# K181732: InterSpace Knee Extra-Large Size, InterSpace Knee ATS

- Pathway: 510(k) (Traditional)
- Applicant: Tecres S.P.A.
- Decided: Apr 27, 2019 after 299 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: 6 generations back to K936159 (1995). 14 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062274: Spacer-K Temporary Knee Spacer with Gentamicin, Models SPK0021, SPK0121, SPK0221, SPK0321, Tecres S.P.A. (2008) Summary page 5.
- K101356: Spacer-G and Spacer-K, Tecres S.P.A. (2011) Summary page 5.
- K112470: 2GC Hip/Knee Modular Spacer, Mandell Horwitz Consultants, LLC (2012) Summary page 8.

## Most influential descendants
- K240856: Hip Spacer Molds; Knee Spacer Molds; Shoulder Spacer Molds (2024), 0 descendants of its own

## Indications for use
InterSpace Knee is indicated for temporary use (maximum 180 days) as a total knee replacement (TKR) in skeletally mature patients undergoing a two-stage procedure due to a septic process. InterSpace Knee is applied on the femoral condyles and on the tibial plate 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). InterSpace Knee 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 material (gentamicin/polymethylmethacrylate), the Interspace Knee is only indicated for patients who will consistently use traditional mobility assist devices (e.g. crutches, walkers, canes) throughout the implantation period InterSpace Knee ATS is indicated for temporary use (maximum 180 days) as an adjunct to total knee replacement (TKR) in skeletally mature patients undergoing a two-stage procedure due to a septic process, and where a large tibial defect is present. InterSpace Knee ATS is applied on the tibial plate following removal of the existing implant and radical debridement. The device must be combined with the tibial component of InterSpace Knee. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection). InterSpace Knee ATS 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 material (gentamicin/polymethylmethacrylate), the Interspace Knee ATS 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/K181732
Methodology: https://510kreport.com/methodology