Atlas FDA

JDW

94 FDA 510(k) clearances · Product code

67 daysmedian time to decision
144 days90th percentile
94clearances measured

FDA profile

Official device name
Pin, Fixation, Threaded
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3040
Medical specialty
Orthopedic
Flags
Implant
Adverse events (MAUDE)
2020: 402 · 2021: 168 · 2022: 121 · 2023: 72 · 2024: 65 · 2025: 29
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
XT3 System; XT3 System, Mini; XT3 System, 40mm; XT3 System, Mini, 40mm (K260073)Biodynamik, Inc.2026-02-10
Meduloc Intramedullary Fracture Fixation (IFF) System (K250316)Meduloc, LLC2025-10-29
XT3 System (K241357)Biodynamik, Inc.2025-01-22
MAVERICK Mini External Fixation System (K223112)Smith & Nephew, Inc.2022-12-08
MAVERICK External Fixation System (K213874)Smith & Nephew, Inc.2022-02-11
Steinmann Pins and Kirschner Wires (K211508)Stryker GmbH2021-10-05
Extended HA Half Pins (K210784)Smith & Nephew, Inc.2021-04-02
Syntec Non-Sterile Steinmann Pins System (K200933)Syntec Scientific Corporation2020-05-05
Orthopedic Fixation Pin (K191803)Tinavi (Anhui) Medical Technologies Co., Ltd.2020-04-14
Temporary Fixation Pins (K192768)Eisertech, LLC2019-12-26
SMV Scientific K-Wire and Pins (K182171)Summit Medventures2018-10-25
Ultima HA Coated Half Pins and Wire (K163487)Vilex IN Tennessee, Inc.2017-02-13
ST.A.R. 90 F4 External Fixation Screws With Hydroxyapatite (K150661)Citieffe S.R.L.2015-07-07
VILEX ULTIMA EXTERNAL FIXATION SYSTEM WITH HA COATED PINS AND WIRES (K132820)Vilex, Inc.2014-07-23
OPTOSSOL COMPRESSION DEVICE SYSTEM (K140875)Genossis, LLC2014-05-30
AAP K-WIRE, STEINMANN PIN, CERCLAGE WIRE (K131459)Aap Implantate AG2013-10-17
BIOPRO KWICK-WIRE UNIVERSAL SCREW SYSTEM (K130298)Biopro, Inc.2013-06-18
SMITH & NEPHEW, INC. EXTERNAL FIXATION SYSTEM INSTRUMENTATION (K120871)Smith & Nephew, Inc.2012-06-07
ROCKWOOD CLAVICLE PINS (K103001)DePuy Orthopaedics, Inc.2011-02-17
TWISTCUT ENDOSORB SCREWS (K102777)Merete Medical GmbH2010-12-20
PROTOE ENDOSORB SMALL HAMMER TOE PIN (K100414)Merete Medical GmbH2010-07-02
ACUMED CLAVICLE SCREW SYSTEM (K083144)Acumed, LLC2009-06-16
NEXFIX COMPRESSION PIN (K072710)Nexa Orthopedics, Inc.2007-11-08
SBI TITANIUM THREADED PIN (K071540)Small Bone Innovations, Inc.2007-08-08
PIN SCREW (K061599)Bk Meditech, Co., Ltd.2006-07-26
APEX PINS (K061493)Stryker Howmedica Osteonics2006-07-07
ALLOFIX ANCHOR, 5.0 MM ANCHOR (K061498)Musculoskeletal Transplant Foundation2006-07-06
T-PIN (K053513)Union Surgical, LLC2006-01-13
TAPERED COMPRESSION PIN (K051740)Nexa Orthopedics, Inc.2005-09-06
SYNTHES 5.0/7.3 MM CANNULATED LOCKING SCREWS (K040765)Synthes (Usa)2004-04-12
MODIFICATION TO JET-X HA COATED HALF PINS (K033289)Smith & Nephew, Inc.2004-01-13
TARAS THREADED FIXATION PIN (K032532)Union Surgical, LLC2003-10-22
SINTEA BIOTECH SCHANZ SCREW, MODEL TFX.SS.XX.X (K031154)Sintea Biotech, Inc.2003-06-24
KMEDIC EXTERNAL FIXATION DEVICES (K030336)Teleflex Medical Group2003-03-06
JET-X HA COATED HALF PINS (K023921)Smith & Nephew, Inc.2003-02-05
JET-X TIN COATED HALF PINS (K023134)Smith & Nephew, Inc.2002-10-09
RADIOLUCENT COLLES COMPRESSION/DISTRACTION BAR (K021182)Biomet, Inc.2002-05-13
STRYKER INTERFERENCE SCREW CROSS PIN SYSTEM (K020097)Stryker Endoscopy2002-03-15
STRYKER CROSS-PINNED INTERFERENCE SCREW SYSTEM (K012270)Stryker Endoscopy2001-09-28
MODIFICATION TO THE TAC' PIN (K011875)New Deal, S.A.2001-09-06
STRYKER TITANIUM CROSS-SCREW SYSTEM, MODEL 234-500-1XX (K011319)Stryker Endoscopy2001-07-20
RESORBABLE HAMMERTOE PIN (K011137)Biomet, Inc.2001-06-19
APEX FIXATION PINS (K011136)Howmedica Osteonics Corp.2001-05-04
4.0/2.5 MM SELF-DRILLING SCHANZ SCREW (K002605)Synthes (Usa)2000-11-20
BIOMET LATERAL TROCH PLATE (K003294)Biomet, Inc.2000-11-03
MODIFICATION TO: RADIOLUCENT COLLES FRACTURE KIT (K003131)Biomet, Inc.2000-11-02
SYNTHES SACRAL BAR SYSTEM (K001720)Synthes (Usa)2000-08-24
APEX FIXATION PINS (K001886)Howmedica Osteonics Corp.2000-07-12
EXTERNAL FIXATION ANCHOR PIN (K001228)Immedica, Inc.2000-07-07
SMITH & NEPHEW EXTERNAL FIXATION SYSTEM [UNILATERAL (LINEAR) & MULTILATERAL (CIRCULAR) FIXATORS AND ACCESSORIES] (K994143)Smith & Nephew, Inc.2000-02-18
TAC' PIN (K993910)New Deal, S.A.2000-02-01
DIGIT WIDGET (K992970)Hand Biomechanics Lab, Inc.1999-11-08
DEPUY ROCKWOOD CLAVICLE PIN (K991649)Depuy, Inc.1999-07-14
STAINLESS STEEL FIXATION PINS (K990353)Bregma International Trading Company , Ltd.1999-06-01
SYNTEC-TAICHUNG NON-STERILE KNOWLES PIN, MODELS: FOR HEXAGONAL COLLAR: 2991-01/15,2992-01/15, FOR SQUARE COLLAR:29992-01 (K983757)Syntec Scientific Corp.1998-12-04
THREADED FIXATION PIN (K982931)Sgarlato Laboratories, Inc.1998-10-21
HOWMEDICA TITANIUM HOFFMANN FIXATION PIN SYSTEM (K982068)Howmedica Corp.1998-08-31
EXTERNAL FIXATION (K981716)Avanta Orthopaedics, Inc.1998-07-17
ALPHATEC WIRE EXTERNAL FIXATION SYSTEM (K980788)Alphatec Mfg., Inc.1998-05-22
ORTHOFIX EXTERNAL FIXATION SCREW (PIN) WITH HYDROXYAPATITE COATING (K974186)Orthofix Srl1998-03-18
EXTERNAL FIXATOR (K974911)Avanta Orthopaedics, Inc.1998-03-16
HEIDELBERG EXTERNAL FIXATOR (K970751)Smith & Nephew, Inc., Orthopaedic Div.1997-04-16
COMPASS UNIVERSAL HINGE (K970713)Smith & Nephew, Inc., Orthopaedic Div.1997-04-03
PROXIMAL FEMORAL NAIL (PFN) SYSTEM (K970097)Synthes (Usa)1997-03-13
HANSSON PIN SYSTEM (K964893)Osteonics Corp.1997-02-28
DEPUY CANNULATED CROSS PIN SCREW SYSTEM (K963973)Depuy, Inc.1996-12-16
THREADED FIXATION PIN (K963433)Orthopaedic Biosystems, Ltd.1996-11-06
CROSS PIN (K961920)Medicinelodge, Inc.1996-09-17
ORTHOFIX MODULSYSTEM (K955848)Orthofix, Inc.1996-03-20
KIRSHNER WIRES (K-WIRE) & STEINMANN PINS (K960023)Promex, Inc.1996-03-18
RIGIDYNE A EXTERNAL FIXATION SYSTEM (K955780)Zimmer, Inc.1996-02-09
DEPUY TITANIUM CROSS PIN FIXATION SYSTEM (K954630)Depuy, Inc.1995-12-13
POWERGRIP(TM) COMPRESSION FIXATION DEVICE (K950009)Synvasive Technology, Inc.1995-08-18
CANNULATED PLUS HIP SCREW (K952640)Wrightmedicaltechnologyinc1995-07-31
CROSS PIN SCREW SYSTEM (K946228)Depuy, Inc.1995-05-15
KIRSCHNER (K-WIRE), STEINMAN PINS (K945670)Brasseler USA I, L.P.1995-03-07
ORTHOPEDIC THREADED PIN FIXATION (K932349)Osteomed Corp.1994-03-01
HAGIE PIN (K905347)O'Tec Corp.1991-01-04
STEINMAN PIN, THREADED (K905336)O'Tec Corp.1990-12-11
KNOWLES PIN (K905344)O'Tec Corp.1990-12-11
STEINMAN PIN, THREAD (K903266)Onyx Medical Corp.1990-07-30
RUSH PIN (K903261)Onyx Medical Corp.1990-07-30
SKELETAL FIXATION PIN (K895173)Kronner Medical1989-09-12
FIXATOR PIN (EXTERNAL) (K881511)Orthopedic Systems, Inc.1988-06-30
ACE/FISCHER PERCUTANEOUS HALF PINS (K875012)Buckman Co., Inc.1988-01-14
ACE PERCUTANEOUS 3MM HALF-PINS (K875013)Buckman Co., Inc.1988-01-14
ACE/FISHER PERCUTANEOUS TRANSFIXING PINS (K875022)Buckman Co., Inc.1988-01-14
ACE AND ACE/FISCHER PRE-DRILL PIN SYSTEM (K875021)Buckman Co., Inc.1987-12-30
HOWMEDICA HOFFMANN FIXATION PIN SYSTEM (K861766)Howmedica Corp.1986-07-08
PARTIALLY THREADED BONE FIX. PIN (K842293)Warsaw Orthopedic, Inc.1984-08-02
BROOKER EXTERNAL FIXATION FRAME (K840286)Depuy, Inc.1984-02-09
CREIGHTON FIXATOR (K833907)Patton Machine Co.1984-02-09
THREADED PIN, SELF DRILLING (K781251)Ace Orthopedic Manufacturing Co.1978-08-31
GOUFFON PIN, ADJUSTABLE (K760454)Howmedica Corp.1976-08-26

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