# K191981: REMEDY Acetabular Cup

- Pathway: 510(k) (Special)
- Applicant: Osteoremedies, LLC
- Decided: Aug 23, 2019 after 30 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: 7 generations back to K936159 (1995). 21 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173967: Remedy Acetabular Cup, Osteoremedies, LLC (2018) Summary page 4.
- K172906: REMEDY PLUS Hip Spacer, UNITE PLUS Bone Cement, Osteoremedies, LLC (2018) Summary page 4.

## Most influential descendants
- K192995: OsteoRemedies Hip Spacer System (2020), 2 descendants of its own
- 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
- K223441: SpaceFlex Acetabular Cup (2023), 0 descendants of its own

## Indications for use
The REMEDY Acetabular Cup 46mm ID/54mm OD consists of an acetabular cup that 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. The REMEDY Acetabular Cup 46mm ID/54mm OD is positioned into the acetabular cavity following removal of the existing acetabular and femoral components and radical debridement. The device must be combined with the REMEDY Hip Spacer using the REMEDY 46mm Modular Head when gentamicin is the most appropriate antibiotic based on the susceptibility pattern of the infecting micro-organism(s), or the REMEDY SPECTRUM GV Hip Spacer using the REMEDY SPECTRUM GV 46mm Modular Head when gentamicin and vancomycin are the most appropriate antibiotic based on the susceptibility pattern of the infecting micro-organism(s). The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection). The REMEDY Acetabular Cup 46mm ID/54mm OD is not intended for use for more than 180 days, at which time it must be explanted and a permanent device implanted or another appropriate treatment performed (e.g., resection arthroplasty, etc.).

Source page: https://510kreport.com/device/K191981
Methodology: https://510kreport.com/methodology