# K051836: Skelite Resorbable Cement Restrictor

- Pathway: 510(k) (Traditional)
- Applicant: Millenium Biologix, Inc.
- Decided: Nov 21, 2005 after 138 days
- Product code: JDK (Prosthesis, Hip, Cement Restrictor)
- Device class: 2
- Regulation: 21 CFR 878.3300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The SkeliteT M Resorbable Cement Restrictor is intended to be used in orthopaedic surgeries, such as those involving the femoral and tibia canals in hip stem and total knee replacement. This device is not appropriate for acetabular cup surgeries, nor is it intended for any spinal indications.

Source page: https://510kreport.com/device/K051836
Methodology: https://510kreport.com/methodology