FDA.reportPublic FDA data

K-Wire with stop 1.0mm

Primary DI
M209206660
Brand
K-Wire with stop 1.0mm
Company
BIOPRO, INC.
Model
20666
Published
2017-08-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
LRNWire, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRNWire, SurgicalOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K162674000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162674000BioPro Foot Plating SystemsBiopro, Inc.2017-06-16HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M209206660PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone wireA wire intended for the fixation of bone fractures that may be implanted or used short-term (e.g., to hold a plate in the correct position during an intervention). It may be used: 1) as a cerclage wire to aid bone fixation; 2) in a loop or figure-of-eight configuration to reattach, e.g., the tip of the elbow (olecranon), tibial tubercle, or greater trochanter; 3) to augment bone screw/plate fixation; or 4) as a Kirschner wire or K-Wire to stiffen (arthrodese) a toe or finger. It is made of metal [e.g., stainless steel, cobalt-chrome (Co-Cr)], and may be malleable or rigid; some types include a nut designed to be attached to the wire to prevent wire migration. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
618749857
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M209169570ACCU-CUT™ TWO STAGE169572015-09-16
M209169580ACCU-CUT™ TWO STAGE S169582015-09-16
M209173000ACCU-CUT™ 3mm OFFSET173002015-09-16
M209173060ACCU-CUT™ 3mm OFFSET S173062015-09-16
M209175020ACCU-CUT™ STANDARD W/2 BLADES175022015-09-16
M209175030ACCU-CUT™ 1mm OFFSET W/2 BLADES175032015-09-16
M209175040ACCU-CUT™ 2mm OFFSET W/2 BLADES175042015-09-16
M209175050ACCU-CUT™ 3mm OFFSET W/2 BLADES175052015-09-16
M209175060ACCU-CUT™ TWO STAGE W/2 BLADES175062015-09-16
M209177210ACCU-CUT™ STD MICRO CHOICE177212015-09-16
M209177330ACCU-CUT™ 1 mm MICRO CHOICE177332015-09-16
M209177340ACCU-CUT™ 2 mm MICRO CHOICE177342015-09-16
M209177350ACCU-CUT™ TWO STAGE MICRO177352015-09-16
M209185780ACCU-CUT™ 2mm W/THREADED K-WIRES185782015-09-16
M209195050ACCU-CUT™ STANDARD195052015-09-16
M209195060ACCU-CUT™ 1MM195062015-09-16
M209195070ACCU-CUT™ 2MM195072015-09-16
M209195080ACCU-CUT™ 3MM195082015-09-16
M209195090ACCU-CUT™ TWO STAGE195092015-09-16
M209195100ACCU-CUT™ LONG ARM195102015-09-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00840124516502FibFixFUSION ORTHOPEDICS, LLCLRN2026-04-09
00840124517509FibFixFUSION ORTHOPEDICS, LLCLRN2026-04-09
00840124517516FibFixFUSION ORTHOPEDICS, LLCLRN2026-04-09
00840124518551FibFixFUSION ORTHOPEDICS, LLCLRN2026-04-09
00840124524712FuzeFix Max FTFUSION ORTHOPEDICS, LLCLRN2025-11-03
00840124521599FuzeFix Max FTFUSION ORTHOPEDICS, LLCLRN2025-09-17
00840124521674FuzeFix Max FTFUSION ORTHOPEDICS, LLCLRN2025-09-17
00840124514843FuzeRightFUSION ORTHOPEDICS, LLCLRN2025-01-07
00840124514782LapiLockFUSION ORTHOPEDICS, LLCLRN2025-01-06
00840124514799LapiLockFUSION ORTHOPEDICS, LLCLRN2025-01-06
00840124514805LapiLockFUSION ORTHOPEDICS, LLCLRN2025-01-06
00840124514812LapiLockFUSION ORTHOPEDICS, LLCLRN2025-01-06
00840124514829LapiLockFUSION ORTHOPEDICS, LLCLRN2025-01-06
00840124514836LapiLockFUSION ORTHOPEDICS, LLCLRN2025-01-06
00673978047690ATLAS® Cable SystemMEDTRONIC SOFAMOR DANEK, INC.LRN2021-12-19
M20922794K-Wire with stop 1.0mmBIOPRO, INC.LRN2020-08-05
20705034764051NASynthes GmbHLRN2019-08-29
H9812920200NASYNTHES (U.S.A.) LPLRN2019-08-29
10603295210320NADEPUY INTERNATIONAL LTDLRN2018-09-24
00889024035546NAZimmer, Inc.LRN2017-09-26
10603295067740CONTROLDEPUY ORTHOPAEDICS, INC.LRN2017-07-21
20673978047885ATLAS® Cable SystemMEDTRONIC SOFAMOR DANEK, INC.LRN2016-06-25
20673978047977ATLAS® Cable SystemMEDTRONIC SOFAMOR DANEK, INC.LRN2016-06-25
20673978048004ATLAS® Cable SystemMEDTRONIC SOFAMOR DANEK, INC.LRN2016-06-25
04546540568083Dall-MilesHowmedica Osteonics Corp.LRN2015-09-24
04546540568090Dall-MilesHowmedica Osteonics Corp.LRN2015-09-24
04546540568106Dall-MilesHowmedica Osteonics Corp.LRN2015-09-24
04546540568113Dall-MilesHowmedica Osteonics Corp.LRN2015-09-24
04546540568120Dall-MilesHowmedica Osteonics Corp.LRN2015-09-24