# K974054: Distal Centralizer, Exeter II Hip System

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica, Inc.
- Decided: Dec 23, 1997 after 57 days
- Product code: JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3350
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K891454 (1989). 2 ancestors in all.
45 later devices descend from it; 8 cite it directly.
0 of 48 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K936127: Howmedica Premium Femoral Component, Howmedica, Inc. (1994) Summary page 1.
- K891454: Exeter II Total Hip System, Howmedica Corp. (1989). Our OCR of the scanned summary read K891445, FDA’s number for Latex Examination Gloves (Superior Healthcare Group, Inc.). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Exeter II Distal Centralizer”.

## Most influential descendants
- K980843: Exeter Intramedullary Bone Plug (1998), 44 descendants of its own
- 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

## Recalls of this device
- Mar 31, 2010 · Not classified · Z-1593-2010: One lot of 13 mm medium distal ring centralizers and 14 mm large distal ring centralizer have been labeled incorrectly. The size 14 Large centralizers have been labeled as size 13 Medium centralizers 
- Mar 31, 2010 · Not classified · Z-1594-2010: One lot of 13 mm medium distal ring centralizers and 14 mm large distal ring centralizer have been labeled incorrectly. The size 14 Large centralizers have been labeled as size 13 Medium centralizers 
- Mar 29, 2010 · Not classified · Z-1601-2010: Stryker became aware that device labels have incorrectly printed manufacture dates and thus incorrect expiration dates on the product label.

## Indications for use
The Exeter Il Distal Centralizer is intended to be used to centralize the femoral stem within the intramedullary canal. The Distal Centralizer is intended to be used with bone cement.

Source page: https://510kreport.com/device/K974054
Methodology: https://510kreport.com/methodology