 25, 2014
K140550 · ORTHOHUB EXTERNAL FIXATOR SOFTWARE