FDA.reportPublic FDA data

REMEDY Poly+Plus Acetabular Cup

Primary DI
00850011453520
Brand
REMEDY Poly+Plus Acetabular Cup
Company
OSTEOREMEDIES, LLC
Model
RHPAC46
Catalog number
RHPAC46
Device description
REMEDY® Poly+Plus Acetabular Cup – 46mm ID/ 54mm OD
Published
2026-06-01
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
KWLProsthesis, Hip, Hemi-, Femoral, Metal
KWYProsthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWLProsthesis, Hip, Hemi-, Femoral, MetalOrthopedic2
KWYProsthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or UncementedOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K253675000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K253675000OsteoRemedies Hip Spacer SystemOsteoremedies, LLC2025-12-23KWL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850011453520PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850011453520008500114535208500114535200850011453520

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic cement spacerA prefabricated device made of orthopaedic bone cement [e.g., polymethylmethacrylate (PMMA)], with an appropriate antibiotic, that is temporarily placed into a joint space to function as a carrier for the local delivery of antibiotic drugs and to prevent bone-on-bone contact and contraction of soft-tissue during surgical treatment of an infected joint. The shape and size of the device is modified to fit the joint space. This non-weight-bearing spacer remains in place until the infection clears; it is then removed and replaced with a conventional joint prosthesis. This is a single-use device.

Regulatory Flags#

DUNS number
079596704
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
true
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
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
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
00850011453391REMEDY Poly+Plus Tibial Spacer RTPTSM13RTPTSM132025-12-16
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
00193982895006TRIVANCEGLOBUS MEDICAL, INC.KWY2026-08-14
00193982895013TRIVANCEGLOBUS MEDICAL, INC.KWY2026-08-14
00193982895020TRIVANCEGLOBUS MEDICAL, INC.KWY2026-08-14
00193982895037TRIVANCEGLOBUS MEDICAL, INC.KWY2026-08-14
00193982895044TRIVANCEGLOBUS MEDICAL, INC.KWY2026-08-14
00193982895051TRIVANCEGLOBUS MEDICAL, INC.KWY2026-08-14
00193982895068TRIVANCEGLOBUS MEDICAL, INC.KWY2026-08-14
00193982895075TRIVANCEGLOBUS MEDICAL, INC.KWY2026-08-14
00193982895082TRIVANCEGLOBUS MEDICAL, INC.KWY2026-08-14
00193982895099TRIVANCEGLOBUS MEDICAL, INC.KWY2026-08-14
00193982895105TRIVANCEGLOBUS MEDICAL, INC.KWY2026-08-14
00193982895112TRIVANCEGLOBUS MEDICAL, INC.KWY2026-08-14
00193982895136TRIVANCEGLOBUS MEDICAL, INC.KWY2026-08-14
00193982895143TRIVANCEGLOBUS MEDICAL, INC.KWY2026-08-14
00193982895150TRIVANCEGLOBUS MEDICAL, INC.KWY2026-08-14
00193982895167TRIVANCEGLOBUS MEDICAL, INC.KWY2026-08-14
00193982895174TRIVANCEGLOBUS MEDICAL, INC.KWY2026-08-14
00193982895181TRIVANCEGLOBUS MEDICAL, INC.KWY2026-08-14
00193982895198TRIVANCEGLOBUS MEDICAL, INC.KWY2026-08-14
00193982895204TRIVANCEGLOBUS MEDICAL, INC.KWY2026-08-14
00193982895211TRIVANCEGLOBUS MEDICAL, INC.KWY2026-08-14
00193982895228TRIVANCEGLOBUS MEDICAL, INC.KWY2026-08-14
00193982895235TRIVANCEGLOBUS MEDICAL, INC.KWY2026-08-14
00193982895242TRIVANCEGLOBUS MEDICAL, INC.KWY2026-08-14
00193982895266TRIVANCEGLOBUS MEDICAL, INC.KWY2026-08-14
00193982895273TRIVANCEGLOBUS MEDICAL, INC.KWY2026-08-14
00193982895280TRIVANCEGLOBUS MEDICAL, INC.KWY2026-08-14
00193982895297TRIVANCEGLOBUS MEDICAL, INC.KWY2026-08-14
00193982895303TRIVANCEGLOBUS MEDICAL, INC.KWY2026-08-14
00193982895310TRIVANCEGLOBUS MEDICAL, INC.KWY2026-08-14