FDA.reportPublic FDA data

TriLeap Lower Extremity Anatomic Plating System

Primary DI
00810112593839
Brand
TriLeap Lower Extremity Anatomic Plating System
Company
CROSSROADS EXTREMITY SYSTEMS
Model
3.0 mm Ti Variable Angle Screw Length 9 mm, Gold
Catalog number
04.906.009
Device description
3.0 mm Ti Variable Angle Screw Length 9 mm, Gold
Published
2024-02-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
HRSPlate, Fixation, Bone
HWCScrew, Fixation, Bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRSPlate, Fixation, BoneOrthopedic2
HWCScrew, Fixation, BoneOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K230591000
K253178000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K230591000TriLEAP Plating SystemCrossroads Extremity Systems2023-09-29HRS
K253178000TRILEAP Plating SystemCrossroads Extremity Systems2026-01-06HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810112593839PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810112593839008101125938398101125938390810112593839

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone screw (non-sliding)A small, threaded, non-bioabsorbable, implantable rod intended for internal orthopaedic fixation by being screwed into a limb bone, rib, the sternum and/or pelvis to hold a plate, nail, rod or prosthesis to the bone, or to provide direct interfragmentary stabilization of a fractured bone; it is not intended to be introduced through the sleeve of a femoral neck fixation plate/sleeve, not used in dentistry/orthodontics, craniofacial or spinal bones, and not dedicated to intramedullary fixation/arthrodesis. It is typically of cortical or cancellous design and has a drive (e.g., slot, cross, star, polygonal) at its proximal end for introduction with a screwdriver.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
058864308
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810112592924TriLeap Lower Extremity Anatomic Plating System2.0 mm Ti Cortex Screw Length 13 mm, Blue04.901.0132024-02-21
00810112595758TriLeap Lower Extremity Anatomic Plating System1st MTP Ti Fusion Revision Plate, Medium, 5 Deg, L04.900.0192024-02-16
00810112592443TriLeap Lower Extremity Anatomic Plating SystemLapidus Screw Targeting Guide Left03.900.3982024-02-23
00810112596748TriLeap Lower Extremity Anatomic Plating System04.900.146049001462026-02-13
00810112596779TriLeap Lower Extremity Anatomic Plating System04.900.149049001492026-02-13
00810112598063MOTOBAND InstrumentsVIRTUGUIDE 0 RAC ROTATION - 10° - RT380004R-NSPKG2024-08-01
00810112598421MOTOBAND InstrumentsVIRTUGUIDE 1 RAC ROTATION - 5° - LT380006L-NSPKG2024-08-01
00815432022878MotoBANDMotoBAND CP, Non-Locking Screw, 3.5mm x 18mm - Ste1500-35182016-04-26
00810112594669TriLeap Lower Extremity Anatomic Plating System3.5 mm Ti Cortex Screw Length 32 mm, Dark Purple04.909.0322024-02-22
00810112595871TriLeap Lower Extremity Anatomic Plating System1st & 2nd Ti Lisfranc Joint Fusion Plate, Medium, 04.900.0332024-02-16
00815432026241HiMAX C7115-1515-C7115-1515-C2022-01-04
00815432029563MotoBANDImplant, 3.5mm x 34mm Anti-Drift Bolt, Fully Threa15FT-35342021-12-17
00815432022069CrossTIE™ 3.0mm 0Deg w/ Universal Inserter1443-33012016-03-09
00815432025459MotoBANDMotoBAND CP, Non-Locking Screw, 3mm x 28mm - Steri15NL-30282018-07-02
00815432026258HiMAX C7115-1818-C7115-1818-C2022-01-04
00815432028801MotoBANDImplant, 3.5mm x 32mm Anti-Drift Bolt15LP-35322020-05-27
00815432028818MotoBANDImplant, 3.5mm x 34mm Anti-Drift Bolt15LP-35342020-05-27
00815432028825MotoBANDImplant, 3.5mm x 36mm Anti-Drift Bolt15LP-35362020-05-27
00815432028832MotoBANDImplant, 3.5mm x 38mm Anti-Drift Bolt15LP-35382020-05-27
00815432028849MotoBANDImplant, 3.5mm x 40mm Anti-Drift Bolt15LP-35402020-05-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00885556819845Uni-CP Compression PlateSmith & Nephew, Inc.HRS2023-11-07
00885556819852Uni-CP Compression PlateSmith & Nephew, Inc.HRS2023-11-07
00885556819869Uni-CP Compression PlateSmith & Nephew, Inc.HRS2023-11-07
00885556819876Uni-CP Compression PlateSmith & Nephew, Inc.HRS2023-11-07
00885556819883Uni-CP Compression PlateSmith & Nephew, Inc.HRS2023-11-07
00885556819890Uni-CP Compression PlateSmith & Nephew, Inc.HRS2023-11-07
00885556819906Uni-CP Compression PlateSmith & Nephew, Inc.HRS2023-11-07
00885556819722Total Wrist FusionSmith & Nephew, Inc.HRS2023-10-26
00885556819746Total Wrist FusionSmith & Nephew, Inc.HRS2023-10-26
00885556819760Total Wrist FusionSmith & Nephew, Inc.HRS2023-10-26
00885556819807UNI-CP Compression PlateSmith & Nephew, Inc.HRS2023-10-26
00885556819814UNI-CP Compression PlateSmith & Nephew, Inc.HRS2023-10-26
00885556819821UNI-CP Compression PlateSmith & Nephew, Inc.HRS2023-10-26
00885556819838UNI-CP Compression PlateSmith & Nephew, Inc.HRS2023-10-26
00885556819623Total Wrist FusionSmith & Nephew, Inc.HRS2023-10-25
00885556819647SURFIXTotal Wrist FusionSmith & Nephew, Inc.HRS2023-10-25
00885556819661Total Wrist FusionSmith & Nephew, Inc.HRS2023-10-25
00885556819685Total Wrist FusionSmith & Nephew, Inc.HRS2023-10-25
00885556819708Total Wrist FusionSmith & Nephew, Inc.HRS2023-10-25
00885556838303Total Foot System 2Smith & Nephew, Inc.HWC2023-04-25
00885556838303Total Foot System 2Smith & Nephew, Inc.HRS2023-04-25
00885556838327Total Foot System 2Smith & Nephew, Inc.HWC2023-04-18
00885556838327Total Foot System 2Smith & Nephew, Inc.HRS2023-04-18
00885556824764DigiFuse Cannulated Intramedullary FusionSmith & Nephew, Inc.HWC2023-02-10
00885556824771DigiFuse Cannulated Intramedullary FusionSmith & Nephew, Inc.HWC2023-02-10
00885556824788DigiFuse Cannulated Intramedullary FusionSmith & Nephew, Inc.HWC2023-02-10
00885556824795DigiFuse Cannulated Intramedullary FusionSmith & Nephew, Inc.HWC2023-02-10
00885556824818DigiFuse Cannulated Intramedullary FusionSmith & Nephew, Inc.HWC2023-02-10
00885556824825DigiFuse Cannulated Intramedullary FusionSmith & Nephew, Inc.HWC2023-02-10
00885556835043Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22