# K000083: Ebi Xfix DFS Rail System

- Pathway: 510(k) (Special)
- Applicant: Ebi, L.P.
- Decided: Feb 3, 2000 after 22 days
- Product code: KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component)
- Device class: 2
- Regulation: 21 CFR 888.3030
- 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.
9 later devices descend from it; 4 cite it directly.
0 of 10 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
- K021031: Ebi Xfix Rail System (2002), 8 descendants of its own
- K031875: Inter-OS Limb Lengthener (2003), 4 descendants of its own
- K192181: PRECICE Plating System (2019), 2 descendants of its own
- K081244: Lower Extremity External Fixation - Expanded Indications (2008), 2 descendants of its own
- K202348: External Remote Controller ERC 4P (2020), 0 descendants of its own

## Recalls of this device
- Nov 9, 2012 · Class II · Z-0527-2013: It was reported that the number scale/graduation markings were missing on 14 pieces of the swivel clamp.

Source page: https://510kreport.com/device/K000083
Methodology: https://510kreport.com/methodology