# K963309: Apex Hole Eliminator PS

- Pathway: 510(k) (Traditional)
- Applicant: Depuy, Inc.
- Decided: Nov 12, 1996 after 82 days
- Product code: LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3358
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
6 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) DePuy Duraloc® 100C Acetabular Cup: named in the summary without a submission number
- (no number) Wright Medical Interseal™ Acetabular Components: named in the summary without a submission number

## Most influential descendants
- K231873: DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip Prosthesis – MR Conditional, DePuy SUMMIT Cemented Hip Prosthesis – MR Conditional, DePuy SUMMIT FX Cemented Hip Prosthesis – MR Conditional, DePuy SUMMIT Basic Press-Fit Hip Prosthesis – MR Conditional (2024), 5 descendants of its own
- K251292: RECLAIM Monobloc Revision Femoral Stem (2025), 1 descendant of its own
- K243977: EMPHASYS Acetabular System (2025), 1 descendant of its own
- K260173: M-Vizion Femoral Revision System Extension (2026), 0 descendants of its own
- K252067: Velora Acetabular System (2025), 0 descendants of its own

## Indications for use
The Apex Hole Eliminator PS is a threaded plug intended to close the apical hole of the Duraloc® series two-piece acetabular cups. It is intended for use in Duraloc cups implanted with or without bone cement. It can be used after insertion of the acetabular cup in a cementless technique once the cup is well seated to prevent movement of blood or particles from behind the shell through the hole or it can be placed prior to insertion of the cup if the cup is being cemented into place to prevent cement from coming through the apical hole. The Apex Hole Eliminator PS also provides support of the polyethylene liner utilized in the metal shell, assuring full, congruent, uninterrupted support of the liner within the shell, and eliminating the potential of cold flow of the liner into the apical hole of the metal shell.

Source page: https://510kreport.com/device/K963309
Methodology: https://510kreport.com/methodology