# K980843: Exeter Intramedullary Bone Plug

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica, Inc.
- Decided: Jun 2, 1998 after 90 days
- Product code: JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3350
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K891454 (1989). 4 ancestors in all.
44 later devices descend from it; 5 cite it directly.
0 of 49 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K933077: Exeter Intramedullary Bone Plug, Howmedica Corp. (1995) Summary page 1.
- K974054: Distal Centralizer, Exeter II Hip System, Howmedica, Inc. (1997) Summary page 1.

## Most influential descendants
- K982918: Depuy C-Stem System (1998), 25 descendants of its own
- K042959: Depuy C-Stem Amt Hip Prosthesis (2004), 23 descendants of its own
- K082239: Depuy C-Stem Amt (2008), 14 descendants of its own
- K013350: Modification to Depuy C-Stem System (2001), 14 descendants of its own
- K220216: C-Stem AMT LE Prosthesis (2022), 8 descendants of its own

## Indications for use
The Exeter II Intramedullary Bone Plug is intended to be used to restrict the migration of bone cement down the femoral canal and permit cement pressurization during total hip arthroplasty. The Exeter Intramedullary Bone Plug is intended to be used with bone cement.

Source page: https://510kreport.com/device/K980843
Methodology: https://510kreport.com/methodology