# K022729: Vented Cement Restrictor

- Pathway: 510(k) (Traditional)
- Applicant: Amedica Corp.
- Decided: Nov 14, 2002 after 90 days
- Product code: JDX (Instrument, Surgical, Sonic And Accessory/Attachment)
- Device class: 2
- Regulation: 21 CFR 888.4580
- 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 K003718 (2001). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013663: Cement Restrictor, Medtronic Sofamor Danek, Inc. (2001)
- K900462: Osteonics Cement Restrictor, Osteonics Corp. (1990) Summary page 1.
- K830949: Polyethylene Medullary Plug - Stiihmer/, Allo Pro Corp. (1983) Summary page 1.

## Cited in the summary but kept off the family tree
- K511060: Polyethylene Medullary Plug. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree
- K072205: Visage Pacs/CS, Release Version 5.0, Mercury Computer Systems, Inc. (2007). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K050699: Modification to: Vented Cement Restrictor, Model 60102-000-001/004 (2005), 0 descendants of its own

## 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/K022729
Methodology: https://510kreport.com/methodology