FDA.reportPublic FDA data

Biosteon® Screw

Primary DI
15060155710263
Brand
Biosteon® Screw
Company
BIOCOMPOSITES LTD
Model
234-010-163
Catalog number
234-010-163
Device description
The Biosteon® ACL screw is a cannulated single-use bone screw made of a resorbable Poly (L-latic) Acid and calcium phosphate which will be gradually resorbed into the body. This function however, is patient dependent.
Published
2015-07-24
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
HWCScrew, Fixation, Bone

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15060155710263PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1506015571026315060155710263

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone screw, bioabsorbableA small, sterile, threaded 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). This device may be used in maxillofacial surgery. There are a number of 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length23Millimeter
Width9Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature4 Degrees Celsius47 Degrees Celsius
Storage Environment Temperature39 Degrees Fahrenheit117 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+441782338580info@biocomposites.com

Regulatory Flags#

DUNS number
424382307
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
15060155712205Synicem Knee Spacer Trial Tray with Trials8820248820242025-07-08
15060155712328Synicem 58 Knee Trial FDA8854188854182025-07-08
15060155712342Synicem 65 Knee Trial FDA8854198854192025-07-08
15060155712366Synicem 72 Knee Trial FDA8854208854202025-07-08
15060155712380Synicem 79 Knee Trial FDA8854218854212025-07-08
15060155712700Synicem Knee Spacer Trial Case (marked)5150905150902025-07-08
15060155712021Synicem Hip Spacer 40C8854308854302025-07-08
15060155712038Synicem Hip Spacer 48C8854318854312025-07-08
15060155712045Synicem Hip Spacer 56C8854328854322025-07-08
15060155712052Synicem Hip Spacer 40CXL8854338854332025-07-08
15060155712069Synicem Hip Spacer 48CXL8854348854342025-07-08
15060155712076Synicem Hip Spacer 56CXL8854358854352025-07-08
15060155712083Synicem Hip Spacer 48M8854368854362025-07-08
15060155712090Synicem Hip Spacer 56M8854378854372025-07-08
15060155712106Synicem Hip Spacer Trial Tray Regular with Trials8820228820222025-07-08
15060155712113Synicem Hip Spacer Trial Tray XL with Trials8820238820232025-07-08
15060155712120Synicem Knee Spacer R588854388854382025-07-08
15060155712137Synicem Knee Spacer L588854398854392025-07-08
15060155712144Synicem Knee Spacer R658854408854402025-07-08
15060155712151Synicem Knee Spacer L658854418854412025-07-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00841731140425ARTEMIS FUZEVILEX LLCHWC2026-07-22
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00841731140449ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140456ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140463ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140470ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140487ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140494ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140500ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140517ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140524ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140531ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140548ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140555ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140562ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140593ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140609ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140616ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140623ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140630ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140647ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140654ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140661ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140678ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140685ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140692ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140708ARTEMIS FUZEVILEX LLCHWC2026-07-22