# K192995: OsteoRemedies Hip Spacer System

- Pathway: 510(k) (Special)
- Applicant: Osteoremedies, LLC
- Decided: Jan 10, 2020 after 77 days
- Product code: KWL (Prosthesis, Hip, Hemi-, Femoral, Metal)
- Device class: 2
- Regulation: 21 CFR 888.3360
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K936159 (1995). 22 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112470: 2GC Hip/Knee Modular Spacer, Mandell Horwitz Consultants, LLC (2012) Summary page 4.
- K172906: REMEDY PLUS Hip Spacer, UNITE PLUS Bone Cement, Osteoremedies, LLC (2018) Summary page 4.
- K191981: REMEDY Acetabular Cup, Osteoremedies, LLC (2019) Summary page 4.
- K173967: Remedy Acetabular Cup, Osteoremedies, LLC (2018) Summary page 4.

## Most influential descendants
- K253675: OsteoRemedies Hip Spacer System (2025), 1 descendant of its own
- K262290: REMEDY POLY+PLUS SNAP FIT Acetabular Cup (2026), 0 descendants of its own

## Indications for use
The OsteoRemedies Hip Spacer System consists of modular heads and stems, and optional acetabular cups. The REMEDY components of the OsteoRemedies Hip Spacer System include gentamicin and the REMEDY SPECTRUM GV components include gentamicin and vancomycin. The OsteoRemedies Hip Spacer System is indicated for temporary use (maximum 180 days) as an adjunct to total hip replacement (THR) in skeletally mature patients undergoing a two-stage procedure due to a septic process and where gentamicin or gentamicin/vancomycin are the most appropriate antibiotics based on the susceptibility pattern of the infecting micro-organism(s). Following removal of the existing femoral and acetabular components and radical debridement, the head and stem components are inserted into the femoral medullary canal and can mate directly with the native acetabulum or an acetabular component which is placed in the acetabular cavity. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection). The OsteoRemedies Hip Spacer System is not intended for use for more than 180 days, at which time all components must be explanted, and a permanent device implanted or another appropriate treatment performed (e.g., resection arthroplasty, fusion, etc.).

Source page: https://510kreport.com/device/K192995
Methodology: https://510kreport.com/methodology