FDA Product Code
FDA Product Code JDW — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Orthopedic
- 21 CFR Citation
- 888.3040
510(k) Clearances — 94 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K260073 | XT3 System; XT3 System, Mini; XT3 System, 40mm; XT3 System, Mini, 40mm | Biodynamik, Inc. | 2026-02-10 | Special | PDF ↗ |
| K250316 | Meduloc Intramedullary Fracture Fixation (IFF) System | Meduloc, LLC | 2025-10-29 | Traditional | PDF ↗ |
| K241357 | XT3 System | Biodynamik, Inc. | 2025-01-22 | Traditional | PDF ↗ |
| K223112 | MAVERICK Mini External Fixation System | Smith & Nephew, Inc. | 2022-12-08 | Traditional | PDF ↗ |
| K213874 | MAVERICK External Fixation System | Smith & Nephew, Inc. | 2022-02-11 | Traditional | PDF ↗ |
| K211508 | Steinmann Pins and Kirschner Wires | Stryker GmbH | 2021-10-05 | Traditional | PDF ↗ |
| K210784 | Extended HA Half Pins | Smith & Nephew, Inc. | 2021-04-02 | Special | PDF ↗ |
| K200933 | Syntec Non-Sterile Steinmann Pins System | Syntec Scientific Corporation | 2020-05-05 | Special | PDF ↗ |
| K191803 | Orthopedic Fixation Pin | Tinavi (Anhui) Medical Technologies Co., Ltd. | 2020-04-14 | Traditional | PDF ↗ |
| K192768 | Temporary Fixation Pins | Eisertech, LLC | 2019-12-26 | Traditional | PDF ↗ |
| K182171 | SMV Scientific K-Wire and Pins | Summit Medventures | 2018-10-25 | Traditional | PDF ↗ |
| K163487 | Ultima HA Coated Half Pins and Wire | Vilex IN Tennessee, Inc. | 2017-02-13 | Traditional | PDF ↗ |
| K150661 | ST.A.R. 90 F4 External Fixation Screws With Hydroxyapatite | Citieffe S.R.L. | 2015-07-07 | Traditional | PDF ↗ |
| K132820 | VILEX ULTIMA EXTERNAL FIXATION SYSTEM WITH HA COATED PINS AND WIRES | Vilex, Inc. | 2014-07-23 | Traditional | PDF ↗ |
| K140875 | OPTOSSOL COMPRESSION DEVICE SYSTEM | Genossis, LLC | 2014-05-30 | Traditional | PDF ↗ |
| K131459 | AAP K-WIRE, STEINMANN PIN, CERCLAGE WIRE | Aap Implantate AG | 2013-10-17 | Traditional | PDF ↗ |
| K130298 | BIOPRO KWICK-WIRE UNIVERSAL SCREW SYSTEM | Biopro, Inc. | 2013-06-18 | Traditional | PDF ↗ |
| K120871 | SMITH & NEPHEW, INC. EXTERNAL FIXATION SYSTEM INSTRUMENTATION | Smith & Nephew, Inc. | 2012-06-07 | Traditional | PDF ↗ |
| K103001 | ROCKWOOD CLAVICLE PINS | DePuy Orthopaedics, Inc. | 2011-02-17 | Traditional | PDF ↗ |
| K102777 | TWISTCUT ENDOSORB SCREWS | Merete Medical GmbH | 2010-12-20 | Traditional | PDF ↗ |
| K100414 | PROTOE ENDOSORB SMALL HAMMER TOE PIN | Merete Medical GmbH | 2010-07-02 | Traditional | PDF ↗ |
| K083144 | ACUMED CLAVICLE SCREW SYSTEM | Acumed, LLC | 2009-06-16 | Traditional | PDF ↗ |
| K072710 | NEXFIX COMPRESSION PIN | Nexa Orthopedics, Inc. | 2007-11-08 | Traditional | PDF ↗ |
| K071540 | SBI TITANIUM THREADED PIN | Small Bone Innovations, Inc. | 2007-08-08 | Traditional | PDF ↗ |
| K061599 | PIN SCREW | Bk Meditech, Co., Ltd. | 2006-07-26 | Traditional | PDF ↗ |
| K061493 | APEX PINS | Stryker Howmedica Osteonics | 2006-07-07 | Traditional | PDF ↗ |
| K061498 | ALLOFIX ANCHOR, 5.0 MM ANCHOR | Musculoskeletal Transplant Foundation | 2006-07-06 | Traditional | PDF ↗ |
| K053513 | T-PIN | Union Surgical, LLC | 2006-01-13 | Traditional | PDF ↗ |
| K051740 | TAPERED COMPRESSION PIN | Nexa Orthopedics, Inc. | 2005-09-06 | Traditional | PDF ↗ |
| K040765 | SYNTHES 5.0/7.3 MM CANNULATED LOCKING SCREWS | Synthes (Usa) | 2004-04-12 | Traditional | PDF ↗ |
| K033289 | MODIFICATION TO JET-X HA COATED HALF PINS | Smith & Nephew, Inc. | 2004-01-13 | Special | PDF ↗ |
| K032532 | TARAS THREADED FIXATION PIN | Union Surgical, LLC | 2003-10-22 | Traditional | PDF ↗ |
| K031154 | SINTEA BIOTECH SCHANZ SCREW, MODEL TFX.SS.XX.X | Sintea Biotech, Inc. | 2003-06-24 | Traditional | PDF ↗ |
| K030336 | KMEDIC EXTERNAL FIXATION DEVICES | Teleflex Medical Group | 2003-03-06 | Traditional | PDF ↗ |
| K023921 | JET-X HA COATED HALF PINS | Smith & Nephew, Inc. | 2003-02-05 | Special | PDF ↗ |
| K023134 | JET-X TIN COATED HALF PINS | Smith & Nephew, Inc. | 2002-10-09 | Special | PDF ↗ |
| K021182 | RADIOLUCENT COLLES COMPRESSION/DISTRACTION BAR | Biomet, Inc. | 2002-05-13 | Special | PDF ↗ |
| K020097 | STRYKER INTERFERENCE SCREW CROSS PIN SYSTEM | Stryker Endoscopy | 2002-03-15 | Traditional | PDF ↗ |
| K012270 | STRYKER CROSS-PINNED INTERFERENCE SCREW SYSTEM | Stryker Endoscopy | 2001-09-28 | Traditional | PDF ↗ |
| K011875 | MODIFICATION TO THE TAC' PIN | New Deal, S.A. | 2001-09-06 | Traditional | PDF ↗ |
| K011319 | STRYKER TITANIUM CROSS-SCREW SYSTEM, MODEL 234-500-1XX | Stryker Endoscopy | 2001-07-20 | Traditional | PDF ↗ |
| K011137 | RESORBABLE HAMMERTOE PIN | Biomet, Inc. | 2001-06-19 | Traditional | PDF ↗ |
| K011136 | APEX FIXATION PINS | Howmedica Osteonics Corp. | 2001-05-04 | Special | PDF ↗ |
| K002605 | 4.0/2.5 MM SELF-DRILLING SCHANZ SCREW | Synthes (Usa) | 2000-11-20 | Traditional | PDF ↗ |
| K003294 | BIOMET LATERAL TROCH PLATE | Biomet, Inc. | 2000-11-03 | Special | PDF ↗ |
| K003131 | MODIFICATION TO: RADIOLUCENT COLLES FRACTURE KIT | Biomet, Inc. | 2000-11-02 | Special | PDF ↗ |
| K001720 | SYNTHES SACRAL BAR SYSTEM | Synthes (Usa) | 2000-08-24 | Traditional | PDF ↗ |
| K001886 | APEX FIXATION PINS | Howmedica Osteonics Corp. | 2000-07-12 | Special | PDF ↗ |
| K001228 | EXTERNAL FIXATION ANCHOR PIN | Immedica, Inc. | 2000-07-07 | Traditional | PDF ↗ |
| K994143 | SMITH & NEPHEW EXTERNAL FIXATION SYSTEM [UNILATERAL (LINEAR) & MULTILATERAL (CIRCULAR) FIXATORS AND ACCESSORIES] | Smith & Nephew, Inc. | 2000-02-18 | Traditional | PDF ↗ |
| K993910 | TAC' PIN | New Deal, S.A. | 2000-02-01 | Traditional | PDF ↗ |
| K992970 | DIGIT WIDGET | Hand Biomechanics Lab, Inc. | 1999-11-08 | Traditional | PDF ↗ |
| K991649 | DEPUY ROCKWOOD CLAVICLE PIN | Depuy, Inc. | 1999-07-14 | Traditional | PDF ↗ |
| K990353 | STAINLESS STEEL FIXATION PINS | Bregma International Trading Company , Ltd. | 1999-06-01 | Traditional | PDF ↗ |
| K983757 | SYNTEC-TAICHUNG NON-STERILE KNOWLES PIN, MODELS: FOR HEXAGONAL COLLAR: 2991-01/15,2992-01/15, FOR SQUARE COLLAR:29992-01 | Syntec Scientific Corp. | 1998-12-04 | Traditional | PDF ↗ |
| K982931 | THREADED FIXATION PIN | Sgarlato Laboratories, Inc. | 1998-10-21 | Traditional | PDF ↗ |
| K982068 | HOWMEDICA TITANIUM HOFFMANN FIXATION PIN SYSTEM | Howmedica Corp. | 1998-08-31 | Traditional | PDF ↗ |
| K981716 | EXTERNAL FIXATION | Avanta Orthopaedics, Inc. | 1998-07-17 | Traditional | PDF ↗ |
| K980788 | ALPHATEC WIRE EXTERNAL FIXATION SYSTEM | Alphatec Mfg., Inc. | 1998-05-22 | Traditional | PDF ↗ |
| K974186 | ORTHOFIX EXTERNAL FIXATION SCREW (PIN) WITH HYDROXYAPATITE COATING | Orthofix Srl | 1998-03-18 | Traditional | PDF ↗ |
| K974911 | EXTERNAL FIXATOR | Avanta Orthopaedics, Inc. | 1998-03-16 | Traditional | PDF ↗ |
| K970751 | HEIDELBERG EXTERNAL FIXATOR | Smith & Nephew, Inc., Orthopaedic Div. | 1997-04-16 | Traditional | PDF ↗ |
| K970713 | COMPASS UNIVERSAL HINGE | Smith & Nephew, Inc., Orthopaedic Div. | 1997-04-03 | Traditional | PDF ↗ |
| K970097 | PROXIMAL FEMORAL NAIL (PFN) SYSTEM | Synthes (Usa) | 1997-03-13 | Traditional | PDF ↗ |
| K964893 | HANSSON PIN SYSTEM | Osteonics Corp. | 1997-02-28 | Traditional | PDF ↗ |
| K963973 | DEPUY CANNULATED CROSS PIN SCREW SYSTEM | Depuy, Inc. | 1996-12-16 | Traditional | PDF ↗ |
| K963433 | THREADED FIXATION PIN | Orthopaedic Biosystems, Ltd. | 1996-11-06 | Traditional | PDF ↗ |
| K961920 | CROSS PIN | Medicinelodge, Inc. | 1996-09-17 | Traditional | PDF ↗ |
| K955848 | ORTHOFIX MODULSYSTEM | Orthofix, Inc. | 1996-03-20 | Traditional | PDF ↗ |
| K960023 | KIRSHNER WIRES (K-WIRE) & STEINMANN PINS | Promex, Inc. | 1996-03-18 | Traditional | PDF ↗ |
| K955780 | RIGIDYNE A EXTERNAL FIXATION SYSTEM | Zimmer, Inc. | 1996-02-09 | Traditional | PDF ↗ |
| K954630 | DEPUY TITANIUM CROSS PIN FIXATION SYSTEM | Depuy, Inc. | 1995-12-13 | Traditional | PDF ↗ |
| K950009 | POWERGRIP(TM) COMPRESSION FIXATION DEVICE | Synvasive Technology, Inc. | 1995-08-18 | Traditional | PDF ↗ |
| K952640 | CANNULATED PLUS HIP SCREW | Wrightmedicaltechnologyinc | 1995-07-31 | Traditional | PDF ↗ |
| K946228 | CROSS PIN SCREW SYSTEM | Depuy, Inc. | 1995-05-15 | Traditional | PDF ↗ |
| K945670 | KIRSCHNER (K-WIRE), STEINMAN PINS | Brasseler USA I, L.P. | 1995-03-07 | Traditional | PDF ↗ |
| K932349 | ORTHOPEDIC THREADED PIN FIXATION | Osteomed Corp. | 1994-03-01 | Traditional | PDF ↗ |
| K905347 | HAGIE PIN | O'Tec Corp. | 1991-01-04 | Traditional | PDF ↗ |
| K905336 | STEINMAN PIN, THREADED | O'Tec Corp. | 1990-12-11 | Traditional | PDF ↗ |
| K905344 | KNOWLES PIN | O'Tec Corp. | 1990-12-11 | Traditional | PDF ↗ |
| K903266 | STEINMAN PIN, THREAD | Onyx Medical Corp. | 1990-07-30 | Traditional | PDF ↗ |
| K903261 | RUSH PIN | Onyx Medical Corp. | 1990-07-30 | Traditional | PDF ↗ |
| K895173 | SKELETAL FIXATION PIN | Kronner Medical | 1989-09-12 | Traditional | PDF ↗ |
| K881511 | FIXATOR PIN (EXTERNAL) | Orthopedic Systems, Inc. | 1988-06-30 | Traditional | PDF ↗ |
| K875013 | ACE PERCUTANEOUS 3MM HALF-PINS | Buckman Co., Inc. | 1988-01-14 | Traditional | PDF ↗ |
| K875012 | ACE/FISCHER PERCUTANEOUS HALF PINS | Buckman Co., Inc. | 1988-01-14 | Traditional | PDF ↗ |
| K875022 | ACE/FISHER PERCUTANEOUS TRANSFIXING PINS | Buckman Co., Inc. | 1988-01-14 | Traditional | PDF ↗ |
| K875021 | ACE AND ACE/FISCHER PRE-DRILL PIN SYSTEM | Buckman Co., Inc. | 1987-12-30 | Traditional | PDF ↗ |
| K861766 | HOWMEDICA HOFFMANN FIXATION PIN SYSTEM | Howmedica Corp. | 1986-07-08 | Traditional | PDF ↗ |
| K842293 | PARTIALLY THREADED BONE FIX. PIN | Warsaw Orthopedic, Inc. | 1984-08-02 | Traditional | PDF ↗ |
| K840286 | BROOKER EXTERNAL FIXATION FRAME | Depuy, Inc. | 1984-02-09 | Traditional | PDF ↗ |
| K833907 | CREIGHTON FIXATOR | Patton Machine Co. | 1984-02-09 | Traditional | PDF ↗ |
| K781251 | THREADED PIN, SELF DRILLING | Ace Orthopedic Manufacturing Co. | 1978-08-31 | Traditional | PDF ↗ |
| K760454 | GOUFFON PIN, ADJUSTABLE | Howmedica Corp. | 1976-08-26 | Traditional | PDF ↗ |
Product code JDW · Class II · Orthopedic. Data: openFDA.