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)
Top companies in JDS
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 21, 2025 | Synthes (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 |
JDS | K201336 K201346 |
| Oct 21, 2025 | Synthes (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 |
JDS | K201336 K201346 |
| Apr 22, 2022 | Smith & Nephew Orthopaedics GmbH INTERTAN 1.5 NAIL 13mm X 42cm 130DEG. Left
INTERTAN 1.5 NAIL 13mm X 42cm 130DEG. Right Open, Classified |
JDS | K040212 |
| Nov 2, 2020 | Smith & 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 |
JDS | K040212 |
| Jun 24, 2020 | Smith & 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 |
JDS | K061019 |
| Oct 24, 2017 | Smith & Nephew, Inc. smith&nephew TRIGEN INTERTAN 10S, REF 71675384, 10 MM X 18 CM NAIL, 130o (degrees), SET SCREW PREASSEMBLED IN NAIL Open, Classified |
JDS | K040212 |
| Mar 27, 2017 | Zimmer 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 |
JDS | K800144 |
| Jul 8, 2015 | Synthes, 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 |
JDS | K040762 |
| Aug 17, 2014 | Smith & 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 |
JDS | K040212 |
| May 20, 2014 | Smith & 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 |
JDS | K040212 |
| May 20, 2014 | Smith & 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 |
JDS | K040212 |
| Nov 27, 2013 | Synthes USA HQ, Inc. Synthes Titanium Cannulated Humeral Nail
Intended to aid in the alignment and stabilization of humeral fractures Terminated |
JDS | K033071 |
| Nov 26, 2013 | Synthes (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 |
JDS | K111667 |
| Mar 13, 2013 | Smith & 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 |
JDS | K981529 |
| Mar 13, 2013 | Smith & 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 |
JDS | K981529 |
| May 7, 2010 | Synthes 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 |
JDS | K992348 |
| May 7, 2010 | Synthes 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 |
JDS | K992348 |
| Jun 1, 2009 | Stryker Howmedica Osteonics Corp. Stryker, Gamma3, The Compact Version of the Gamma Nail System, Operative Technique for Hip Fracture System, Trochanteric and Long Nails. Terminated |
JDS | None listed |
| Jun 1, 2009 | Stryker Howmedica Osteonics Corp. Stryker, Gamma3S Trochanteric Nail 170, Operative Technique for Hip Fracture System. Terminated |
JDS | None listed |
| Jun 1, 2009 | Stryker Howmedica Osteonics Corp. Stryker, Gamma3 Plus Obese Targeting System, Operative Technique for Hip Fracture System, Trochanteric and Long Nails. Terminated |
JDS | None listed |
| Oct 7, 2005 | EBI, L.P. EBI Trochanteric 11mm Long Nail. Terminated |
JDS | K050118 |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.