FDA.reportPublic FDA data

SpaceFlex Hip

Primary DI
08058964726889
Brand
SpaceFlex Hip
Company
G21 SRL
Model
900005 10
Device description
Disposable custom modular spacer mold
Published
2019-11-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KWLProsthesis, Hip, Hemi-, Femoral, Metal
KWYProsthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
MBBBone Cement, Antibiotic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWLProsthesis, Hip, Hemi-, Femoral, MetalOrthopedic2
KWYProsthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or UncementedOrthopedic2
MBBBone Cement, AntibioticOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K192041000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192041000G21 SpaceFlex HipG21, S.R.L.2019-10-29MBB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08058964726889PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08058964726889080589647268898058964726889

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic cement spacer mouldA moulding device designed to form an implantable provisional joint prosthesis component out of orthopaedic cement (otherwise known as a cement spacer), which is used in two-stage joint revision typically to treat joint arthroplasty infection. It is filled with prepared antibiotic-containing bone cement which cures into the shape of the prosthesis and is subsequently placed into the joint space until replaced with a revision joint prosthesis. It is typically made of silicone and available in a variety of shapes and sizes for different joint applications. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
431529195
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08058964729163KeyFix_FILLER CANNULA FOR FENESTRATED SCREW 8-16 G9000302026-05-05
08058964729057Arthrex Bone Cement Closed Mixing Bowl AS-901-22024-10-14
08058964729064Arthrex Bone Cement Mixing Syringe AS-901-32024-10-14
08058964729071Arthrex Bone Cement Syringe Gun, DisposableAS-901-42024-10-14
08058964727862SpaceFlex Knee Trial9002012024-10-10
08058964728654Arthrex Bone Cement Mixing Syringe AR-901-32024-10-14
08058964728715Arthrex Bone Cement Open Mixing BowlAR-901-12024-10-14
08058964728753Arthrex Bone Cement Closed Mixing Bowl AR-901-22024-10-14
08058964728760Arthrex Bone Cement Syringe Gun, DisposableAR-901-42024-10-14
08058964729217CeMend Shoulder SpacerAR-902-08422025-12-19
08058964729224CeMend Shoulder SpacerAR-902-10422025-12-19
08058964729231CeMend Shoulder SpacerAR-902-10482025-12-19
08058964729248CeMend Shoulder SpacerAR-902-12482025-12-19
08058964729255CeMend Shoulder Spacer Reamer TrayAR-902-C12025-12-19
08058964729262Reamer T-handleAR-902-132025-12-19
08058964729279CeMend Reamer 8mmAR-902-142025-12-19
08058964729286CeMend Reamer 10mmAR-902-152025-12-19
08058964729293CeMend Reamer 12mmAR-902-162025-12-19
08058964729309CeMend Reamer 14mmAR-902-172025-12-19
08058964729385CeMend Shoulder Spacer Trial 08 42AR-902-202025-12-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
E31442100200SignatureMaterialise NVKWY2026-09-24
E31442100300SignatureMaterialise NVKWY2026-09-24
09348215199890Triple Taper Stem Standard Offset Collared Size 0SIGNATURE ORTHOPAEDICS PTY LTDKWL2026-09-22
09348215199890Triple Taper Stem Standard Offset Collared Size 0SIGNATURE ORTHOPAEDICS PTY LTDKWY2026-09-22
09348215199906Triple Taper Stem High Offset Collared Size 0SIGNATURE ORTHOPAEDICS PTY LTDKWL2026-09-22
09348215199906Triple Taper Stem High Offset Collared Size 0SIGNATURE ORTHOPAEDICS PTY LTDKWY2026-09-22
09348215199913Triple Taper Stem Standard Offset Collarless Size 0SIGNATURE ORTHOPAEDICS PTY LTDKWY2026-09-22
09348215199913Triple Taper Stem Standard Offset Collarless Size 0SIGNATURE ORTHOPAEDICS PTY LTDKWL2026-09-22
09348215199920Triple Taper Stem High Offset Collarless Size 0SIGNATURE ORTHOPAEDICS PTY LTDKWY2026-09-22
09348215199920Triple Taper Stem High Offset Collarless Size 0SIGNATURE ORTHOPAEDICS PTY LTDKWL2026-09-22
09348215199937Triple Taper Stem Standard Offset Collared Size 1SIGNATURE ORTHOPAEDICS PTY LTDKWL2026-09-22
09348215199937Triple Taper Stem Standard Offset Collared Size 1SIGNATURE ORTHOPAEDICS PTY LTDKWY2026-09-22
09348215199944Triple Taper Stem High Offset Collared Size 1SIGNATURE ORTHOPAEDICS PTY LTDKWY2026-09-22
09348215199944Triple Taper Stem High Offset Collared Size 1SIGNATURE ORTHOPAEDICS PTY LTDKWL2026-09-22
09348215199951Triple Taper Stem Standard Offset Collarless Size 1SIGNATURE ORTHOPAEDICS PTY LTDKWL2026-09-22
09348215199951Triple Taper Stem Standard Offset Collarless Size 1SIGNATURE ORTHOPAEDICS PTY LTDKWY2026-09-22
09348215199968Triple Taper Stem High Offset Collarless Size 1SIGNATURE ORTHOPAEDICS PTY LTDKWL2026-09-22
09348215199968Triple Taper Stem High Offset Collarless Size 1SIGNATURE ORTHOPAEDICS PTY LTDKWY2026-09-22
09348215199975Triple Taper Stem Standard Offset Collared Size 2SIGNATURE ORTHOPAEDICS PTY LTDKWY2026-09-22
09348215199975Triple Taper Stem Standard Offset Collared Size 2SIGNATURE ORTHOPAEDICS PTY LTDKWL2026-09-22
09348215199982Triple Taper Stem High Offset Collared Size 2SIGNATURE ORTHOPAEDICS PTY LTDKWY2026-09-22
09348215199982Triple Taper Stem High Offset Collared Size 2SIGNATURE ORTHOPAEDICS PTY LTDKWL2026-09-22
09348215199999Triple Taper Stem Standard Offset Collarless Size 2SIGNATURE ORTHOPAEDICS PTY LTDKWY2026-09-22
09348215199999Triple Taper Stem Standard Offset Collarless Size 2SIGNATURE ORTHOPAEDICS PTY LTDKWL2026-09-22
09363272000002Triple Taper Stem High Offset Collarless Size 2SIGNATURE ORTHOPAEDICS PTY LTDKWL2026-09-22
09363272000002Triple Taper Stem High Offset Collarless Size 2SIGNATURE ORTHOPAEDICS PTY LTDKWY2026-09-22
09363272000019Triple Taper Stem Standard Offset Collared Size 3SIGNATURE ORTHOPAEDICS PTY LTDKWY2026-09-22
09363272000019Triple Taper Stem Standard Offset Collared Size 3SIGNATURE ORTHOPAEDICS PTY LTDKWL2026-09-22
09363272000026Triple Taper Stem High Offset Collared Size 3SIGNATURE ORTHOPAEDICS PTY LTDKWY2026-09-22
09363272000026Triple Taper Stem High Offset Collared Size 3SIGNATURE ORTHOPAEDICS PTY LTDKWL2026-09-22