# K050699: Modification to: Vented Cement Restrictor, Model 60102-000-001/004

- Pathway: 510(k) (Special)
- Applicant: Amedica Corp.
- Decided: Apr 15, 2005 after 28 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
Longest line of descent: 4 generations back to K003718 (2001). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022729: Vented Cement Restrictor, Amedica Corp. (2002) Summary page 1.
- K040276: Quantum Cement Restrictor, Quantum Orthopedics (2004) Summary page 1.

## Indications for use
The Vented Cement Restrictor is intended for use as a cement restrictor used in the treatment of the following: * Total Hip Arthroplasty * Total Knee Arthroplasty * Total or Hemi Shoulder Arthroplasty The device is not intended for use in spinal surgeries.

Source page: https://510kreport.com/device/K050699
Methodology: https://510kreport.com/methodology