# K252326: InterSpace GV Hip Spacer

- Pathway: 510(k) (Special)
- Applicant: Tecres S.P.A.
- Decided: Aug 6, 2025 after 12 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 K000943 (2001). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031841: Spacer G Temporary Hip Prosthesis, Exactech, Inc. (2004) Summary page 5.
- K172906: REMEDY PLUS Hip Spacer, UNITE PLUS Bone Cement, Osteoremedies, LLC (2018) Summary page 5.

## Indications for use
The InterSpace GV Hip Spacer is indicated for temporary use (maximum 180 days) as a 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 device is inserted into the femoral medullary canal and acetabular cavity following removal of the existing femoral and acetabular implants and debridement. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection). The InterSpace GV 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.).

Source page: https://510kreport.com/device/K252326
Methodology: https://510kreport.com/methodology