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Data / Medical devices / United States / Osteoremedies, LLC

Osteoremedies, LLC: FDA-registered device maker in Memphis, TN, United States, 13 510(k) clearances

Osteoremedies, LLC is registered with the FDA (registration 3010537287) in Memphis, TN, United States. It lists 11 device types. The FDA files 13 510(k) clearances under its listings, the newest dated December 23, 2025. Registered through 2027. FDA data exported November 2, 2026.

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Get makers like this oneWatch Osteoremedies, LLC
FDA registration number
3010537287
Address
6800 Poplar Ave Ste 120, Memphis, TN, United States, 38138
Owner or operator
Osteoremedies, LLC (10045273)
Roles
Repackager or relabeler, Specification developer
First device listed
November 1, 2013
Registered through
2027
Brand names listed
BioBrush, Interspace GV Hip Trial, OsteoRemedies Remedy Trial Tray, REMEDY CoCr Modular Femoral Head, REMEDY Hip Spacer, REMEDY Knee Spacer, REMEDY POLY+PLUS Acetabular Cup, REMEDY Radel Trial and more

Devices it lists

DeviceProduct codeClassRoleSource
Bone CementLOD2Repackager or relabeler, Specification developeraccessdata.fda.gov
Bone Cement, AntibioticMBB2Repackager or relabeler, Specification developeraccessdata.fda.gov
Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/AttachmentHWE1Specification developeraccessdata.fda.gov
Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/PolymerKWZ2Specification developeraccessdata.fda.gov
Prosthesis, Hip, Hemi-, Femoral, MetalKWL2Specification developeraccessdata.fda.gov
Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or UncementedKWY2Specification developeraccessdata.fda.gov
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerJWH2Specification developeraccessdata.fda.gov
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer CementedKWS2Specification developeraccessdata.fda.gov
Pusher, SocketHXO1Specification developeraccessdata.fda.gov
TemplateHWT1Repackager or relabeler, Specification developeraccessdata.fda.gov
Tray, Surgical, InstrumentFSM1Specification developeraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
December 23, 2025K253675OsteoRemedies Hip Spacer SystemKWLSubstantially EquivalentOsteoremedies, LLCaccessdata.fda.gov
April 2, 2025K250760SPECTRUM GV Bone CementLODSubstantially EquivalentOsteoremedies, LLCaccessdata.fda.gov
October 2, 2024K242377REMEDY Stemmed Knee Spacer System with All-Poly Tibial ComponentJWHSubstantially EquivalentOsteoremedies, LLCaccessdata.fda.gov
December 20, 2023K231556SPECTRUM® GV Bone CementLODSubstantially EquivalentOsteoremedies, LLCaccessdata.fda.gov
January 5, 2023K223650REMEDY Stemmed Knee SpacerJWHSubstantially EquivalentOsteoremedies, LLCaccessdata.fda.gov
January 10, 2020K192995OsteoRemedies Hip Spacer SystemKWLSubstantially EquivalentOsteoremedies, LLCaccessdata.fda.gov
August 23, 2019K191981REMEDY Acetabular CupKWLSubstantially EquivalentOsteoremedies, LLCaccessdata.fda.gov
July 25, 2019K183017Remedy Femoral Component 84mm, Remedy Stemmed Knee SpacerJWHSubstantially EquivalentOsteoremedies, LLCaccessdata.fda.gov
August 29, 2018K172906REMEDY PLUS Hip Spacer, UNITE PLUS Bone CementKWLSubstantially EquivalentOsteoremedies, LLCaccessdata.fda.gov
February 22, 2018K173967Remedy Acetabular CupKWLSubstantially EquivalentOsteoremedies, LLCaccessdata.fda.gov
December 15, 2015K152267Remedy® Shoulder SpacerKWSSubstantially EquivalentOsteoremedies, LLCaccessdata.fda.gov
April 5, 2012K1124702GC HIP/KNEE MODULAR SPACERKWLSubstantially EquivalentMandell Horwitz Consultants, LLCaccessdata.fda.gov
November 24, 2009K092773CEMEX GENTA, GENTA SYSTEM AND GENTA SYSTEM FASTLODSubstantially EquivalentTecres S.P.A.accessdata.fda.gov

Compare with other makers

Updated December 23, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.