# K974289: Epi-Union Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica, Inc.
- Decided: Feb 12, 1998 after 90 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
25 later devices descend from it; 2 cite it directly.
0 of 26 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) Synthes’ ASIF® Implants: named in the summary without a submission number
- (no number) Dupont Distal Humeral Plate System: named in the summary without a submission number
- (no number) BG Compression System: named in the summary without a submission number

## Most influential descendants
- K982545: BMP Cable System (1998), 17 descendants of its own
- K031162: Smith & Nephew Orthopaedic Cabling System (2003), 10 descendants of its own
- K152289: Alians Elbow Locking Plating System (2016), 6 descendants of its own
- K203405: EVOS Large Fragment Plating System (2021), 3 descendants of its own
- K173641: Activ Ankle (2018), 3 descendants of its own

## Indications for use
The EPI-Union Plating System is intended for use in the internal fixation of long bone fractures and long bone reconstruction.

Source page: https://510kreport.com/device/K974289
Methodology: https://510kreport.com/methodology