ClearanceBrief
Panels › Orthopedic › Product code JDS · Class 2

Nail, Fixation, Bone

Regulation 888.3030

0510(k)s in 12 months (53 all time)
0recalls in 12 months (21 all time)
18recalls that name a 510(k)
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Top companies in JDS

DateFirm and productCodeLinked 510(k)
Oct 21, 2025Synthes (USA) Products LLC
LOW PROF LCKNG SCREW, F/IM NAIL 5.0MM / L, 42MM / XL25/ STER. Product Code: 04.045.342TS. Used in RFN-ADVANCEDTM Retrograde Femoral Nailing (RFNA) System and the Tibial Nail Advanced System.
Open, Classified
JDSK201336
K201346
Oct 21, 2025Synthes (USA) Products LLC
LOW PROF LCKNG SCREW, F/IM NAIL 5.0MM / L, 46MM / XL25/ STER. Product Code: 04.045.346TS. Used in RFN-ADVANCEDTM Retrograde Femoral Nailing (RFNA) System and the Tibial Nail Advanced System.
Open, Classified
JDSK201336
K201346
Apr 22, 2022Smith & Nephew Orthopaedics GmbH
INTERTAN 1.5 NAIL 13mm X 42cm 130DEG. Left INTERTAN 1.5 NAIL 13mm X 42cm 130DEG. Right
Open, Classified
JDSK040212
Nov 2, 2020Smith & Nephew, Inc.
Bone fixation nail. TRIGEN INTERTAN - Product Usage: indicated for fractures of the femur including simple shaft fractures, comminuted shaft fractures, spiral shaft fractures, long oblique shaft fract
Terminated
JDSK040212
Jun 24, 2020Smith & Nephew, Inc.
TRIGEN, Intramedullary nail - Product Usage: is intended to provide resistance for screw back-out. It provides additional friction to help hold the screws in place.
Terminated
JDSK061019
Oct 24, 2017Smith & Nephew, Inc.
smith&nephew TRIGEN INTERTAN 10S, REF 71675384, 10 MM X 18 CM NAIL, 130o (degrees), SET SCREW PREASSEMBLED IN NAIL
Open, Classified
JDSK040212
Mar 27, 2017Zimmer Biomet, Inc.
various polyethylene implants BIO PLUG 10MM Product Usage: Non-weight bearing accessory. Sterile, optional speciality components that are non-bioabsorbable, implantable devices designed to be inse
Terminated
JDSK800144
Jul 8, 2015Synthes, Inc.
TITANIUM END CAP WITH T40 STARDRIVE RECESS, 0MM EXTENSION FOR TITANIUM TIBIAL NAILS-EX; Synthes Tibial Nail System EX is intended to stabilize fractures of the proximal and distal tibia and the tibial
Terminated
JDSK040762
Aug 17, 2014Smith & Nephew, Inc.
TRIGEN(R) INTERTAN(TM) 10MM X 18 CM NAIL, 125o, REF 71675201, QTY (1), STERILE R, Smith & Nephew, Memphis, Inc., TN 38116 TRIGEN(R) INTERTAN(TM) 11.5MM X 18 CM NAIL, 125o, REF 71675202, QTY (1), STE
Terminated
JDSK040212
May 20, 2014Smith & Nephew Inc
TRIGEN INTERTAN 1.5 NAIL: (1) REF 71676515, 10 MM X 10 CM, 125 degree, LEFT, (2) REF 71676556, 11.5 MM X 36 CM, 125 degree, RIGHT, (3) REF 71676558, 11.5 MM X 38 CM, 125 degree, RIGHT, (4) REF 71
Terminated
JDSK040212
May 20, 2014Smith & Nephew Inc
TRIGEN INTERTAN NAIL: (1) REF 71675201, 10 MM X 18 CM, 125 degree, (2) REF 71675202, 11.5 MM X 18 CM, 125 degree, (3) REF 71675203, 13 MM X 18 CM, 125 degree, (4) REF 71675204, 10 MM X 20 CM, 125
Terminated
JDSK040212
Nov 27, 2013Synthes USA HQ, Inc.
Synthes Titanium Cannulated Humeral Nail Intended to aid in the alignment and stabilization of humeral fractures
Terminated
JDSK033071
Nov 26, 2013Synthes (USA) Products LLC
Synthes 14.5 mm Outer Protection Sleeve for Suprapatellar Synthes 14.5 mm Outer Protection Sleeve for Suprapatellar is used as part of the Synthes Tibial Nail System EX to stabilize fractures of the
Terminated
JDSK111667
Mar 13, 2013Smith & Nephew Inc
INTERNAL HEX RECON SCREW, TI-6AL-4V, REF 7162375, TRIGEN (R) INTERNAL HEX CAPTURED RECON SCREW, QTY: (1), 6.4 MM, 75 MM, TITANIUM, Smith & Nephew, Inc. Orthopedic. Bone screw for intramedullary rod f
Terminated
JDSK981529
Mar 13, 2013Smith & Nephew Inc
INTERNAL HEX RECON SCREW, TI-6AL-4V, REF 7162380, TRIGEN (R) INTERNAL HEX CAPTURED RECON SCREW, QTY: (1), 6.4 MM, 80 MM, TITANIUM, Smith & Nephew, Inc. Orthopedic. Bone screw for intramedullary rod f
Terminated
JDSK981529
May 7, 2010Synthes USA (HQ), Inc.
7.5mm Ti Solid Humeral Nail 250 mm Sterile Catalog number 462.725S Synthes Titanium Solid Humeral Nail System is intended for intramedullary fixation of a variety of humeral fractures using either an
Terminated
JDSK992348
May 7, 2010Synthes USA (HQ), Inc.
7.5mm Ti Solid Humeral Nail 230 mm Sterile Catalog number 462.723S Synthes Titanium Solid Humeral Nail System is intended for intramedullary fixation of a variety of humeral fractures using either an
Terminated
JDSK992348
Jun 1, 2009Stryker Howmedica Osteonics Corp.
Stryker, Gamma3, The Compact Version of the Gamma Nail System, Operative Technique for Hip Fracture System, Trochanteric and Long Nails.
Terminated
JDSNone listed
Jun 1, 2009Stryker Howmedica Osteonics Corp.
Stryker, Gamma3S Trochanteric Nail 170, Operative Technique for Hip Fracture System.
Terminated
JDSNone listed
Jun 1, 2009Stryker Howmedica Osteonics Corp.
Stryker, Gamma3 Plus Obese Targeting System, Operative Technique for Hip Fracture System, Trochanteric and Long Nails.
Terminated
JDSNone listed
Oct 7, 2005EBI, L.P.
EBI Trochanteric 11mm Long Nail.
Terminated
JDSK050118

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