FDA.reportPublic FDA data

REMEDY CoCr Modular Heads

Primary DI
00850011453483
Brand
REMEDY CoCr Modular Heads
Company
OSTEOREMEDIES, LLC
Model
RHCCH44
Catalog number
RHCCH44
Device description
REMEDY® CoCr Modular Femoral Head - 44 mm
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
00850011453483PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850011453483008500114534838500114534830850011453483

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
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
00850011453421REMEDY Poly+Plus Tibial Spacer RTPTMD17RTPTMD172025-12-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
E31442100200SignatureMaterialise NVKWY2026-09-24
E31442100300SignatureMaterialise NVKWY2026-09-24
09348215199890Triple Taper Stem Standard Offset Collared Size 0SIGNATURE ORTHOPAEDICS PTY LTDKWL2026-09-22
09348215199890Triple Taper Stem Standard Offset Collared Size 0SIGNATURE ORTHOPAEDICS PTY LTDKWY2026-09-22
09348215199906Triple Taper Stem High Offset Collared Size 0SIGNATURE ORTHOPAEDICS PTY LTDKWL2026-09-22
09348215199906Triple Taper Stem High Offset Collared Size 0SIGNATURE ORTHOPAEDICS PTY LTDKWY2026-09-22
09348215199913Triple Taper Stem Standard Offset Collarless Size 0SIGNATURE ORTHOPAEDICS PTY LTDKWY2026-09-22
09348215199913Triple Taper Stem Standard Offset Collarless Size 0SIGNATURE ORTHOPAEDICS PTY LTDKWL2026-09-22
09348215199920Triple Taper Stem High Offset Collarless Size 0SIGNATURE ORTHOPAEDICS PTY LTDKWY2026-09-22
09348215199920Triple Taper Stem High Offset Collarless Size 0SIGNATURE ORTHOPAEDICS PTY LTDKWL2026-09-22
09348215199937Triple Taper Stem Standard Offset Collared Size 1SIGNATURE ORTHOPAEDICS PTY LTDKWL2026-09-22
09348215199937Triple Taper Stem Standard Offset Collared Size 1SIGNATURE ORTHOPAEDICS PTY LTDKWY2026-09-22
09348215199944Triple Taper Stem High Offset Collared Size 1SIGNATURE ORTHOPAEDICS PTY LTDKWY2026-09-22
09348215199944Triple Taper Stem High Offset Collared Size 1SIGNATURE ORTHOPAEDICS PTY LTDKWL2026-09-22
09348215199951Triple Taper Stem Standard Offset Collarless Size 1SIGNATURE ORTHOPAEDICS PTY LTDKWL2026-09-22
09348215199951Triple Taper Stem Standard Offset Collarless Size 1SIGNATURE ORTHOPAEDICS PTY LTDKWY2026-09-22
09348215199968Triple Taper Stem High Offset Collarless Size 1SIGNATURE ORTHOPAEDICS PTY LTDKWL2026-09-22
09348215199968Triple Taper Stem High Offset Collarless Size 1SIGNATURE ORTHOPAEDICS PTY LTDKWY2026-09-22
09348215199975Triple Taper Stem Standard Offset Collared Size 2SIGNATURE ORTHOPAEDICS PTY LTDKWY2026-09-22
09348215199975Triple Taper Stem Standard Offset Collared Size 2SIGNATURE ORTHOPAEDICS PTY LTDKWL2026-09-22
09348215199982Triple Taper Stem High Offset Collared Size 2SIGNATURE ORTHOPAEDICS PTY LTDKWY2026-09-22
09348215199982Triple Taper Stem High Offset Collared Size 2SIGNATURE ORTHOPAEDICS PTY LTDKWL2026-09-22
09348215199999Triple Taper Stem Standard Offset Collarless Size 2SIGNATURE ORTHOPAEDICS PTY LTDKWY2026-09-22
09348215199999Triple Taper Stem Standard Offset Collarless Size 2SIGNATURE ORTHOPAEDICS PTY LTDKWL2026-09-22
09363272000002Triple Taper Stem High Offset Collarless Size 2SIGNATURE ORTHOPAEDICS PTY LTDKWL2026-09-22
09363272000002Triple Taper Stem High Offset Collarless Size 2SIGNATURE ORTHOPAEDICS PTY LTDKWY2026-09-22
09363272000019Triple Taper Stem Standard Offset Collared Size 3SIGNATURE ORTHOPAEDICS PTY LTDKWY2026-09-22
09363272000019Triple Taper Stem Standard Offset Collared Size 3SIGNATURE ORTHOPAEDICS PTY LTDKWL2026-09-22
09363272000026Triple Taper Stem High Offset Collared Size 3SIGNATURE ORTHOPAEDICS PTY LTDKWY2026-09-22
09363272000026Triple Taper Stem High Offset Collared Size 3SIGNATURE ORTHOPAEDICS PTY LTDKWL2026-09-22