FDA.reportPublic FDA data

Fixone Biocomposite Interference Screw

Primary DI
08800039100229
Brand
Fixone Biocomposite Interference Screw
Company
AJU PHARM. CO., LTD.
Model
IAB-90025a
Device description
The Fixone Biocomposite Interference Screws are intended to be used for fixation of bone-tendon-bone or softtissue grafts during anterior or posterior cruciate ligament reconstruction surgery.
Published
2025-01-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HWCScrew, Fixation, Bone

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K193497000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K193497000Fixone Biocomposite Interference ScrewAju Pharm Co., Ltd.2021-01-05HWC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800039100229PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800039100229088000391002298800039100229

GMDN Terms#

Term, Definition table
TermDefinition
Bioabsorbable orthopaedic bone screwA small, threaded, implantable rod with a slotted head typically used for internal orthopaedic fracture fixation by being screwed into bone to hold plates or nails to bone or to provide direct interfragmentary stabilization of bone, or it may fasten soft tissue to bone; it is made of a material that is chemically degraded and typically absorbed via natural body processes (e.g., degradable polymers). There are several kinds available: cortical, cancellous, malleolar, scaphoid, partially-threaded and fully-threaded. A "lag screw" can be any of these used to obtain compression across bone fragments.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
963422810
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800039100021Fixone Biocomposite AnchorBAB-45003ch2025-01-06
08800039100038Fixone Biocomposite AnchorBAB-55002dh2025-01-06
08800039100045Fixone Biocomposite AnchorBAB-55003ch2025-01-06
08800039100083Fixone Biocomposite AnchorKAB-55001ca2025-01-06
08800039100212Fixone Biocomposite Interference ScrewIAB-80025a2025-01-06
08800039100236Joinix Cannula SystemACS60072a2025-01-06
08800039100335Fixone Biocomposite AnchorSAL-30002i2025-01-06
08800039100380Fixone Biocomposite AnchorNAB-47502d2025-01-06
08800039100465Fixone All Suture AnchorFAS-1652803jw2025-01-06
08800039100502Fixone All Suture AnchorFAF-24615802ig2025-01-06
08800039100571Fixone Hybrid AnchorKAP-47501ca2025-01-06
08800039100601Fixone Hybrid AnchorKAP-55001ca2025-01-06
08800039100618Fixone InstrumentFixone.I.B-Awl450ak2025-01-06
08800039100625Fixone InstrumentFixone.I.B-Awl550ak2025-01-06
08800039100632Fixone InstrumentFixone.I.B-A/T450a2025-01-06
08800039100649Fixone InstrumentFixone.I.B-A/T550a2025-01-06
08800039100656Fixone InstrumentFixone.I.S-D/B3002025-01-06
08800039100663Fixone InstrumentFixone.I.S-D/G3002025-01-06
08800039100670Fixone InstrumentFixone.I.SL-D3002025-01-06
08800039100687Fixone InstrumentFixone.I.SL-G3002025-01-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03700569633943NANEWCLIP TECHNICSHWC2026-10-01
03700569633967NANEWCLIP TECHNICSHWC2026-10-01
03700569633981NANEWCLIP TECHNICSHWC2026-10-01
03700569634001NANEWCLIP TECHNICSHWC2026-10-01
03700569634025NANEWCLIP TECHNICSHWC2026-10-01
03700569634049NANEWCLIP TECHNICSHWC2026-10-01
03700569634063NANEWCLIP TECHNICSHWC2026-10-01
08057717550535BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2026-09-30
08057717550542BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2026-09-30
08057717550566BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2026-09-30
08057717550580BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2026-09-30
08057717550597BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2026-09-30
08057717550610BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2026-09-30
08057717550627BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2026-09-30
08057717550641BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2026-09-30
08057717550665BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2026-09-30
08057717550689BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2026-09-30
08057717550702BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2026-09-30
08057717550726BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2026-09-30
08057717550740BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2026-09-30
08057717550764BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2026-09-30
08057717550788BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2026-09-30
00885556838211Total Foot System 2Smith & Nephew, Inc.HWC2023-04-18
00815432024322DynaForce MotoBAND MaxCROSSROADS EXTREMITY SYSTEMSHWC2022-12-09
00815432024339DynaForce MotoBAND MaxCROSSROADS EXTREMITY SYSTEMSHWC2022-12-09
00815432024353DynaForce MotoBAND MaxCROSSROADS EXTREMITY SYSTEMSHWC2022-12-09
00815432024377DynaForce MotoBAND MaxCROSSROADS EXTREMITY SYSTEMSHWC2022-12-09
00815432024391DynaForce MotoBAND MaxCROSSROADS EXTREMITY SYSTEMSHWC2022-12-09
00815432024407DynaForce MotoBAND MaxCROSSROADS EXTREMITY SYSTEMSHWC2022-12-09
00815432024421DynaForce MotoBAND MaxCROSSROADS EXTREMITY SYSTEMSHWC2022-12-09