Atlas FDA

HTO

14 FDA 510(k) clearances · Product code

32 daysmedian time to decision
147 days90th percentile
14clearances measured

FDA profile

Official device name
Reamer
Device class
Class I (low risk)
Regulation
21 CFR 888.4540
Medical specialty
Orthopedic
Adverse events (MAUDE)
2021: 4,802 · 2022: 3,909 · 2023: 4,401 · 2024: 4,746 · 2025: 1,056 · 2026: 578
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Sort:Newest firstOldest first

Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
SYNTHES RIA SYSTEM (EXPANDED INDICATIONS) (K111437)Synthes (USA) Products, LLC2011-08-10
SYNTHES (USA) RIA SYSTEM - EXPANDED INDICATIONS (K042899)Synthes (Usa)2005-03-16
MODIFICATION TO SYNTHES (USA) REAMER IRRIGATOR ASPIRATOR (RIA) SYSTEM (K013527)Synthes (Usa)2001-12-21
SYNTHES REAMER/IRRIGATOR/ASPIRATOR (RIA) SYSTEM (K993335)Synthes (Usa)2000-06-12
FLEXIBLE INTRAMEDULLARY REAMER (K954915)Zimmer, Inc.1995-12-28
COMBINATION REAMER (K903248)Onyx Medical Corp.1990-07-30
MCCONNELL REAMER GUIDE (K885100)Mcconnell Orthopedic1989-01-13
WARSAW ORTHOPEDIC POINTED REAMER (K870845)Warsaw Orthopedic, Inc.1987-03-11
ABC-1000 SMALL JOINT REAMERS (K862933)Instrumentation Industries, Inc.1986-08-18
MULTIPLE MANUAL SURGICAL INSTRUMENTS (K832686)Hirata Sangyo Co. USA, Inc.1983-10-14
MEDULLARY CANAL SCRAPERS (K811081)The Anspach Effort, Inc.1981-04-29
C.C.F. FEMORAL DEBRIDEMENT PROBE (K790996)Depuy, Inc.1979-06-27
FLEXIBLE REAMER, GUIDE WIRE SYSTEM (K790307)3M Company1979-02-22
HAND REAMERS (K770203)Depuy, Inc.1977-02-08

Track HTO automatically

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