FDA.reportPublic FDA data

REMEDY Poly+Plus Tibial Spacer

Primary DI
00850011453377
Brand
REMEDY Poly+Plus Tibial Spacer
Company
OSTEOREMEDIES, LLC
Model
RPPLG13
Catalog number
RPPLG13
Device description
REMEDY® POLY+PLUS Tibial Comp. LG 13mm
Published
2025-12-16
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
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K242377000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K242377000REMEDY Stemmed Knee Spacer System with All-Poly Tibial ComponentOsteoremedies, LLC2024-10-02JWH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850011453377PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850011453377008500114533778500114533770850011453377

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
079596704
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00855195006241Unite CementUNITE402016-01-20
00855195006494Remedy SpacerUNITE402016-04-06
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
00850011453384REMEDY Poly+Plus Tibial Spacer RPPLG17RPPLG172025-12-16
00850011453391REMEDY Poly+Plus Tibial Spacer RTPTSM13RTPTSM132025-12-16
00850011453407REMEDY Poly+Plus Tibial Spacer RTPTSM17RTPTSM172025-12-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00192629475007EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475014EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475021EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475038EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475045EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475052EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475069EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475076EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475083EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475090EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475106EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475113EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475120EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475137EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475144EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475151EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475168EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475175EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475182EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475199EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475205EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475212EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475229EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475236EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475243EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475250EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475267EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475274EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475281EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475298EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03