# K172906: REMEDY PLUS Hip Spacer, UNITE PLUS Bone Cement

- Pathway: 510(k) (Traditional)
- Applicant: Osteoremedies, LLC
- Decided: Aug 29, 2018 after 341 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: 5 generations back to K000943 (2001). 5 ancestors in all.
9 later devices descend from it; 6 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143100: NP Cement HV Genta;NP Cement LV Genta;NP Cement HV System Genta;NP Cement LV System Genta, Cossington, Ltd. (2015) Summary page 5.
- (no number) DePuy Prostalac Hip Temporary Prosthesis System: named in the summary without a submission number

## 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
- K231556: SPECTRUM® GV Bone Cement (2023), 1 descendant of its own
- K262290: REMEDY POLY+PLUS SNAP FIT Acetabular Cup (2026), 0 descendants of its own

## Indications for use
The REMEDY PLUS Hip Spacer, which consists of a modular head and stem, 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 and vancomycin are the most appropriate antibiotics based on the susceptibility pattern of the infecting micro-organism(s). The head and stem components are inserted into the acetabular cavity and femoral medullary canal, respectively, following removal of the existing acetabular and femoral components and radical debridement. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection). The REMEDY PLUS Hip Spacer 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, fusion, etc.). The UNITE PLUS Bone Cement is intended for the fixation of a REMEDY PLUS spacer devices to the host bone.

Source page: https://510kreport.com/device/K172906
Methodology: https://510kreport.com/methodology