FDA.reportPublic FDA data

Interspace GV Hip Spacer 60

Primary DI
08031497003979
Brand
Interspace GV Hip Spacer 60
Company
TECRES SPA
Model
IHGV60S
Device description
TAPERED WEDGE STEM
Published
2026-02-11
Public version status
New
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
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
K252326000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K252326000InterSpace GV Hip SpacerTecres S.P.A.2025-08-06KWL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08031497003979PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08031497003979080314970039798031497003979

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic cement spacerA prefabricated device made of orthopaedic bone cement [e.g., polymethylmethacrylate (PMMA)], with an appropriate antibiotic, that is temporarily placed into a joint space to function as a carrier for the local delivery of antibiotic drugs and to prevent bone-on-bone contact and contraction of soft-tissue during surgical treatment of an infected joint. The shape and size of the device is modified to fit the joint space. This non-weight-bearing spacer remains in place until the infection clears; it is then removed and replaced with a conventional joint prosthesis. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length96Millimeter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
435428396
Device count
1
Combination product
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
28031497000101Mendec Spine12302015-10-06
08031497003894InterSpace Hip Trial, 46mm ShortIHT46S2026-02-11
08031497003900InterSpace Hip Trial, 54mm ShortIHT54S2026-02-11
08031497003917InterSpace Hip Trial, 60mm ShortIHT60S2026-02-11
08031497003924InterSpace Hip Trial, 46mm Long IHT46L2026-02-11
08031497003931InterSpace Hip Trial, 54mm LongIHT54L2026-02-11
08031497003948InterSpace Hip Trial, 60mm LongIHT60L2026-02-11
08031497003955Interspace GV Hip Spacer 46IHGV46S2026-02-11
08031497003962Interspace GV Hip Spacer 54IHGV54S2026-02-11
08031497003986Interspace GV Hip Spacer 46 XLIHGV46L2026-02-11
08031497003993Interspace GV Hip Spacer 54 XLIHGV54L2026-02-11
08031497004006Interspace GV Hip Spacer 60 XLIHGV60L2026-02-11
08031497002347InterSpace Knee TrialSPK90Z12022-09-23
08031497002897InterSpace Knee ATS Trial KitSPK90Z22022-09-23
08031497002903InterSpace Knee Trial XLSPK03Z12022-09-23
08031497003689Mendec® Kypho Set Monolateral 10 mmASB030A2025-12-17
08031497003696Mendec® Kypho Set Monolateral 15 mmASB030B2025-12-17
08031497003702Mendec® Kypho Set Monolateral 20 mmASB030C2025-12-17
08031497003801Mendec® Kypho Set Bilateral 10 mmASB032A2025-12-17
08031497003818Mendec® Kypho Set Bilateral 15 mmASB032B2025-12-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850011453476REMEDY CoCr Modular HeadsOSTEOREMEDIES, LLCKWY2026-06-01
00850011453476REMEDY CoCr Modular HeadsOSTEOREMEDIES, LLCKWL2026-06-01
00850011453483REMEDY CoCr Modular HeadsOSTEOREMEDIES, LLCKWL2026-06-01
00850011453483REMEDY CoCr Modular HeadsOSTEOREMEDIES, LLCKWY2026-06-01
00850011453490REMEDY CoCr Modular HeadsOSTEOREMEDIES, LLCKWL2026-06-01
00850011453490REMEDY CoCr Modular HeadsOSTEOREMEDIES, LLCKWY2026-06-01
00850011453506REMEDY Poly+Plus Acetabular CupOSTEOREMEDIES, LLCKWY2026-06-01
00850011453506REMEDY Poly+Plus Acetabular CupOSTEOREMEDIES, LLCKWL2026-06-01
00850011453513REMEDY Poly+Plus Acetabular CupOSTEOREMEDIES, LLCKWY2026-06-01
00850011453513REMEDY Poly+Plus Acetabular CupOSTEOREMEDIES, LLCKWL2026-06-01
00850011453520REMEDY Poly+Plus Acetabular CupOSTEOREMEDIES, LLCKWY2026-06-01
00850011453520REMEDY Poly+Plus Acetabular CupOSTEOREMEDIES, LLCKWL2026-06-01
07611996118674POLARSTEMSmith & Nephew, Inc.KWY2017-01-12
07611996142327POLARSTEMSmith & Nephew, Inc.KWY2017-01-12
07611996142334POLARSTEMSmith & Nephew, Inc.KWY2017-01-12
07611996142341POLARSTEMSmith & Nephew, Inc.KWY2017-01-12
07611996142358POLARSTEMSmith & Nephew, Inc.KWY2017-01-12
07611996142365POLARSTEMSmith & Nephew, Inc.KWY2017-01-12
07611996142372POLARSTEMSmith & Nephew, Inc.KWY2017-01-12
07611996142389POLARSTEMSmith & Nephew, Inc.KWY2017-01-12
07611996074901SL-PLUSSmith & Nephew, Inc.KWY2016-08-19
07611996074918SL-PLUSSmith & Nephew, Inc.KWY2016-08-19
07611996074925SL-PLUSSmith & Nephew, Inc.KWY2016-08-19
07611996074932SL-PLUSSmith & Nephew, Inc.KWY2016-08-19
07611996074949SL-PLUSSmith & Nephew, Inc.KWY2016-08-19
07611996074956SL-PLUSSmith & Nephew, Inc.KWY2016-08-19
07611996074963SL-PLUSSmith & Nephew, Inc.KWY2016-08-19
07611996074987SL-PLUSSmith & Nephew, Inc.KWY2016-08-19
07611996074994SL-PLUSSmith & Nephew, Inc.KWY2016-08-19
07611996075014SL-PLUSSmith & Nephew, Inc.KWY2016-08-19