# K030608: Oti Bone Cement Plug

- Pathway: 510(k) (Traditional)
- Applicant: Osteoimplant Technology, Inc.
- Decided: Jun 12, 2003 after 106 days
- Product code: JDK (Prosthesis, Hip, Cement Restrictor)
- Device class: 2
- Regulation: 21 CFR 878.3300
- Recalls of this device: 6 (0 Class I)
- 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.

## Recalls of this device
- Sep 19, 2007 · Not classified · Z-0311-2008: Device marketed without label warning required in the device's 510(k) approval letter. (In part-Warning: This device is not intended for any spinal indications.....)
- Sep 19, 2007 · Not classified · Z-0307-2008: Device marketed without label warning required in the device's 510(k) approval letter. (In part-Warning: This device is not intended for any spinal indications.....)
- Sep 19, 2007 · Not classified · Z-0308-2008: Device marketed without label warning required in the device's 510(k) approval letter. (In part-Warning: This device is not intended for any spinal indications.....)
- Sep 19, 2007 · Not classified · Z-0309-2008: Device marketed without label warning required in the device's 510(k) approval letter. (In part-Warning: This device is not intended for any spinal indications.....)
- Sep 19, 2007 · Not classified · Z-0310-2008: Device marketed without label warning required in the device's 510(k) approval letter. (In part-Warning: This device is not intended for any spinal indications.....)
- Sep 19, 2007 · Not classified · Z-0306-2008: Device marketed without label warning required in the device's 510(k) approval letter. (In part-Warning: This device is not intended for any spinal indications.....)

## Indications for use
The OTI Bone Cement Plug is intended to allow bone cement pressurization in the intramedullary canal and preventing cement seepage distally. The Bone Plug is placed into the intramedullary canal of the femur at a set distance from the proximal end prior to placement of bone cement and Femoral Prosthesis.

Source page: https://510kreport.com/device/K030608
Methodology: https://510kreport.com/methodology