# K173967: Remedy Acetabular Cup

- Pathway: 510(k) (Traditional)
- Applicant: Osteoremedies, LLC
- Decided: Feb 22, 2018 after 55 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: 6 generations back to K936159 (1995). 14 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 20 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 5.

## Most influential descendants
- K191981: REMEDY Acetabular Cup (2019), 4 descendants of its own
- 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, and where gentamicin is the most appropriate antibiotic based on the susceptibility pattern of the infecting micro-organism(s). 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 REMEDY® Hip Spacer using REMEDY® Modular Head 46 mm. 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/K173967
Methodology: https://510kreport.com/methodology