# K112470: 2GC Hip/Knee Modular Spacer

- Pathway: 510(k) (Traditional)
- Applicant: Mandell Horwitz Consultants, LLC
- Decided: Apr 5, 2012 after 223 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 K936159 (1995). 13 ancestors in all.
16 later devices descend from it; 8 cite it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101356: Spacer-G and Spacer-K, Tecres S.P.A. (2011). Cleared while this submission was under review Summary page 2.

## Most influential descendants
- K183017: Remedy Femoral Component 84mm, Remedy Stemmed Knee Spacer (2019), 5 descendants of its own
- K173967: Remedy Acetabular Cup (2018), 5 descendants of its own
- K191981: REMEDY Acetabular Cup (2019), 4 descendants of its own
- K240683: Rx Knee System (2024), 2 descendants of its own
- K192995: OsteoRemedies Hip Spacer System (2020), 2 descendants of its own

## Indications for use
The Hip Modular 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 gentamnicin is the most appropriate antibiotic based on the susceptibility pattern of the infecting micro-organisms. 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 Hip Modular 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 Knee Modular Spacer, which consists of a modular femoral, tibial and tibial insert component, is indicated for temporary use (maximum 180 days) as an adjunct to total knee replacement (TKR) in 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 device is applied on the femoral condyles (femoral component) and on the tibial plate (tibial component) following removal of the existing implant and radical debridement. The use of the tibial insert component is optional, when a large tibial defect is present. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection). The Knee Modular 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 (gentamicin/polymethylmethacrylate), 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/K112470
Methodology: https://510kreport.com/methodology