FDA.reportPublic FDA data

SPEEDBUTTON

Primary DI
00815432028986
Brand
SPEEDBUTTON
Company
CROSSROADS EXTREMITY SYSTEMS
Model
SpeedButton Kit 1x4mm
Catalog number
32SB-KIT1
Device description
The SPEEDBUTTON™ Suture Anchor is intended to be used for suture or tissue fixation in the foot and ankle. Specific indications are listed below: Foot/Ankle: Lateral Stabilization, Medial Stabilization, Metatarsal Ligament Repair, Hallux Valgus reconstruction
Published
2021-01-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
MBIFastener, Fixation, Nondegradable, Soft Tissue

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MBIFastener, Fixation, Nondegradable, Soft TissueOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K153585000
K220797000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K153585000Flip Button Suture AnchorFirst Ray, LLC2016-05-05MBI
K220797000FootHold SystemCrossroads Extremity Systems, LLC2022-04-15MBI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815432028986PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815432028986008154320289868154320289860815432028986

GMDN Terms#

Term, Definition table
TermDefinition
Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterileA sterile assembly of implantable devices designed for the stabilization of fractured/surgically-cut bones of the limbs (long bones), their appendages (hands, feet), pelvis, craniomaxillofacial bones, and/or for limb-joint fusion. It typically consists of a set of bone fixation plates, screws, wires, and pins made of materials that cannot be chemically degraded or absorbed via natural body processes (e.g., implant grade metal, surgical steel, titanium alloy, or carbon fibre). It may also include instruments for the attachment of the implants such as screwdrivers or drills.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
058864308
Device count
1
Lot or batch
true
Expiration date on label
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
00810112593839TriLeap Lower Extremity Anatomic Plating System3.0 mm Ti Variable Angle Screw Length 9 mm, Gold04.906.0092024-02-22
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860016070004ICONN Revolution 6.5MM Knotless Suture AnchorICONN ORTHOPEDICS LLCMBI2026-07-16
10810128462867VersiTILT 2.4 x 8.5mm Implant SystemT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONMBI2026-07-16
10810128462874VersiTILT 2.4 x 8.5mm Button and InserterT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONMBI2026-07-16
10810128462881VersiTILT Drill Pin, 3.1mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONMBI2026-07-16
10810128462898VersiTILT Button, 2.4x8.5mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONMBI2026-07-16
10810128462904VersiTILT 2.4x12mm Implant System, LongT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONMBI2026-07-16
10810128462911VersiTILT 2.4x12mm Button and Inserter, LongT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONMBI2026-07-16
10810128462928VersiTILT Button, 2.4x12mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONMBI2026-07-16
10810128462935VersiTILT 3.1x10.9mm Implant System, XLT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONMBI2026-07-16
10810128462942VersiTILT 3.1x10.9mm Button and Inserter, XLT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONMBI2026-07-16
10810128462959VersiTILT Drill Pin, 3.6mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONMBI2026-07-16
10810128462966VersiTILT Button, 3.1x10.9mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONMBI2026-07-16
09353903030225OCTOPi Suture Anchor SystemFIELD ORTHOPAEDICS PTY LTDMBI2026-07-15
09353903030317OCTOPi Suture Anchor SystemFIELD ORTHOPAEDICS PTY LTDMBI2026-07-15
09353903030324OCTOPi Suture Anchor SystemFIELD ORTHOPAEDICS PTY LTDMBI2026-07-15
00810155331412Tigon MedicalTigon Medical LLCMBI2026-07-09
00850029805106Tigon MedicalTigon Medical LLCMBI2026-06-26
07901125601130GMReis Suture AnchorsGM DOS REIS INDUSTRIA E COMERCIO LTDAMBI2026-06-25
09353903030201Griplasty SystemFIELD ORTHOPAEDICS PTY LTDMBI2026-06-24
00860013918606ArthroTAK Tendon Anchor KitARTHROTAK, LLCMBI2026-06-08
00860013918613ArthroTAK Tendon Anchor KitARTHROTAK, LLCMBI2026-06-08
00860013918620ArthroTAK Tendon Anchor KitARTHROTAK, LLCMBI2026-06-08
00860013918637ArthroTAK Tendon Anchor KitARTHROTAK, LLCMBI2026-06-08
08720629959573SINEFIXBaat Medical Products B.V.MBI2026-04-01
08721515510151SINEFIXBaat Medical Products B.V.MBI2026-04-01
08101755018820HerculesIn2Bones USA, LLCMBI2026-03-30
08437019739744QuadLock™ Fixation System 9mmABANZA TECNOMED SL.MBI2026-01-14
08437019739751QuadLock™ Fixation System 10mmABANZA TECNOMED SL.MBI2026-01-14
08437019739768QuadLock™ Fixation System 11mmABANZA TECNOMED SL.MBI2026-01-14
00888867465220Arthrex®ARTHREX, INC.MBI2025-06-23