Atlas FDA

PBF

27 FDA 510(k) clearances · Product code

224 daysmedian time to decision
446 days90th percentile
27clearances measured

FDA profile

Official device name
Orthopaedic Surgical Planning And Instrument Guides
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3030
Medical specialty
Orthopedic
FDA definition
As a surgical instrument to assist in pre-operative planning and/or guiding the marking of bone and/or guide surgical instruments for orthopedic surgical procedures.
Adverse events (MAUDE)
2022: 53 · 2023: 45 · 2024: 34 · 2025: 62
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
MedCAD® AccuStride™ System (K252064)Medcad2026-03-27
VSP Orthopedics System (K250711)3D Systems, Inc.2025-12-05
MyPAO SA guides (K242603)Medacta International S.A.2025-11-19
MedCAD® AccuStride™ System (K251709)Medcad2025-11-04
Fine TTO™ (K250394)Bodycad Laboratories, Inc.2025-10-21
Newclip Patient-matched instrumentation non sterile PSI (K250767)Newclip Technics2025-10-01
CORIOGRAPH Pre-Op Planning and Modeling Services (K250921)Blue Belt Technologies, Inc.2025-06-25
MedCAD® AccuStride™ System (K241811)Medcad2025-03-13
Newclip Patient-matched instrumentation non sterile PSI (K243912)Newclip Technics2025-02-13
Newclip Patient-matched instrumentation non sterile PSI (K240415)Newclip Technics2024-11-07
CORIOGRAPH Knee Pre-Op Plan (K240113)Smith & Nephew, Inc.2024-03-18
Fine Osteotomy™ (K240066)Bodycad Laboratories, Inc.2024-02-09
Newclip Patient-matched instrumentation non sterile PSI (K221615)Newclip Technics2023-10-25
MedCAD AccuPlan Orthopedics System (K223421)Medcad2023-09-20
Fine Osteotomy™ (K231314)Bodycad Laboratories, Inc.2023-06-02
MyPAO Guides (K220706)Medacta International S.A.2023-05-30
EmbedMed (K221943)3D Lifeprints UK , Ltd.2023-02-01
CenterMed Patient Matched Assisted Surgical Planning (ASP) System (K211614)Centermed, Inc.2022-08-04
Patient Specific Marking Guides (K211076)Additive Orthopaedics, LLC2022-06-28
RedPoint Medical's Better Bunion System (K220717)Redpoint Medical, LLC2022-06-09
3D-Cut (K212237)3D-Side S.A.2021-11-29
VSP® Orthopedics System (K211244)3D Systems2021-11-10
KLS Martin Individual Patient Solutions (IPS) Planning System (K192979)KLS-Martin L.P.2020-03-11
VSP Orthopedics System (K190044)3D Systems, Inc.2019-08-21
SurgiCase Orthopaedics, SurgiCase Connect, SurgiCase Guides (K163156)Materialise NV2017-01-18
SURGICASE ORTHOPAEDICS SYSTEM, SURGICASE CONNECT, SURGICASE GUIDES (K132290)Materialise NV2014-04-10
SURGICASE CONNECT, SURGICASE GUIDE (K112389)Materialise NV2012-07-20

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Every clearance here is in the API, with alerts when new ones post.