# K001733: Allen Medullary Cement Plugs, Zimmer Poly Plug Intramedullary System, Model 8011 Series & 1109 & 8109 Series

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer, Inc.
- Decided: Jun 20, 2000 after 13 days
- Product code: JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3350
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
27 later devices descend from it; 5 cite it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K111546: U2 Hip System (2011), 13 descendants of its own
- K152084: Bencox M Stem (Bencox Hip System) and Bencox ID Cemented Stem (with Centralizer) & Bencox Bone Plug (2016), 7 descendants of its own
- K122185: U-Motion II Acetabular System (2013), 7 descendants of its own
- K162127: Bencox M Stem Lateralized & Bencox Mirabo Cup System (2016), 6 descendants of its own
- K172806: Bencox Mirabo Cup System (2017), 4 descendants of its own

## Recalls of this device
- Jun 8, 2009 · Not classified · Z-1699-2009: The seal on the sterile barrier pouch may be inadequate, resulting in lack of assurance of sterility.

Source page: https://510kreport.com/device/K001733
Methodology: https://510kreport.com/methodology