FDA.reportPublic FDA data

WishBone K - Wire System

Primary DI
B562KWSB0
Brand
WishBone K - Wire System
Company
Wishbone Medical, Inc.
Model
KWSB
Catalog number
KWSB
Device description
K-wire sports balls tip proctector, 3 pack
Published
2021-06-30
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
HTYPin, Fixation, Smooth
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTYPin, Fixation, SmoothOrthopedic2
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K173013000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K173013000WishBone K-Wire SystemWishbone Medical, Inc.2017-12-14HTY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B562KWSB0PrimaryHIBCC0

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

Regulatory Flags#

DUNS number
062355158
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B562PK301ELB1600K-WirePK-301-ELB1602023-03-16
B562PK301ELB2000K-WirePK-301-ELB2002023-03-16
B562PK301EXT1250K-WirePK-301-ELB2002023-03-16
B56213904001220S00WishBone K-Wire System13-904-001220S-013-904-001220S-02022-07-18
B56213904001220S10WishBone K-Wire System13-904-001220S-113-904-001220S-12022-07-18
B56213904001620S00WishBone K-Wire System13-904-001620S-013-904-001620S-02022-07-18
B56213904001620S10WishBone K-Wire System13-904-001620S-113-904-001620S-12022-07-18
B56213904002020S00WishBone K-Wire System13-904-002020S-013-904-002020S-02022-07-18
B56213904002020S10WishBone K-Wire System13-904-002020S-113-904-002020S-12022-07-18
B56213904002520S00WishBone K-Wire System13-904-002520S-013-904-002520S-02022-07-18
B56213904002520S10WishBone K-Wire System13-904-002520S-113-904-002520S-12022-07-18
B562PKKWELB0WishBone K-Wire SystemPK-KWELBPK-KWELB2020-12-02
B562PKKWELBUS0WishBone K-Wire SystemPK-KWELB-USPK-KWELB2020-12-02
B562PKKWEXT0WishBone K-Wire SystemPK-KWEXTPK-KWEXT2020-12-02
B562PKKWEXTUS0WishBone K-Wire SystemPK-KWEXT-USPK-KWEXT2020-12-02
B562KITKWIEXSML0Pediatric Extremity Combo K-Wire System-SMALLKIT-KWI-EXSML2019-03-28
B562KITKWIELBOW0Pediatric Elbow Combo K-Wire SystemKIT-KWI-ELBOW2019-03-18
B562KITKWIEXLAR0Pediatric Extremity Combo K-Wire SystemKIT-KWI-EXLAR2019-03-19
B562KITKWIEXMED0Pediatric Extremity Combo K-Wire SystemKIT-KWI-EXMED2019-03-19
B562KITKWILBONE0Pediatric Long Bone Combo K-Wire SystemKIT-KWI-LBONE2019-03-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613327648355PANGEAStryker GmbHLXH2026-06-02
07613327648379PANGEAStryker GmbHLXH2026-06-02
00199150077359Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-06-01
00199150077366Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-06-01
00816127027215InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLXH2026-06-01
00816127027246InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLXH2026-06-01
00816127027253InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLXH2026-06-01
00843511128777Omnia Medical TiBrid™-A/SAOMNIA MEDICAL, LLCLXH2026-06-01
00857915007712ObturatorA.M. SURGICAL, INC.LXH2026-06-01
00857915007729CannulaA.M. SURGICAL, INC.LXH2026-06-01
00857915007736RaspA.M. SURGICAL, INC.LXH2026-06-01
07630894830822APTUSMedartis AGHTY2026-06-01
07630894830839APTUSMedartis AGHTY2026-06-01
07630894830884APTUSMedartis AGHTY2026-06-01
07630894830891APTUSMedartis AGHTY2026-06-01
07899258648729Orthopedic InstrumentsGM DOS REIS INDUSTRIA E COMERCIO LTDALXH2026-06-01
B756007053002000Torque Wrench Adaptor HEX 3.5mmShukla MedicalLXH2026-06-01
10884450587727PowerCURVE®Merit Medical Systems, Inc.LXH2026-05-30
00818720013381SuperCable® ISO-Elastic™ Cerclage SystemKinamed, Inc.LXH2026-05-29
00843575124395Juveno™ Femoral Hip SystemB-ONE ORTHO, CORP.LXH2026-05-29
07630345728883Surgical Manual InstrumentMedacta International SALXH2026-05-29
07630542726170Surgical Manual InstrumentMedacta International SALXH2026-05-29
07630542753787Surgical Manual InstrumentMedacta International SALXH2026-05-29
07630542753794Surgical Manual InstrumentMedacta International SALXH2026-05-29
07630542788833Surgical Manual InstrumentMedacta International SALXH2026-05-29
07630542788840Surgical Manual InstrumentMedacta International SALXH2026-05-29
07630542788857Surgical Manual InstrumentMedacta International SALXH2026-05-29
07630542788864Surgical Manual InstrumentMedacta International SALXH2026-05-29
07630542788871Surgical Manual InstrumentMedacta International SALXH2026-05-29
07630542797699Surgical Manual InstrumentMedacta International SALXH2026-05-29