FDA.reportPublic FDA data

InterSpace® Knee Mold Tibial Component XS

Primary DI
04260056886188
Brand
InterSpace® Knee Mold Tibial Component XS
Company
OSARTIS GmbH
Model
04-0225
Device description
The InterSpace® Knee Molds are single-use sterile molds used for molding of a temporary total knee spacer from acrylic bone cement in a two-stage septic revision arthroplasty of the knee joint. InterSpace® Knee Molds are a modular comprising of two separate molds one for the femoral and one for the tibial component. The InterSpace® Knee Mold Tibial Components are modular systems of base molds and inlays that allow the combination of different tibial stem and plateau sizes.
Published
2026-10-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
MBBBone Cement, Antibiotic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerOrthopedic2
MBBBone Cement, AntibioticOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K240856000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K240856000Hip Spacer Molds; Knee Spacer Molds; Shoulder Spacer MoldsOsartis GmbH2024-11-20MBB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260056886188PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260056886188042600568861884260056886188

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.

Device Sizes#

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

Regulatory Flags#

DUNS number
344261631
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04260056885860InterSpace® Hip Mold Short Stem04-01002026-10-29
04260056885877InterSpace® Hip Mold Trial Short Stem04-01012026-10-29
04260056885884InterSpace® Hip Mold Short Stem04-01052026-10-29
04260056885891InterSpace® Hip Mold Trial Short Stem04-01062026-10-29
04260056885907InterSpace® Hip Mold Short Stem04-01102026-10-29
04260056885914InterSpace® Hip Mold Trial Short Stem04-01112026-10-29
04260056885921InterSpace® Hip Mold Long Stem04-01152026-10-29
04260056885938InterSpace® Hip Mold Trial Long Stem04-01162026-10-29
04260056885945InterSpace® Hip Mold Long Stem04-01202026-10-29
04260056885952InterSpace® Hip Mold Trial Long Stem04-01212026-10-29
04260056885969InterSpace® Hip Mold Long Stem04-01252026-10-29
04260056885976InterSpace® Hip Mold Trial Long Stem04-01262026-10-29
04260056885983InterSpace® Hip Mold Head04-01302026-10-29
04260056885990InterSpace® Hip Mold Trial Head 42 mm04-01312026-10-29
04260056886003InterSpace® Hip Mold Head04-01352026-10-29
04260056886010InterSpace® Hip Mold Trial Head 48 mm04-01362026-10-29
04260056886027InterSpace® Hip Mold Head04-01402026-10-29
04260056886034InterSpace® Hip Mold Trial Head 52 mm04-01412026-10-29
04260056886041InterSpace® Hip Mold Head04-01452026-10-29
04260056886058InterSpace® Hip Mold Trial Head 56 mm04-01462026-10-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04260056885860InterSpace® Hip Mold Short StemOSARTIS GmbHMBB2026-10-29
04260056885884InterSpace® Hip Mold Short StemOSARTIS GmbHMBB2026-10-29
04260056885907InterSpace® Hip Mold Short StemOSARTIS GmbHMBB2026-10-29
04260056885921InterSpace® Hip Mold Long StemOSARTIS GmbHMBB2026-10-29
04260056885945InterSpace® Hip Mold Long StemOSARTIS GmbHMBB2026-10-29
04260056885969InterSpace® Hip Mold Long StemOSARTIS GmbHMBB2026-10-29
04260056885983InterSpace® Hip Mold HeadOSARTIS GmbHMBB2026-10-29
04260056886003InterSpace® Hip Mold HeadOSARTIS GmbHMBB2026-10-29
04260056886027InterSpace® Hip Mold HeadOSARTIS GmbHMBB2026-10-29
04260056886041InterSpace® Hip Mold HeadOSARTIS GmbHMBB2026-10-29
04260056886065InterSpace® Hip Mold HeadOSARTIS GmbHMBB2026-10-29
04260056886089InterSpace® Knee Mold Femoral Component XSOSARTIS GmbHMBB2026-10-29
04260056886089InterSpace® Knee Mold Femoral Component XSOSARTIS GmbHJWH2026-10-29
04260056886102InterSpace® Knee Mold Femoral Component SOSARTIS GmbHMBB2026-10-29
04260056886102InterSpace® Knee Mold Femoral Component SOSARTIS GmbHJWH2026-10-29
04260056886126InterSpace® Knee Mold Femoral Component MOSARTIS GmbHMBB2026-10-29
04260056886126InterSpace® Knee Mold Femoral Component MOSARTIS GmbHJWH2026-10-29
04260056886140InterSpace® Knee Mold Femoral Component LOSARTIS GmbHMBB2026-10-29
04260056886140InterSpace® Knee Mold Femoral Component LOSARTIS GmbHJWH2026-10-29
04260056886164InterSpace® Knee Mold Femoral Component XLOSARTIS GmbHJWH2026-10-29
04260056886164InterSpace® Knee Mold Femoral Component XLOSARTIS GmbHMBB2026-10-29
04260056886201InterSpace® Knee Mold Tibial Component SOSARTIS GmbHJWH2026-10-29
04260056886201InterSpace® Knee Mold Tibial Component SOSARTIS GmbHMBB2026-10-29
04260056886263InterSpace® Knee Mold Tibial Component XLOSARTIS GmbHJWH2026-10-29
04260056886263InterSpace® Knee Mold Tibial Component XLOSARTIS GmbHMBB2026-10-29
04260056886225InterSpace® Knee Mold Tibial Component MOSARTIS GmbHJWH2026-10-28
04260056886225InterSpace® Knee Mold Tibial Component MOSARTIS GmbHMBB2026-10-28
04260056886249InterSpace® Knee Mold Tibial Component LOSARTIS GmbHJWH2026-10-28
04260056886249InterSpace® Knee Mold Tibial Component LOSARTIS GmbHMBB2026-10-28
05056139247750Unity Total Knee SystemCORIN LTDJWH2026-10-23