FDA.reportPublic FDA data

InterSpace® Knee Mold Tibial Component M

Primary DI
04260056886225
Brand
InterSpace® Knee Mold Tibial Component M
Company
OSARTIS GmbH
Model
04-0235
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
2026-10-28
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
04260056886225PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260056886225042600568862254260056886225

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
04260056886249InterSpace® Knee Mold Tibial Component L04-02402026-10-28
04260056881565ManuMix02-060102-06022021-10-12
04260056885624BonOs R 1x4001-01172015-09-25
04260056885679BonOs R Genta 1x4001-02172015-09-25
04260056885747Simplex HV6194-1-0016194-1-0102015-09-24
04260056885761Simplex HV with Gentamicin6195-1-0016195-1-0102015-09-24
04260056882579BonOs HV1x4001-01622024-05-17
04260056882623BonOs HV Genta1x4001-02622024-04-03
04260056881633EASYMIX® vacuum pump I02-040102-04012022-12-01
04260056881930EASYMIX® vacuum pump II02-020102-02012022-12-01
04260056881251EASYMIX cement injector02-0504-0402-0504-042022-11-28
04260056880759Vertecem II Cement Kit08.702.017S08.702.017S2015-10-21
04260056883231BonOs Inject01-03092015-10-02
04260056880636Bactisure00888700200008887002002026-08-25
04260056880667XPERIENCE Advanced Surgical Irrigation008875010000887510002026-07-28
04260056880650BLASTXMC-WG-0003-40MC-WG-0003-402026-07-12
04260056880674XPERIENCE Advanced Surgical IrrigationSL-0005MC-SL-0005-102026-04-01
04260056880643BLASTX®WG-0001MC-WG.0001-122026-02-19
14260056880640BLASTX®WG-0001MC-WG.0001-122026-02-19
04260056880612EASYMIX® Nozzle slim02-010402-01042022-12-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
05056139247804Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139247811Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139247828Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139247835Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139247941Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139247958Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139247965Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139247972Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139247989Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139248047Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139248054Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139248061Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139248078Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139248085Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139248146Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139248153Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139248160Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139248177Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139248184Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139248597Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139249013Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139249020Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139249037Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139249044Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139249303Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139249310Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139249327Unity Total Knee SystemCORIN LTDJWH2026-10-23