FDA.reportPublic FDA data

InterSpace® Knee Mold Trial Tibial Stem

Primary DI
04260056886287
Brand
InterSpace® Knee Mold Trial Tibial Stem
Company
OSARTIS GmbH
Model
04-0247
Device description
The InterSpace® Knee Mold Trial Femoral Components and InterSpace® Knee Mold Trial Tibial Components are modular reusable surgical tools for estimation of suitable spacer dimensions for use as interim prosthesis molded from bone cement with InterSpace® Knee Molds, in a two-stage septic revision arthroplasty of femoral and tibial knee.
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
false
Single use
false

Product Codes#

Code, Name table
CodeName
HWTTemplate

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWTTemplateOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260056886287PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260056886287042600568862874260056886287

GMDN Terms#

Term, Definition table
TermDefinition
Surgical implant template, reusableA device designed to determine the appropriate size and placement of a non-dental implant for a patient prior to or during implantation surgery. It is typically available as a graduated set or an individual plate (e.g., a translucent plastic sheet or a cut metal shape) with patterns/sizes corresponding to the size of the implant to be used to aid the surgeon in final selection of implant size, placement, and/or adaption. It is used for, e.g., total- or partial-joint prostheses, bone fracture fixation implants (plates, nails, including skull plate implants) or other types of surgical implants. This is a reusable device.

Device Sizes#

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

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

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

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
04260056885877InterSpace® Hip Mold Trial Short StemOSARTIS GmbHHWT2026-10-29
04260056885891InterSpace® Hip Mold Trial Short StemOSARTIS GmbHHWT2026-10-29
04260056885914InterSpace® Hip Mold Trial Short StemOSARTIS GmbHHWT2026-10-29
04260056885938InterSpace® Hip Mold Trial Long StemOSARTIS GmbHHWT2026-10-29
04260056885952InterSpace® Hip Mold Trial Long StemOSARTIS GmbHHWT2026-10-29
04260056885976InterSpace® Hip Mold Trial Long StemOSARTIS GmbHHWT2026-10-29
04260056885990InterSpace® Hip Mold Trial Head 42 mmOSARTIS GmbHHWT2026-10-29
04260056886010InterSpace® Hip Mold Trial Head 48 mmOSARTIS GmbHHWT2026-10-29
04260056886034InterSpace® Hip Mold Trial Head 52 mmOSARTIS GmbHHWT2026-10-29
04260056886058InterSpace® Hip Mold Trial Head 56 mmOSARTIS GmbHHWT2026-10-29
04260056886072InterSpace® Hip Mold Trial Head 60 mmOSARTIS GmbHHWT2026-10-29
04260056886096InterSpace® Knee Mold Trial Femoral Component XSOSARTIS GmbHHWT2026-10-29
04260056886119InterSpace® Knee Mold Trial Femoral Component SOSARTIS GmbHHWT2026-10-29
04260056886133InterSpace® Knee Mold Trial Femoral Component MOSARTIS GmbHHWT2026-10-29
04260056886157InterSpace® Knee Mold Trial Femoral Component LOSARTIS GmbHHWT2026-10-29
04260056886171InterSpace® Knee Mold Trial Femoral Component XLOSARTIS GmbHHWT2026-10-29
04260056886195InterSpace® Knee Mold Trial Tibial Component XSOSARTIS GmbHHWT2026-10-29
04260056886218InterSpace® Knee Mold Trial Tibial Component SOSARTIS GmbHHWT2026-10-29
04260056886232InterSpace® Knee Mold Trial Tibial Component MOSARTIS GmbHHWT2026-10-29
04260056886256InterSpace® Knee Mold Trial Tibial Component LOSARTIS GmbHHWT2026-10-29
04260056886270InterSpace® Knee Mold Trial Tibial Component XLOSARTIS GmbHHWT2026-10-29
04260056886416InterSpace® Knee Mold Trial Tibial InsertOSARTIS GmbHHWT2026-10-29
04260056886423InterSpace® Knee Mold Trial Tibial Stemmed InsertOSARTIS GmbHHWT2026-10-29
00889024702493OsseoFitZimmer, Inc.HWT2026-10-27
00889024702509OsseoFitZimmer, Inc.HWT2026-10-27
00889024702516OsseoFitZimmer, Inc.HWT2026-10-27
00889024702561OsseoFitZimmer, Inc.HWT2026-10-27
00889024702578OsseoFitZimmer, Inc.HWT2026-10-27
00889024702585OsseoFitZimmer, Inc.HWT2026-10-27
00889024702592OsseoFitZimmer, Inc.HWT2026-10-27