# Osteoremedies, LLC

- Location (FDA's records): Germantown, TN
- FDA decisions: 12 (2015–2026): 12 510(k) clearances
- Product codes: KWL (6), JWH (3), LOD (2), KWS (1)
- 510(k) review time since 2016: median 43 days, against 73 for FDA's reviews in the same codes and years (2 of 4 faster)
- Predicates its devices cite: 22 (15 its own); citations of its devices by later devices: 22 (15 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Mandell Horwitz Consultants, LLC: 4 (https://510kreport.com/company/mandell-horwitz-consultants)
- Tecres S.P.A.: 2 (https://510kreport.com/company/tecres)
- Cossington, Ltd.: 1 (https://510kreport.com/company/cossington)

## Firms that cite its devices most
- G21, S.R.L.: 2 (https://510kreport.com/company/g21)
- Tecres S.P.A.: 1 (https://510kreport.com/company/tecres)
- Osartis GmbH: 1 (https://510kreport.com/company/osartis)
- Heraeus Medical GmbH: 1 (https://510kreport.com/company/heraeus-medical)
- Signature Orthopaedics Pty, Ltd.: 1 (https://510kreport.com/company/signature-orthopaedics)
- Total Joint Orthopedics, Inc.: 1 (https://510kreport.com/company/total-joint-orthopedics)

## Its most-cited devices
- K172906: REMEDY PLUS Hip Spacer, UNITE PLUS Bone Cement (2018), cited by 6
- K183017: Remedy Femoral Component 84mm, Remedy Stemmed Knee Spacer (2019), cited by 4
- K173967: Remedy Acetabular Cup (2018), cited by 3
- K191981: REMEDY Acetabular Cup (2019), cited by 3
- K152267: Remedy® Shoulder Spacer (2015), cited by 2
- K192995: OsteoRemedies Hip Spacer System (2020), cited by 1

## Recent decisions
- K262290: REMEDY POLY+PLUS SNAP FIT Acetabular Cup (Jul 24, 2026)
- K253675: OsteoRemedies Hip Spacer System (Dec 23, 2025)
- K250760: SPECTRUM GV Bone Cement (Apr 2, 2025)
- K242377: REMEDY Stemmed Knee Spacer System with All-Poly Tibial Component (Oct 2, 2024)
- K231556: SPECTRUM® GV Bone Cement (Dec 20, 2023)
- K223650: REMEDY Stemmed Knee Spacer (Jan 5, 2023)
- K192995: OsteoRemedies Hip Spacer System (Jan 10, 2020)
- K191981: REMEDY Acetabular Cup (Aug 23, 2019)

Source page: https://510kreport.com/company/osteoremedies