# K040389: Coonrad/Morrey Elbow Cement Restrictor

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer, Inc.
- Decided: May 17, 2004 after 90 days
- Product code: JDC (Prosthesis, Elbow, Constrained, Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3150
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K950312 (1995). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001733: Allen Medullary Cement Plugs, Zimmer Poly Plug Intramedullary System, Model 8011 Series & 1109 & 8109 Series, Zimmer, Inc. (2000)
- K950312: Alpha System, Zimmer, Inc. (1995) Summary page 1.

## Most influential descendants
- K181307: Zimmer Nexel Total Elbow, Connrad/Morrey Total Elbow (2019), 0 descendants of its own

## Recalls of this device
- Jun 8, 2009 · Not classified · Z-1700-2009: The seal on the sterile barrier pouch may be inadequate, resulting in lack of assurance of sterility.

## Indications for use
Intramedullary cement plugs are indicated for use in total joint arthroplasty to control, restrict or impede the flow of cement. The larger intramedullary cement plugs are useful in revision surgery where a wide, smooth intramedullary canal must be plugged.

Source page: https://510kreport.com/device/K040389
Methodology: https://510kreport.com/methodology