Atlas FDA

HWE

76 FDA 510(k) clearances · Product code

76 daysmedian time to decision
269 days90th percentile
76clearances measured

FDA profile

Official device name
Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
Device class
Class I (low risk)
Regulation
21 CFR 878.4820
Medical specialty
General, Plastic Surgery
Adverse events (MAUDE)
2021: 3,140 · 2022: 3,327 · 2023: 3,397 · 2024: 3,686 · 2025: 2,882 · 2026: 1,448
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
IntelliSense Drill (K143191)Mcginley Innovations2015-02-20
ORTHO SOLUTIONS - STERILE, DRILLS, TAPS, GUIDE PINS & WIRES (K102743)Ortho Solutions Limited2011-01-20
SURGICAL IRRIGATION SYSTEM, IRRIGATION TUBE (K063688)The Anspach Effort, Inc.2007-01-16
EXPLANT OSTEONECROSIS INTERVENTION IMPLANT REMOVAL SYSTEM (K050766)Zimmer Trabecular2005-05-26
SYNTHES (USA) ELECTRIC PEN DRIVE SYSTEM (K043310)Synthes (Usa)2005-01-05
REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURS (K022744)Medical Device Services2002-09-18
REPROCESSED USED, DISPOSABLE BLADES, BURS, BITS AND TAPS (K012676)Adven Medical2002-02-04
REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURS (K012694)Adven Medical2002-02-04
AVCORE SYSTEM (K990816)Modular Cutting Systems, Inc.1999-09-24
AESCULAP HILAN MOTOR SYSTEM (K973736)Aesculap, Inc.1997-12-29
BONE GRAFT HARVESTER (K973560)Ds Mfg., Inc.1997-11-12
SURGICAL BURS AND SURGICAL DRILL BITS (K972508)Synvasive Technology, Inc.1997-08-26
DISK WHISK CUTTING DEVICE (CONICAL, ELLIPTICAL AND BALL HEAD) (K971342)Disk Whisk, Inc.1997-07-08
SYNTHES (USA) COMPACT AIR DRIVE II (CAD II) (K971544)Synthes (Usa)1997-05-28
SERVOTRONIC EC100 SYSTEM (K962087)Medicon, Inc.1997-04-23
RIWO DRIVE WITH FOOTSWITCH/MOTOR HANDLE, COOMPLETE,6000RPM/3000RPM/ROTARY BLADES AND ABRADERS SEE SECTION 1: (K970088)Richard Wolf Medical Instruments Corp.1997-04-07
SPINE-TECH BONE HARVESTER (K970040)Spine-Tech, Inc.1997-02-28
MEDNEXT SURGICAL BUR (K970023)Mednext, Inc.1997-02-28
SYNTHES STERILE DRILL BITS (K962913)Synthes (Usa)1996-11-14
STRYKER UNIVERSAL DRILL ATTACHMENTS & ACCESSORIES (K962800)Stryker Instruments1996-09-11
CONSENSUS POSTERIOR STABILIZED KNEE-INTERCONDYLAR NOTCH ROUTER (K962215)U.S. Medical Products, Inc.1996-08-15
POWERCUT GOLD SURGICAL SYSTEM (K962022)Baxter Healthcare Corp1996-08-05
COMMAND 2 MICOELECTRIC SURGICAL SYSTEM (K961970)Stryker Corp.1996-07-26
CEMENT AND BONE REMOVAL KIT (K961759)Maillefer Instruments S.A.1996-06-13
EXACTECH STERILE MODULAR DRILL BIT (K960720)Exactech, Inc.1996-04-23
HALL MODULAR ACETABULAR REAMER SYSTEM (K960852)Linvatec Corp.1996-03-20
AESCULAP POWER SYSTEMS (ELAN-E & MICROTRON) (K953968)Aesculap, Inc.1996-02-05
3M MINI-DRIVER ELECTRIC SYSTEM (K955098)3M Company1996-01-22
MICROAIRE SMARTDRIVE SYSTEM (K955591)Microaire Surgical Instruments, Inc.1996-01-18
GRAFTOLOGER PGH & ACL RECONSTRUCTION INSTRUMENT SET (K952543)Neoligaments, Ltd.1995-06-22
CONSENSUS(TM) ORTHOPEDIC DRILL BIT (K950013)U.S. Medical Products, Inc.1995-05-05
CONSENSUS(TM) PATELLA REAMER (K946197)U.S. Medical Products, Inc.1995-04-05
CONSENUS HIP SYSTEM FEMORAL CANAL STARTER REAMER (K944946)U.S. Medical Products, Inc.1995-02-01
CONSENUS HIP SYSTEM -- ACETABULAR REAMER (K945186)U.S. Medical Products, Inc.1995-01-27
CONSENSUS HIP SYSTEM -- CALCAR PLANER (K945189)U.S. Medical Products, Inc.1995-01-27
CONSENSUS HIP SYSTEM -- TROCHANTERIC CUTTER (K945208)U.S. Medical Products, Inc.1995-01-27
STRYKER TOTAL PERFORMANCE SYSTEM (K943589)Stryker Corp.1994-12-15
COHORT BONE BRUSH (K942108)Advanced Med/Surg, Inc.1994-10-11
SURGICAL INSTRUMENTS AND ACCESSORIES (K942956)Stryker Corp.1994-09-23
HALL MICROCHOICE ELECTRIC POWERED SYSTEM (K942660)Hall Surgical, Division of Zimmer, Inc.1994-09-07
TOTAL KNEE KIT (K932918)Biodynamic Technologies, Inc.1994-09-01
COOL CUT (K931429)Mitab1994-04-29
THE GRAFTOLOGER (K935753)Neoligaments, Ltd.1994-04-25
INTERMEDICS ORTHOPEDICS DRILL BITS (K931734)Intermedics Orthopedics1994-02-22
SNAP BONE REAMER (K935322)Surgiquip, Inc.1994-01-28
SNAP DRILL (K935516)Surgiquip, Inc.1994-01-27
BONE SAW BLADES (K931176)Betzler Mfg., Inc.1994-01-26
ARTHREX AR-8200 SHAVER SYSTEM (K932699)Arthrex, Inc.1994-01-25
SODEM POWER SYSTEM (K935567)Sodemsystems1994-01-21
OSTEON ADAPTOR/CRADLE (K930319)United American Medical Co., Inc.1994-01-07
ACUFEX STERILE DRILLS (K931837)Acufex Microsurgical, Inc.1994-01-07
ES-100 ACCESSORIES (K932261)Elekta Instruments, Inc.1994-01-07
POWERED SURGICAL INSTRUMENT ACCESSORY (K930363)Intenn Engineering, Inc.1994-01-07
HHI ELECTRIC CONSOLE #875-000 (K922056)H&H Instruments1992-09-18
CKS OSCILLATING SAW BLADE (K921131)Techmedica, Inc.1992-06-08
STERILE PACKAGED POWER INSTRUMENT ACCESSORIES (K911930)United American Medical Co., Inc.1991-07-02
SMALL BONE FIXATION SYSTEM (K911929)United American Medical Co., Inc.1991-07-02
ACE/WILLIAMS MICROSURGERY SAW SYSTEM (K902525)Buckman Co., Inc.1990-11-26
OSCILLATING SAW BLADES # SO-305,MO-305 AND ZO-305 (K903650)Micro-Aire Surgical Instruments, Inc.1990-09-14
CORING NEEDLE (TREPHINE, ORTHOPEDIC) (K902447)Biomedtrix, Ltd.1990-08-14
HALL MODULAR ACETABULAR REAMER SYSTEM (K902332)Zimmer, Inc.1990-06-25
MODULAR FLEXIBLE DRILLING SYSTEM (K901165)Dalton Technology, Inc.1990-06-13
HALL VERSIPOWER SURGICAL INSTRUMENT SYSTEM (K895198)Zimmer, Inc.1989-09-15
ACE SCREW REMOVAL TREPHINE (K882008)Buckman Co., Inc.1988-06-10
PACESETTER (TM) 3500 ARTHROSCOPIC SURGICAL SYSTEM (K880150)Dyonics, Inc.1988-03-04
INTRA-ARTICULAR ARTHROSCOPIC SHAVER (K874044)Medline Industries, Inc.1987-10-15
MODEL 28200C MICRO-ARTHROPLASTY SYSTEM (K871717)KARL STORZ Endoscopy-America, Inc.1987-06-05
HALL (R) MICRO E POWERED SURGICAL INSTRUMENT SYST (K864929)Hall Surgical, Division of Zimmer, Inc.1987-01-28
3M ARTHROSCOPIC SURGICAL SYSTEM (K855216)3M Company1986-03-04
INTRA-ARTICULATED ARTHROSCOPIC POWER SYSTEM (K854987)Richard Wolf Medical Instruments Corp.1986-02-11
MORGAN SUTURE-DRILL (K853376)Bowen & Company, Inc.1985-11-13
DEXTRA PRECISION POWER SYSTEM (K853489)Chattanooga Group, Inc.1985-09-30
TORQUE PLUS CATALOG 30120 (K833940)Concept, Inc.1983-12-28
C-BLADE (K802105)Cutter Laboratories, Inc.1980-09-16
INTRA-ARTICULATED EDGER-PLANER SYSTEM (K792353)Richard Wolf Medical Instruments Corp.1979-12-27
CHARNLEY FEMUR DRILL #1 AND #2 (K760977)Codman & Shurtleff, Inc.1976-11-16

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