# K133449: Kasm Knee Articulating Spacer Molds

- Pathway: 510(k) (Traditional)
- Applicant: Ortho Development Corp.
- Decided: Feb 18, 2014 after 98 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: 3 generations back to K936159 (1995). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050210: Disposable Cement Spacer Molds for Temporary Knee Prostheses, Biomet, Inc. (2005) Summary page 1.

## Indications for use
KASM® is intended for use in temporary total knee arthroplasty procedures with the following indications: 1. Active sepsis which requires a two-stage revision arthroplasty procedure 2. Skeletally mature patients who will consistently use limited mobility assistive devices such as a walker, canes, crutches, etc., for the entire implantation period 3. Implantation period of 180 days or less Use only with polymethylmethacrylate/gentamicin bone cement. The articulating cement spacer prosthesis fashioned using the KASM® mold is intended for cemented fixation only.

Source page: https://510kreport.com/device/K133449
Methodology: https://510kreport.com/methodology