FDA.reportPublic FDA data

Remedy Spacer

Primary DI
00855195006265
Brand
Remedy Spacer
Company
OSTEOREMEDIES, LLC
Model
RHHDMD
Device description
Remedy Modular Head 54mm
Published
2016-04-06
Public version status
Update
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
KWLProsthesis, Hip, Hemi-, Femoral, Metal
KWYProsthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
MBBBone Cement, Antibiotic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWLProsthesis, Hip, Hemi-, Femoral, MetalOrthopedic2
KWYProsthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or UncementedOrthopedic2
MBBBone Cement, AntibioticOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K112470000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K1124700002GC HIP/KNEE MODULAR SPACERMandell Horwitz Consultants, LLC2012-04-05KWL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00855195006265PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00855195006265008551950062658551950062650855195006265

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
079596704
Device count
1
Combination product
true
Lot or batch
true
Expiration date on label
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
00850011453391REMEDY Poly+Plus Tibial Spacer RTPTSM13RTPTSM132025-12-16
00850011453407REMEDY Poly+Plus Tibial Spacer RTPTSM17RTPTSM172025-12-16
00850011453414REMEDY Poly+Plus Tibial Spacer RTPTMD13RTPTMD132025-12-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850011453476REMEDY CoCr Modular HeadsOSTEOREMEDIES, LLCKWY2026-06-01
00850011453476REMEDY CoCr Modular HeadsOSTEOREMEDIES, LLCKWL2026-06-01
00850011453483REMEDY CoCr Modular HeadsOSTEOREMEDIES, LLCKWL2026-06-01
00850011453483REMEDY CoCr Modular HeadsOSTEOREMEDIES, LLCKWY2026-06-01
00850011453490REMEDY CoCr Modular HeadsOSTEOREMEDIES, LLCKWL2026-06-01
00850011453490REMEDY CoCr Modular HeadsOSTEOREMEDIES, LLCKWY2026-06-01
00850011453506REMEDY Poly+Plus Acetabular CupOSTEOREMEDIES, LLCKWY2026-06-01
00850011453506REMEDY Poly+Plus Acetabular CupOSTEOREMEDIES, LLCKWL2026-06-01
00850011453513REMEDY Poly+Plus Acetabular CupOSTEOREMEDIES, LLCKWY2026-06-01
00850011453513REMEDY Poly+Plus Acetabular CupOSTEOREMEDIES, LLCKWL2026-06-01
00850011453520REMEDY Poly+Plus Acetabular CupOSTEOREMEDIES, LLCKWY2026-06-01
00850011453520REMEDY Poly+Plus Acetabular CupOSTEOREMEDIES, LLCKWL2026-06-01
07611996118674POLARSTEMSmith & Nephew, Inc.KWY2017-01-12
07611996142327POLARSTEMSmith & Nephew, Inc.KWY2017-01-12
07611996142334POLARSTEMSmith & Nephew, Inc.KWY2017-01-12
07611996142341POLARSTEMSmith & Nephew, Inc.KWY2017-01-12
07611996142358POLARSTEMSmith & Nephew, Inc.KWY2017-01-12
07611996142365POLARSTEMSmith & Nephew, Inc.KWY2017-01-12
07611996142372POLARSTEMSmith & Nephew, Inc.KWY2017-01-12
07611996142389POLARSTEMSmith & Nephew, Inc.KWY2017-01-12
07611996074901SL-PLUSSmith & Nephew, Inc.KWY2016-08-19
07611996074918SL-PLUSSmith & Nephew, Inc.KWY2016-08-19
07611996074925SL-PLUSSmith & Nephew, Inc.KWY2016-08-19
07611996074932SL-PLUSSmith & Nephew, Inc.KWY2016-08-19
07611996074949SL-PLUSSmith & Nephew, Inc.KWY2016-08-19
07611996074956SL-PLUSSmith & Nephew, Inc.KWY2016-08-19
07611996074963SL-PLUSSmith & Nephew, Inc.KWY2016-08-19
07611996074987SL-PLUSSmith & Nephew, Inc.KWY2016-08-19
07611996074994SL-PLUSSmith & Nephew, Inc.KWY2016-08-19
07611996075014SL-PLUSSmith & Nephew, Inc.KWY2016-08-19