Product Code: JDW FDA class 2 21 CFR 888.3040

Pin, Fixation, Threaded

Orthopedic

A Threaded Fixation Pin is an orthopedic implant used to stabilize bone fragments, fix small fractures, or anchor soft tissue to bone by means of a threaded shaft driven into osseous tissue. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification in addition to general and special controls. The product code is JDW, regulated under 21 CFR 888.3040, within the Orthopedic medical specialty. This device is flagged as an implant due to its surgical placement within the body.

View on FDA

510(k)s

FEI Numbers

184

Registration Numbers

184

Unique Applicants

Years Active

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Basic Information

Product Code: JDW
Device Class: FDA class 2
Regulation Number: 888.3040
Medical Specialty: Orthopedic
Review Panel: OR
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✓

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 94 510(k) clearances via K numbers.

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