JDW · Pin, Fixation, Threaded
Orthopedic · 21 CFR 888.3040 · Class 2
Overview
| Product Code | JDW |
|---|---|
| Device Name | Pin, Fixation, Threaded |
| Regulation | 21 CFR 888.3040 |
| Device Class | Class 2 |
| Review Panel | Orthopedic |
| Implant | Yes |
Identification
A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.
Classification Rationale
Class II.
Cleared Devices (94)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K260073 | XT3 System; XT3 System, Mini; XT3 System, 40mm; XT3 System, Mini, 40mm | Biodynamik, Inc. | Feb 10, 2026 | SESE |
| K250316 | Meduloc Intramedullary Fracture Fixation (IFF) System | Meduloc, LLC | Oct 29, 2025 | SESE |
| K241357 | XT3 System | Biodynamik, Inc. | Jan 22, 2025 | SESE |
| K223112 | MAVERICK Mini External Fixation System | Smith & Nephew, Inc. | Dec 8, 2022 | SESE |
| K213874 | MAVERICK External Fixation System | Smith & Nephew, Inc. | Feb 11, 2022 | SESE |
| K211508 | Steinmann Pins and Kirschner Wires | Stryker GmbH | Oct 5, 2021 | SESE |
| K210784 | Extended HA Half Pins | Smith & Nephew, Inc. | Apr 2, 2021 | SESE |
| K200933 | Syntec Non-Sterile Steinmann Pins System | Syntec Scientific Corporation | May 5, 2020 | SESE |
| K191803 | Orthopedic Fixation Pin | Tinavi (Anhui) Medical Technologies Co., Ltd. | Apr 14, 2020 | SESE |
| K192768 | Temporary Fixation Pins | Eisertech, LLC | Dec 26, 2019 | SESE |
| K182171 | SMV Scientific K-Wire and Pins | Summit Medventures | Oct 25, 2018 | SESE |
| K163487 | Ultima HA Coated Half Pins and Wire | Vilex IN Tennessee, Inc. | Feb 13, 2017 | SESE |
| K150661 | ST.A.R. 90 F4 External Fixation Screws With Hydroxyapatite | Citieffe S.R.L. | Jul 7, 2015 | SESE |
| K132820 | VILEX ULTIMA EXTERNAL FIXATION SYSTEM WITH HA COATED PINS AND WIRES | Vilex, Inc. | Jul 23, 2014 | SESE |
| K140875 | OPTOSSOL COMPRESSION DEVICE SYSTEM | Genossis, LLC | May 30, 2014 | SESE |
| K131459 | AAP K-WIRE, STEINMANN PIN, CERCLAGE WIRE | Aap Implantate AG | Oct 17, 2013 | SESE |
| K130298 | BIOPRO KWICK-WIRE UNIVERSAL SCREW SYSTEM | Biopro, Inc. | Jun 18, 2013 | SESE |
| K120871 | SMITH & NEPHEW, INC. EXTERNAL FIXATION SYSTEM INSTRUMENTATION | Smith & Nephew, Inc. | Jun 7, 2012 | SESE |
| K103001 | ROCKWOOD CLAVICLE PINS | DePuy Orthopaedics, Inc. | Feb 17, 2011 | SESE |
| K102777 | TWISTCUT ENDOSORB SCREWS | Merete Medical GmbH | Dec 20, 2010 | SESE |
| K100414 | PROTOE ENDOSORB SMALL HAMMER TOE PIN | Merete Medical GmbH | Jul 2, 2010 | SESE |
| K083144 | ACUMED CLAVICLE SCREW SYSTEM | Acumed, LLC | Jun 16, 2009 | SESE |
| K072710 | NEXFIX COMPRESSION PIN | Nexa Orthopedics, Inc. | Nov 8, 2007 | SESE |
| K071540 | SBI TITANIUM THREADED PIN | Small Bone Innovations, Inc. | Aug 8, 2007 | SESE |
| K061599 | PIN SCREW | Bk Meditech, Co., Ltd. | Jul 26, 2006 | SESE |
| K061493 | APEX PINS | Stryker Howmedica Osteonics | Jul 7, 2006 | SESE |
| K061498 | ALLOFIX ANCHOR, 5.0 MM ANCHOR | Musculoskeletal Transplant Foundation | Jul 6, 2006 | SESE |
| K053513 | T-PIN | Union Surgical, LLC | Jan 13, 2006 | SESE |
| K051740 | TAPERED COMPRESSION PIN | Nexa Orthopedics, Inc. | Sep 6, 2005 | SESE |
| K040765 | SYNTHES 5.0/7.3 MM CANNULATED LOCKING SCREWS | Synthes (Usa) | Apr 12, 2004 | SESE |
| K033289 | MODIFICATION TO JET-X HA COATED HALF PINS | Smith & Nephew, Inc. | Jan 13, 2004 | SESE |
| K032532 | TARAS THREADED FIXATION PIN | Union Surgical, LLC | Oct 22, 2003 | SESE |
| K031154 | SINTEA BIOTECH SCHANZ SCREW, MODEL TFX.SS.XX.X | Sintea Biotech, Inc. | Jun 24, 2003 | SESE |
| K030336 | KMEDIC EXTERNAL FIXATION DEVICES | Teleflex Medical Group | Mar 6, 2003 | SESE |
| K023921 | JET-X HA COATED HALF PINS | Smith & Nephew, Inc. | Feb 5, 2003 | SESE |
| K023134 | JET-X TIN COATED HALF PINS | Smith & Nephew, Inc. | Oct 9, 2002 | SESE |
| K021182 | RADIOLUCENT COLLES COMPRESSION/DISTRACTION BAR | Biomet, Inc. | May 13, 2002 | SESE |
| K020097 | STRYKER INTERFERENCE SCREW CROSS PIN SYSTEM | Stryker Endoscopy | Mar 15, 2002 | SESE |
| K012270 | STRYKER CROSS-PINNED INTERFERENCE SCREW SYSTEM | Stryker Endoscopy | Sep 28, 2001 | SESE |
| K011875 | MODIFICATION TO THE TAC' PIN | New Deal, S.A. | Sep 6, 2001 | SESE |
| K011319 | STRYKER TITANIUM CROSS-SCREW SYSTEM, MODEL 234-500-1XX | Stryker Endoscopy | Jul 20, 2001 | SESE |
| K011137 | RESORBABLE HAMMERTOE PIN | Biomet, Inc. | Jun 19, 2001 | SESE |
| K011136 | APEX FIXATION PINS | Howmedica Osteonics Corp. | May 4, 2001 | SESE |
| K002605 | 4.0/2.5 MM SELF-DRILLING SCHANZ SCREW | Synthes (Usa) | Nov 20, 2000 | SESE |
| K003294 | BIOMET LATERAL TROCH PLATE | Biomet, Inc. | Nov 3, 2000 | SESE |
| K003131 | MODIFICATION TO: RADIOLUCENT COLLES FRACTURE KIT | Biomet, Inc. | Nov 2, 2000 | SESE |
| K001720 | SYNTHES SACRAL BAR SYSTEM | Synthes (Usa) | Aug 24, 2000 | SESE |
| K001886 | APEX FIXATION PINS | Howmedica Osteonics Corp. | Jul 12, 2000 | SESE |
| K001228 | EXTERNAL FIXATION ANCHOR PIN | Immedica, Inc. | Jul 7, 2000 | SESE |
| K994143 | SMITH & NEPHEW EXTERNAL FIXATION SYSTEM [UNILATERAL (LINEAR) & MULTILATERAL (CIRCULAR) FIXATORS AND ACCESSORIES] | Smith & Nephew, Inc. | Feb 18, 2000 | SESE |
| K993910 | TAC' PIN | New Deal, S.A. | Feb 1, 2000 | SESE |
| K992970 | DIGIT WIDGET | Hand Biomechanics Lab, Inc. | Nov 8, 1999 | SESE |
| K991649 | DEPUY ROCKWOOD CLAVICLE PIN | Depuy, Inc. | Jul 14, 1999 | SESE |
| K990353 | STAINLESS STEEL FIXATION PINS | Bregma International Trading Company , Ltd. | Jun 1, 1999 | SESE |
| 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. | Dec 4, 1998 | SESE |
| K982931 | THREADED FIXATION PIN | Sgarlato Laboratories, Inc. | Oct 21, 1998 | SESE |
| K982068 | HOWMEDICA TITANIUM HOFFMANN FIXATION PIN SYSTEM | Howmedica Corp. | Aug 31, 1998 | SESE |
| K981716 | EXTERNAL FIXATION | Avanta Orthopaedics, Inc. | Jul 17, 1998 | SESE |
| K980788 | ALPHATEC WIRE EXTERNAL FIXATION SYSTEM | Alphatec Mfg., Inc. | May 22, 1998 | SESE |
| K974186 | ORTHOFIX EXTERNAL FIXATION SCREW (PIN) WITH HYDROXYAPATITE COATING | Orthofix Srl | Mar 18, 1998 | SESE |
| K974911 | EXTERNAL FIXATOR | Avanta Orthopaedics, Inc. | Mar 16, 1998 | SESE |
| K970751 | HEIDELBERG EXTERNAL FIXATOR | Smith & Nephew, Inc., Orthopaedic Div. | Apr 16, 1997 | SESE |
| K970713 | COMPASS UNIVERSAL HINGE | Smith & Nephew, Inc., Orthopaedic Div. | Apr 3, 1997 | SESE |
| K970097 | PROXIMAL FEMORAL NAIL (PFN) SYSTEM | Synthes (Usa) | Mar 13, 1997 | SESE |
| K964893 | HANSSON PIN SYSTEM | Osteonics Corp. | Feb 28, 1997 | SESE |
| K963973 | DEPUY CANNULATED CROSS PIN SCREW SYSTEM | Depuy, Inc. | Dec 16, 1996 | SESE |
| K963433 | THREADED FIXATION PIN | Orthopaedic Biosystems, Ltd. | Nov 6, 1996 | SESE |
| K961920 | CROSS PIN | Medicinelodge, Inc. | Sep 17, 1996 | SESE |
| K955848 | ORTHOFIX MODULSYSTEM | Orthofix, Inc. | Mar 20, 1996 | SESE |
| K960023 | KIRSHNER WIRES (K-WIRE) & STEINMANN PINS | Promex, Inc. | Mar 18, 1996 | SESE |
| K955780 | RIGIDYNE A EXTERNAL FIXATION SYSTEM | Zimmer, Inc. | Feb 9, 1996 | SESE |
| K954630 | DEPUY TITANIUM CROSS PIN FIXATION SYSTEM | Depuy, Inc. | Dec 13, 1995 | SESE |
| K950009 | POWERGRIP(TM) COMPRESSION FIXATION DEVICE | Synvasive Technology, Inc. | Aug 18, 1995 | SESE |
| K952640 | CANNULATED PLUS HIP SCREW | Wrightmedicaltechnologyinc | Jul 31, 1995 | SESE |
| K946228 | CROSS PIN SCREW SYSTEM | Depuy, Inc. | May 15, 1995 | SESE |
| K945670 | KIRSCHNER (K-WIRE), STEINMAN PINS | Brasseler USA I, L.P. | Mar 7, 1995 | SESE |
| K932349 | ORTHOPEDIC THREADED PIN FIXATION | Osteomed Corp. | Mar 1, 1994 | SESE |
| K905347 | HAGIE PIN | O'Tec Corp. | Jan 4, 1991 | SN |
| K905344 | KNOWLES PIN | O'Tec Corp. | Dec 11, 1990 | SESE |
| K905336 | STEINMAN PIN, THREADED | O'Tec Corp. | Dec 11, 1990 | SESE |
| K903266 | STEINMAN PIN, THREAD | Onyx Medical Corp. | Jul 30, 1990 | SESE |
| K903261 | RUSH PIN | Onyx Medical Corp. | Jul 30, 1990 | SESE |
| K895173 | SKELETAL FIXATION PIN | Kronner Medical | Sep 12, 1989 | SESE |
| K881511 | FIXATOR PIN (EXTERNAL) | Orthopedic Systems, Inc. | Jun 30, 1988 | SESE |
| K875022 | ACE/FISHER PERCUTANEOUS TRANSFIXING PINS | Buckman Co., Inc. | Jan 14, 1988 | SESE |
| K875013 | ACE PERCUTANEOUS 3MM HALF-PINS | Buckman Co., Inc. | Jan 14, 1988 | SESE |
| K875012 | ACE/FISCHER PERCUTANEOUS HALF PINS | Buckman Co., Inc. | Jan 14, 1988 | SESE |
| K875021 | ACE AND ACE/FISCHER PRE-DRILL PIN SYSTEM | Buckman Co., Inc. | Dec 30, 1987 | SESE |
| K861766 | HOWMEDICA HOFFMANN FIXATION PIN SYSTEM | Howmedica Corp. | Jul 8, 1986 | SESE |
| K842293 | PARTIALLY THREADED BONE FIX. PIN | Warsaw Orthopedic, Inc. | Aug 2, 1984 | SESE |
| K840286 | BROOKER EXTERNAL FIXATION FRAME | Depuy, Inc. | Feb 9, 1984 | SESE |
| K833907 | CREIGHTON FIXATOR | Patton Machine Co. | Feb 9, 1984 | SESE |
| K781251 | THREADED PIN, SELF DRILLING | Ace Orthopedic Manufacturing Co. | Aug 31, 1978 | SESE |
| K760454 | GOUFFON PIN, ADJUSTABLE | Howmedica Corp. | Aug 26, 1976 | SESE |
Top Applicants
- Smith & Nephew, Inc. — 8 clearances
- Depuy, Inc. — 5 clearances
- Synthes (Usa) — 4 clearances
- Buckman Co., Inc. — 4 clearances
- Biomet, Inc. — 4 clearances
