Atlas FDA

LXH

58 FDA 510(k) clearances · Product code

58 daysmedian time to decision
210 days90th percentile
58clearances measured

FDA profile

Official device name
Orthopedic Manual Surgical Instrument
Device class
Class I (low risk)
Regulation
21 CFR 888.4540
Medical specialty
Orthopedic
Adverse events (MAUDE)
2021: 4,832 · 2022: 4,844 · 2023: 5,163 · 2024: 6,319 · 2025: 6,198 · 2026: 3,316
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
SX-One MicroKnife (K192873)Sonex Health, Inc.2019-12-20
IMBIBE NEEDLE (K140414)Orthovita, Inc.2014-04-01
SELF RETAINING SOFT TISSUE RETRACTOR (K101609)Koros USA, Inc.2010-12-09
MICROPERFORATION INSTRUMENT (K001507)Smith & Nephew, Inc.2000-06-14
ANCHORS AWAY SOFT TISSUE ATTACHMENT SYSTEM (K952495)Orthopedic Systems, Inc.1996-01-22
ORTHOMET ANATOMICALLY GUIDED CARPAL TUNNEL RELEASE SY (K943873)Orthomet, Inc.1995-04-26
SPINAL MARKER (K944188)Leibinger L.P.1995-04-13
STEADMAN LIGAMENT GRAFT PASSER AND PROTECTOR (K941896)Depuy, Inc.1994-11-07
HYPERFLEX FLEXIBLE GUIDEWIRES (K941711)Linvatec Corp.1994-08-26
STRYKER FEMORAL CANAL BRUSH, ACETABULAR BRUSH (K941605)Stryker Corp.1994-08-05
PUNCH SURGICAL (K933772)Mahe-Medizintechnik1994-02-01
SOFAMOR ORTHOPAEDIC INSTRUMENTS (K933242)Danek Medical, Inc.1994-01-28
BARRIER BONE WAX APPLICATOR (K934260)Phillips Pharmaceuticals, Inc.1994-01-26
BIO-PREP (K931846)Biomedical Devices, Inc.1994-01-21
CALMPS: BONE, MASTIN, LEWIN, BRAND (K930028)Thomasville Medical Assoc.1993-02-16
SURGICAL INSTRUMENT, DISPOSABLE (K921402)Macro Medical, Inc.1992-06-04
AMSEN POSTERIOR DISC EVACUATOR (K921643)Advanced Med/Surg, Inc.1992-06-03
AMSEN HOCKEY STICK CHISEL (K921644)Advanced Med/Surg, Inc.1992-06-03
AMSEN SPINE IMPACTOR INSTRUMENTS (K921645)Advanced Med/Surg, Inc.1992-06-03
AMSEN DOUBLE-ENDED FORAMINAL PROBE (K921642)Advanced Med/Surg, Inc.1992-06-03
OSTEOTOMES OF VARIOUS TYPES (K901521)Mumtaz I. Malik1990-09-28
CHISEL, BONE, SURGICAL (K901511)Mumtaz I. Malik1990-09-28
VOLKMAN BONE CURRETTE 5, 5-3/4, 6-3/4, 8 (K901420)Mumtaz I. Malik1990-09-28
RONGEUR, ORTHOPEDIC SURGICAL INSTRUMENTS (K901289)Mumtaz I. Malik1990-09-28
LAMINECTOMY ROGEUR (K902819)Ruggles Corp.1990-08-09
ADJUSTABLE ANGLE GUIDE (K903247)Onyx Medical Corp.1990-07-30
DRIVER/EXTRACTOR (K903257)Onyx Medical Corp.1990-07-30
T-HANDLE HEX WRENCH (K903270)Onyx Medical Corp.1990-07-30
KRONNER SACRAL PIN GUIDE (K895172)Kronner Medical1989-09-12
COHN TARGETEER (K891903)Orthopedic Systems, Inc.1989-05-15
IMPACTOR FOR FEMORAL HEAD (K890156)Dhason Brothers, Inc.1989-02-13
AUSTIN MOORE HALLOW CHISEL (K890163)Dhason Brothers, Inc.1989-02-13
RETRACTOR, SELF-RETAINING (K890168)Dhason Brothers, Inc.1989-02-13
RETRACTORS (K890158)Dhason Brothers, Inc.1989-02-13
EXTRACTOR FOR AUSTIN MOORE FEMORAL HEAD (K890162)Dhason Brothers, Inc.1989-02-13
THOMPSON TYPE RASP W/TOMMY BAR (K890161)Dhason Brothers, Inc.1989-02-13
FORCEPS (K890157)Dhason Brothers, Inc.1989-02-13
RONGUER-ORTHOPEDIC (K890166)Dhason Brothers, Inc.1989-02-13
HUDSON BRACE W/BURRS (K890164)Dhason Brothers, Inc.1989-02-13
GOUGES FOR FEMORAL HEADS (K890160)Dhason Brothers, Inc.1989-02-13
TENSIOMETER (K883694)W. L. Gore & Associates, Inc.1988-11-22
MICRODISCECTOMY CURRETTES (K882077)Karlin Technology, Inc.1988-06-17
SPINAL DISTRACTORS, SPANNERS (K882069)Karlin Technology, Inc.1988-06-17
PATELLAR TENDON GRAFT GUIDE (K880413)Concept, Inc.1988-03-04
ACROMED SPINAL SURGERY INSTRUMENTS (K860131)Buckman Co., Inc.1986-03-19
ORTHOPEDIC CUSTOM SURGICAL KIT (K844595)Xanmed Corp.1985-08-21
HENNING MENISCAL SUTURE KIT (K843942)Stryker Corp.1985-04-15
CAMELBACK HANDLE-K841969-LABELING (K841970)Stainless Mfg., Inc.1984-06-19
6.5MM HEX HANDLE (K841969)Stainless Mfg., Inc.1984-06-19
NEEDLE BENDER TX8225 (K834108)Today'S Machining & Design, Inc.1984-03-12
CRANE MENISCAL SUTURE SET (K834369)Acufex Microsurgical, Inc.1984-02-27
MENISCAL SUTURING SYSTEM (K833943)Dyonics, Inc.1984-02-27
MULHOLLAN ARTHROSCOPIC NEEDLE CARRIER (K834370)Acufex Microsurgical, Inc.1984-02-27
DISPOSABLE ARTHROSCOPY CANNULA SET (K813000)Clinical Technology Corp.1982-01-22
HOWMEDICA KNEE BRUSH (K803127)Howmedica Corp.1981-02-10
FEMORAL CANAL BRUSH (K810267)Richard'S Medical Equip., Inc.1981-02-09
JACOB CHUCK (K802694)Richard Wolf Medical Instruments Corp.1980-11-12
SMITH SUBTALAR PEG (K792670)Dow Corning Wright1980-02-22

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