# K260063: GSPE Spacer

- Pathway: 510(k) (Traditional)
- Applicant: The General Hospital Corporation, d/b/a Massachusetts
- Decided: Sep 11, 2026 after 246 days
- Product code: JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3560
- 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). 48 ancestors in all.
No later device cites it as a predicate yet.
0 of 49 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.
- K240683: Rx Knee System, Signature Orthopaedics Pty, Ltd. (2024) Summary page 5.

## Indications for use
The GSPE Spacer includes femoral and tibial components, and is indicated for temporary use (maximum 180 days) as an adjunct to total knee replacement (TKR) in skeletally mature patients undergoing a two-stage revision procedure due to a septic process and where gentamicin is the most appropriate antibiotic based on the susceptibility pattern of the infecting microorganism(s). The device is applied on the femoral condyles and on the tibial plateau following removal of the existing implant and radical debridement. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection). The GSPE 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.) Because of the inherent mechanical limitations of the device materials, the device is only indicated for patients who will consistently use traditional mobility assist devices (e.g., crutches, walkers, canes) throughout the implantation period.

Source page: https://510kreport.com/device/K260063
Methodology: https://510kreport.com/methodology