FDA.reportPublic FDA data

REMEDY Poly+Plus Tibial Spacer

Primary DI
00850011453391
Brand
REMEDY Poly+Plus Tibial Spacer
Company
OSTEOREMEDIES, LLC
Model
RTPTSM13
Catalog number
RTPTSM13
Device description
REMEDY® POLY+PLUS Tibial Trial SM 13 mm
Published
2025-12-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
00850011453391PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850011453391008500114533918500114533910850011453391

GMDN Terms#

Term, Definition table
TermDefinition
Knee tibia prosthesis trial, reusableA copy of a final tibia prosthesis designed to be used during unicompartmental knee replacement surgery or total knee arthroplasty (TKA) to determine the correct alignment, size, and fit of the final prosthesis. It is one of a set, or a set, of graduated sizes, and may be used in conjunction with a knee femur trial prosthesis and a patella trial prosthesis. It is typically made of metal or polymer material and includes tibial base plate trials, tibial spacer trials, tibial insert trials, tibial stem trials, tibial wedge/augment trials, and guide pin trials. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
079596704
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850011453476REMEDY CoCr Modular HeadsRHCCH40RHCCH402026-06-01
00850011453483REMEDY CoCr Modular HeadsRHCCH44RHCCH442026-06-01
00850011453490REMEDY CoCr Modular HeadsRHCCH46RHCCH462026-06-01
00850011453506REMEDY Poly+Plus Acetabular CupRHPAC40RHPAC402026-06-01
00850011453513REMEDY Poly+Plus Acetabular CupRHPAC44RHPAC442026-06-01
00850011453520REMEDY Poly+Plus Acetabular CupRHPAC46RHPAC462026-06-01
00850011453537Remedy Poly+Plus Acetabular CupRHACI38RHACI382026-06-01
00850011453544REMEDY CoCr Modular HeadsRRTHD44RRTHD442026-06-01
00850011453223BioBrushDDBK03DDBK032026-04-20
00850011453469InterSpaceIHBASEIHBASE2026-04-20
00855195006616Spectrum GVSPECTRUM40 2018-11-20
00850011453339REMEDY Poly+Plus Tibial Spacer RPPSM13RPPSM132025-12-16
00850011453346REMEDY Poly+Plus Tibial Spacer RPPSM17RPPSM172025-12-16
00850011453353REMEDY Poly+Plus Tibial Spacer RPPMD13RPPMD132025-12-16
00850011453360REMEDY Poly+Plus Tibial Spacer RPPMD17RPPMD172025-12-16
00850011453377REMEDY Poly+Plus Tibial Spacer RPPLG13RPPLG132025-12-16
00850011453384REMEDY Poly+Plus Tibial Spacer RPPLG17RPPLG172025-12-16
00850011453407REMEDY Poly+Plus Tibial Spacer RTPTSM17RTPTSM172025-12-16
00850011453414REMEDY Poly+Plus Tibial Spacer RTPTMD13RTPTMD132025-12-16
00850011453421REMEDY Poly+Plus Tibial Spacer RTPTMD17RTPTMD172025-12-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840286860147Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HWT2026-07-10
00840286860154Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HWT2026-07-10
00840286860161Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HWT2026-07-10
00840286860178Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HWT2026-07-10
00840286860185Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HWT2026-07-10
00840286860192Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HWT2026-07-10
00840286860208Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HWT2026-07-10
00840286860215Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HWT2026-07-10
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00840286860321Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HWT2026-07-10
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00840286860499Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HWT2026-07-10
00840286860512Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HWT2026-07-10
00840286860536Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HWT2026-07-10