Orthopedic

LXH · Orthopedic Manual Surgical Instrument

Orthopedic · 21 CFR 888.4540 · Class 1

Overview

Product CodeLXH
Device NameOrthopedic Manual Surgical Instrument
Regulation21 CFR 888.4540
Device ClassClass 1
Review PanelOrthopedic

Identification

An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery. This generic type of device includes the cerclage applier, awl, bender, drill brace, broach, burr, corkscrew, countersink, pin crimper, wire cutter, prosthesis driver, extractor, file, fork, needle holder, impactor, bending or contouring instrument, compression instrument, passer, socket positioner, probe, femoral neck punch, socket pusher, reamer, rongeur, scissors, screwdriver, bone skid, staple driver, bone screw starter, surgical stripper, tamp, bone tap, trephine, wire twister, and wrench.

Classification Rationale

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.

Cleared Devices (58)

RecordDevice NameApplicantDecision DateDecision
K192873SX-One MicroKnifeSonex Health, Inc.Dec 20, 2019SESE
K140414IMBIBE NEEDLEOrthovita, Inc.Apr 1, 2014SESE
K101609SELF RETAINING SOFT TISSUE RETRACTORKoros USA, Inc.Dec 9, 2010SESE
K001507MICROPERFORATION INSTRUMENTSmith & Nephew, Inc.Jun 14, 2000SESE
K952495ANCHORS AWAY SOFT TISSUE ATTACHMENT SYSTEMOrthopedic Systems, Inc.Jan 22, 1996SESE
K943873ORTHOMET ANATOMICALLY GUIDED CARPAL TUNNEL RELEASE SYOrthomet, Inc.Apr 26, 1995SESE
K944188SPINAL MARKERLeibinger L.P.Apr 13, 1995SESE
K941896STEADMAN LIGAMENT GRAFT PASSER AND PROTECTORDepuy, Inc.Nov 7, 1994SESE
K941711HYPERFLEX FLEXIBLE GUIDEWIRESLinvatec Corp.Aug 26, 1994SESE
K941605STRYKER FEMORAL CANAL BRUSH, ACETABULAR BRUSHStryker Corp.Aug 5, 1994SESE
K933772PUNCH SURGICALMahe-MedizintechnikFeb 1, 1994SESE
K933242SOFAMOR ORTHOPAEDIC INSTRUMENTSDanek Medical, Inc.Jan 28, 1994SESE
K934260BARRIER BONE WAX APPLICATORPhillips Pharmaceuticals, Inc.Jan 26, 1994SESE
K931846BIO-PREPBiomedical Devices, Inc.Jan 21, 1994SESE
K930028CALMPS: BONE, MASTIN, LEWIN, BRANDThomasville Medical Assoc.Feb 16, 1993SESE
K921402SURGICAL INSTRUMENT, DISPOSABLEMacro Medical, Inc.Jun 4, 1992SESE
K921645AMSEN SPINE IMPACTOR INSTRUMENTSAdvanced Med/Surg, Inc.Jun 3, 1992SESE
K921644AMSEN HOCKEY STICK CHISELAdvanced Med/Surg, Inc.Jun 3, 1992SESE
K921643AMSEN POSTERIOR DISC EVACUATORAdvanced Med/Surg, Inc.Jun 3, 1992SESE
K921642AMSEN DOUBLE-ENDED FORAMINAL PROBEAdvanced Med/Surg, Inc.Jun 3, 1992SESE
K901521OSTEOTOMES OF VARIOUS TYPESMumtaz I. MalikSep 28, 1990SESE
K901511CHISEL, BONE, SURGICALMumtaz I. MalikSep 28, 1990SESE
K901420VOLKMAN BONE CURRETTE 5, 5-3/4, 6-3/4, 8Mumtaz I. MalikSep 28, 1990SESE
K901289RONGEUR, ORTHOPEDIC SURGICAL INSTRUMENTSMumtaz I. MalikSep 28, 1990SESE
K902819LAMINECTOMY ROGEURRuggles Corp.Aug 9, 1990SESE
K903270T-HANDLE HEX WRENCHOnyx Medical Corp.Jul 30, 1990SESE
K903257DRIVER/EXTRACTOROnyx Medical Corp.Jul 30, 1990SESE
K903247ADJUSTABLE ANGLE GUIDEOnyx Medical Corp.Jul 30, 1990SESE
K895172KRONNER SACRAL PIN GUIDEKronner MedicalSep 12, 1989SESE
K891903COHN TARGETEEROrthopedic Systems, Inc.May 15, 1989SESE
K890168RETRACTOR, SELF-RETAININGDhason Brothers, Inc.Feb 13, 1989SESE
K890166RONGUER-ORTHOPEDICDhason Brothers, Inc.Feb 13, 1989SESE
K890164HUDSON BRACE W/BURRSDhason Brothers, Inc.Feb 13, 1989SESE
K890163AUSTIN MOORE HALLOW CHISELDhason Brothers, Inc.Feb 13, 1989SESE
K890162EXTRACTOR FOR AUSTIN MOORE FEMORAL HEADDhason Brothers, Inc.Feb 13, 1989SESE
K890161THOMPSON TYPE RASP W/TOMMY BARDhason Brothers, Inc.Feb 13, 1989SESE
K890160GOUGES FOR FEMORAL HEADSDhason Brothers, Inc.Feb 13, 1989SESE
K890158RETRACTORSDhason Brothers, Inc.Feb 13, 1989SESE
K890157FORCEPSDhason Brothers, Inc.Feb 13, 1989SESE
K890156IMPACTOR FOR FEMORAL HEADDhason Brothers, Inc.Feb 13, 1989SESE
K883694TENSIOMETERW. L. Gore & Associates, Inc.Nov 22, 1988SESE
K882077MICRODISCECTOMY CURRETTESKarlin Technology, Inc.Jun 17, 1988SESE
K882069SPINAL DISTRACTORS, SPANNERSKarlin Technology, Inc.Jun 17, 1988SESE
K880413PATELLAR TENDON GRAFT GUIDEConcept, Inc.Mar 4, 1988SESE
K860131ACROMED SPINAL SURGERY INSTRUMENTSBuckman Co., Inc.Mar 19, 1986SESE
K844595ORTHOPEDIC CUSTOM SURGICAL KITXanmed Corp.Aug 21, 1985SESE
K843942HENNING MENISCAL SUTURE KITStryker Corp.Apr 15, 1985SESE
K841970CAMELBACK HANDLE-K841969-LABELINGStainless Mfg., Inc.Jun 19, 1984SESE
K8419696.5MM HEX HANDLEStainless Mfg., Inc.Jun 19, 1984SESE
K834108NEEDLE BENDER TX8225Today'S Machining & Design, Inc.Mar 12, 1984SESE
K834370MULHOLLAN ARTHROSCOPIC NEEDLE CARRIERAcufex Microsurgical, Inc.Feb 27, 1984SESE
K834369CRANE MENISCAL SUTURE SETAcufex Microsurgical, Inc.Feb 27, 1984SESE
K833943MENISCAL SUTURING SYSTEMDyonics, Inc.Feb 27, 1984SESE
K813000DISPOSABLE ARTHROSCOPY CANNULA SETClinical Technology Corp.Jan 22, 1982SESE
K803127HOWMEDICA KNEE BRUSHHowmedica Corp.Feb 10, 1981SESE
K810267FEMORAL CANAL BRUSHRichard'S Medical Equip., Inc.Feb 9, 1981SESE
K802694JACOB CHUCKRichard Wolf Medical Instruments Corp.Nov 12, 1980SESE
K792670SMITH SUBTALAR PEGDow Corning WrightFeb 22, 1980SESE

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