Product Code: JDS FDA class 2 21 CFR 888.3030

Nail, Fixation, Bone

Orthopedic

A Bone Fixation Nail is an intramedullary implant inserted into the medullary canal of a long bone to stabilize and align fractures, particularly of the femur, tibia, or humerus. It is classified as FDA Class 2 (moderate risk), subject to general and special controls, and requires 510(k) premarket notification demonstrating substantial equivalence. The product code is JDS, regulated under 21 CFR 888.3030, within the Orthopedic medical specialty. This device is designated as an implant given its internal placement within the bone.

View on FDA

510(k)s

FEI Numbers

115

Registration Numbers

115

Unique Applicants

Years Active

Research product code JDS in seconds

The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

Free to try · every answer cites its records

Ask the Research Assistant See examples

Basic Information

Product Code: JDS
Device Class: FDA class 2
Regulation Number: 888.3030
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 53 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K243608	TRIGEN Stable Lock Nut & Washer	Jun 12, 2025	Substantially Equivalent	Smith & Nephew, Inc.
K240061	TRIGEN MAX Tibial Nail System; INTERTAN MAX Hip Fracture Nail System	Sep 20, 2024	Substantially Equivalent	Smith & Nephew, Inc.
K241804	TRIGEN INTERTAN 10S Nail System	Aug 22, 2024	Substantially Equivalent	Smith & Nephew, Inc.
K233150	NET BRAND Osteosynthesis Nailing System	Feb 20, 2024	Substantially Equivalent	Narang Medical , Ltd.
K230761	TRIGEN META-NAIL Nail System	Jun 14, 2023	Substantially Equivalent	Smith & Nephew, Inc.
K201336	DePuy Synthes Tibial Nail Advanced, Depuy Synthes Locking Screws Medullary Nails, 4.0 and 5.0mm	Sep 03, 2020	Substantially Equivalent	Synthes (USA) Products, LLC
K192003	Auxein Nailing System	Jun 10, 2020	Substantially Equivalent	Auxein Medical Private Limited
K193533	WIN Flexible Nail System	Feb 20, 2020	Substantially Equivalent	Biomet, Inc.
K141737	CONVENTUS PHS SYSTEM	Apr 08, 2015	Substantially Equivalent	Conventus Orthopaedics, Inc.
K123948	CHINA NAILS AND ACCESSORIES	Mar 14, 2013	Substantially Equivalent	Smith & Nephew, Inc.
K111667	SYNTHES SUPRAPATELLAR INSERTION INSTRUMENTS	Dec 05, 2011	Substantially Equivalent	Synthes (Usa)
K080706	CONNEXX LOCKING TIBIA NAIL	Jun 09, 2008	Substantially Equivalent	I.T.S. Implantat-Technologie-Systeme GmbH
K072095	SYNTHES (USA) PEDIATRIC LCP HIP PLATE SYSTEM MODIFICATIONS	Sep 27, 2007	Substantially Equivalent	Synthes (Usa)
K062872	SYNTHES (USA) PEDIATRIC LCP HIP PLATE SYSTEM	Mar 13, 2007	Substantially Equivalent	Synthes (Usa)
K061783	KNEE FUSION NAIL	Aug 10, 2006	Substantially Equivalent	Smith & Nephew, Inc.
K061019	TRIGEN META-NAIL RETROGRADE FEMORAL AND TIBIAL NAILS	Jun 06, 2006	Substantially Equivalent	Smith & Nephew, Inc.
K051557	TRIGEN RETROGRADE FEMORAL, SUPRACONDYLAR AND TIBIAL NAILS	Jun 30, 2005	Substantially Equivalent	Smith & Nephew, Inc.
K050938	KNEE FUSION NAIL	May 04, 2005	Substantially Equivalent	Smith & Nephew, Inc.
K040762	SYNTHES (USA) TIBIAL NAIL SYSTEM EX	Apr 12, 2004	Substantially Equivalent	Synthes (Usa)
K040212	TRIGEN INTERTAN	Feb 20, 2004	Substantially Equivalent	Smith & Nephew, Inc.
K033071	SYNTHES (USA) CANNULATED TITANIUM HUMERAL NAIL SYSTEM	Nov 05, 2003	Substantially Equivalent	Synthes (Usa)
K032634	NORMED COMPRESSION BONE SCREW SYSTEM	Oct 06, 2003	Substantially Equivalent	Noviace Corporation
K021782	BNF	Aug 26, 2002	Substantially Equivalent	Aap Implantate AG
K014189	ODI TALON INTRAMEDULLARY HIP NAIL	Mar 21, 2002	Substantially Equivalent	Orthopedic Designs, Inc.
K011504	BAUMER LOCKING NAIL	Aug 14, 2001	Substantially Equivalent	Baumer, S.A
K003212	FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM NAIL)	Dec 28, 2000	Substantially Equivalent	Disco-O-Tech Medical Technologies, Ltd.
K003215	MODIFICATION OF FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM NAIL)	Dec 27, 2000	Substantially Equivalent	Disco-O-Tech Medical Technologies, Ltd.
K002325	WUJIN #3 TIBIAL NAIL	Oct 30, 2000	Substantially Equivalent	Biologically Oriented Prostheses
K002729	SYNTHES PROXIMAL HUMERAL NAIL	Oct 06, 2000	Substantially Equivalent	Synthes (Usa)
K000764	PEDIATRIC FIXATION RODS	Apr 06, 2000	Substantially Equivalent	Biomet, Inc.
K993004	ALTA FULLY THREADED CROSS-LOCKING 5.0 MM SCREW	Oct 06, 1999	Substantially Equivalent	Howmedica Osteonics Corp.
K992348	SYNTHES SPIRAL BLADE FOR HUMERAL NAIL (SBHN)	Sep 23, 1999	Substantially Equivalent	Synthes (Usa)
K991877	MACMED PAEDIATRIC INTRAMEDULLARY NAIL	Aug 06, 1999	Substantially Equivalent	Innervision, Inc.
K991037	EUCLID REDUCTION AND GUIDANCE SYSTEM	Jun 23, 1999	Substantially Equivalent	Modular Cutting Systems, Inc.
K983942	INTRAMEDULLARY NAIL SYSTEM, LOCKING SCREW, NAIL CAP	Dec 04, 1998	Substantially Equivalent	Smith & Nephew, Inc.
K981529	TITANIUM INTRAMEDULLARY NAIL, TITANIUM LOCKING SCREW	Jul 09, 1998	Substantially Equivalent	Smith & Nephew, Inc.
K972516	SYNTHES (USA) FLEXIBLE HUMERAL NAIL(FLEX NAIL) SYSTEM	Sep 04, 1997	Substantially Equivalent	Synthes (Usa)
K962047	TITANIUM CANNULATED TIBIAL NAIL (TI CTN)	Jul 24, 1996	Substantially Equivalent	Synthes (Usa)
K943855	BONE FIXATION NAIL	Jul 12, 1995	Substantially Equivalent	Acu Med, Inc.
K951302	SMALL FRAGMENT PLATES AND SCREWS	May 05, 1995	Substantially Equivalent	Medpac
K940736	HAIG NAIL	Sep 12, 1994	Substantially Equivalent	Howmedica Corp.
K926465	FEMORAL INTRAMEDULLARY RODS	Aug 25, 1993	Substantially Equivalent	Applied Osteo Systems, Inc.
K924004	SEIDEL HUMERAL LOCKING NAIL -- ADDITIONAL LENGTHS	Nov 23, 1992	Substantially Equivalent	Howmedica Corp.
K914453	UNIVERSAL TIBIAL NAIL AND UNREAMED TIBIAL NAIL	Feb 18, 1992	Substantially Equivalent	Synthes (Usa)
K914371	UNIVERSAL FEMORAL NAIL	Feb 18, 1992	Substantially Equivalent	Synthes (Usa)
K883882	HUMERAL LOCKING NAIL SYSTEM	Jan 30, 1989	Substantially Equivalent	Howmedica Corp.
K884406	TRACER HIP PINNING SYSTEM	Nov 28, 1988	Substantially Equivalent	De Medica Mfg., Inc.
K840242	POLY PLUG CEMENT RESTRICTOR	May 30, 1984	Substantially Equivalent	Latham Manufacturer
K832328	INTRAMEDULLARY BONE PLUG	Oct 20, 1983	Substantially Equivalent	Kirschner Medical Corp.
K800898	SILASTIC BONE PLUG H.P.(CEMENT RESTRICT)	May 02, 1980	Substantially Equivalent	Dow Corning Corp. Healthcare Industries Materials
K800144	FEMORAL CEMENT RESTRICTOR	Feb 19, 1980	Substantially Equivalent	Biomet, Inc.
K800142	FUSON BONE PLUG, RADIOPAQUE	Feb 19, 1980	Substantially Equivalent	Zimmer, Inc.
K770130	B.G. FLEXIBLE NAIL SYSTEM	Jan 26, 1977	Substantially Equivalent	Howmedica Corp.