# K081244: Lower Extremity External Fixation - Expanded Indications

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Trauma
- Decided: Jul 30, 2008 after 90 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
Longest line of descent: 5 generations back to K993886 (1999). 34 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040935: Ebi Xfix DFS System, Ebi, L.P. (2004) Summary page 1.
- K031919: Ebi Xfix DFS System, Ebi, L.P. (2003) Summary page 1.
- K024129: Modification to Ebi Xfix DFS System, Ebi, L.P. (2003) Summary page 1.
- K023399: Ebi Xfix DFS System, Ebi, L.P. (2002) Summary page 1.
- K023324: Modification to Ebi Xfix DFS System, Ebi, L.P. (2002) Summary page 1.
- K022319: Ebi Xfix DFS System, Ebi, L.P. (2002) Summary page 1.
- K021091: Ebi Xfix DFS System, Ebi, L.P. (2002) Summary page 1.
- K014276: Modification to Ebi Xfix DFS System, Ebi, L.P. (2002) Summary page 1.
- K013540: Ebi Xfix Access Pelvic Fixator, Ebi, L.P. (2001) Summary page 1.
- K013378: Ebi Xfix DFS System, Ebi, L.P. (2001) Summary page 1.
- K012024: Ebi Xfix DFS System, Ebi, L.P. (2001) Summary page 1.
- K011697: Ebi Xfix Access Pelvic Fixator, Ebi, L.P. (2001) Summary page 1.
- K000319: Ebi Xfix DFS System, Ebi, L.P. (2000) Summary page 1.
- K970290: Ebi X Fix Dynafix Mini External Fixation System, Ebi, L.P. (1997) Summary page 1.
- K961433: Ebi X Fix Dynafix System/Ebi DFS Distal Radius Fixator SC Bone Screws, Electro-Biology, Inc. (1996) Summary page 1.
- K953406: Ebi X Fix Dynafix System (DFS), Electro-Biology, Inc. (1995) Summary page 1.
- K951357: Ebi Small External Fixator (S/E/F/), Electro-Biology, Inc. (1995) Summary page 1.
- K021031: Ebi Xfix Rail System, Ebi, L.P. (2002) Summary page 1.
- K010437: Modification to Ebi Xfix DFS Rail System, Ebi, L.P. (2001) Summary page 1.
- K000083: Ebi Xfix DFS Rail System, Ebi, L.P. (2000) Summary page 1.
- K991941: Ebi Xfix DFS Rail System, Electro-Biology, Inc. (1999) Summary page 1.
- K040833: Modification to Ebi Xfix Vision Fixation System, Ebi, L.P. (2004) Summary page 1.
- K033635: Modification to Ebi Xfix Vision Fixation System, Ebi, L.P. (2003) Summary page 1.
- K020141: Modification to Ebi Xfix Vision Fixation System, Ebi, L.P. (2002) Summary page 1.
- K014194: Modification to Ebi Xfix Vision Fixation System, Ebi, L.P. (2002) Summary page 1.
- K011711: Modification to Ebi Efix Vision Fixation System, Ebi, L.P. (2001) Summary page 1.
- K993886: Ebi Xfix Vision Fixation System, Ebi, L.P. (1999) Summary page 1.
- K031093: Ebi Xfix Optirom Knee Fixator, Ebi, L.P. (2003) Summary page 1.
- K030372: Modification to Ebi Dynafix Diaphyseal Correction System, Ebi, L.P. (2003) Summary page 1.
- K024248: Modification to Ebi Xfix DFS System Metaphyseal Correction System, Ebi, L.P. (2003) Summary page 1.
- K021695: Ebi Dynafix Diaphyseal Correction System, Ebi, L.P. (2002) Summary page 1.
- K001358: Ebi Xfix DFS Metaphyseal Correction System, Ebi, L.P. (2000) Summary page 1.
- K052037: Modification to Hoffmann II Micro External Fixation System, Howmedica Osteonics Corp. (2005) Summary page 1.
- K050048: Hoffman II Micro External Fixation System, Howmedica Osteonics Corp. (2005) Summary page 1.

## Most influential descendants
- K122210: Newfix External Fixation System (2013), 0 descendants of its own
- K102843: Mac Male Adapter (2011), 0 descendants of its own

## Recalls of this device
- Aug 21, 2019 · Class II · Z-0528-2020: Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.

## Indications for use
Unilateral external fixation device intended for use in children and adults in the treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation, and other bone conditions amendable to treatment by use of the external fixation modality. For the XFIX® DFS® Rail System the indications are unilateral external fixation device intended for use in children and adults in the treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation, acute or gradual correction and other bone conditions amendable to treatment by use of the external fixation modality.

Source page: https://510kreport.com/device/K081244
Methodology: https://510kreport.com/methodology