510(k) Report

FDA applicant

Osteoremedies, LLC

Germantown, TN12 decisions2015–20260 recalls

FDA records 12 decisions for Osteoremedies, LLC (Germantown, TN) from 2015 to 2026: 12 510(k) clearances. Most are in product codes KWL (Prosthesis, Hip, Hemi-, Femoral, Metal) and JWH (Prosthesis, Knee, Patellofemorotibial…). Since 2016 its 510(k)s took a median of 43 days from receipt to decision, against 73 for FDA’s reviews in the same codes and years. Its devices cite 22 predicates, 15 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, orthopedic panel, where it files most

How often FDA has decided Osteoremedies, LLC’s devices, and how often a recall has named them.

FDA decisions per year

2in 2025

2015: 12018: 22019: 22020: 12023: 22024: 12025: 22026 (partial year): 1
2015high 2 (2018) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2015.

FIG. 1 — Osteoremedies, LLC by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Osteoremedies, LLC’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • KWLProsthesis, Hip, Hemi-, Femoral, Metal6decisions
  • JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer3decisions
  • LODBone Cement2decisions
  • KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented1decision

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 43 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 73 days; 2 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 22 predicates; 15 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 22 times; 15 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K172906REMEDY PLUS Hip Spacer, UNITE PLUS Bone CementOsteoremedies, LLC · 20186cite it
  • K183017Remedy Femoral Component 84mm, Remedy Stemmed Knee SpacerOsteoremedies, LLC · 20194cite it
  • K173967Remedy Acetabular CupOsteoremedies, LLC · 20183cite it
  • K191981REMEDY Acetabular CupOsteoremedies, LLC · 20193cite it
  • K152267Remedy® Shoulder SpacerOsteoremedies, LLC · 20152cite it
  • K192995OsteoRemedies Hip Spacer SystemOsteoremedies, LLC · 20201cites it

What has FDA decided for it lately?

  • K262290REMEDY POLY+PLUS SNAP FIT Acetabular CupOsteoremedies, LLC · 2026
  • K253675OsteoRemedies Hip Spacer SystemOsteoremedies, LLC · 2025
  • K250760SPECTRUM GV Bone CementOsteoremedies, LLC · 2025
  • K242377REMEDY Stemmed Knee Spacer System with All-Poly Tibial ComponentOsteoremedies, LLC · 2024
  • K231556SPECTRUM® GV Bone CementOsteoremedies, LLC · 2023
  • K223650REMEDY Stemmed Knee SpacerOsteoremedies, LLC · 2023
  • K192995OsteoRemedies Hip Spacer SystemOsteoremedies, LLC · 2020
  • K191981REMEDY Acetabular CupOsteoremedies, LLC · 2019

All 12 as Osteoremedies, LLC →