# K093753: Mdpo Frame System

- Pathway: 510(k) (Traditional)
- Applicant: Mdpo, LLC
- Decided: Aug 26, 2010 after 262 days
- Product code: KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component)
- 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
Longest line of descent: 3 generations back to K831576 (1983). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K870961: Richards External Fixation System, Richards Medical Co., Inc. (1987) Summary page 2.
- K962808: Ilizarov External Fixation System, Smith & Nephew Richards, Inc. (1996) Summary page 2.
- K994143: Smith & Nephew External Fixation System [Unilateral (Linear) & Multilateral (Circular) Fixators and Accessories], Smith & Nephew, Inc. (2000) Summary page 2.
- K083789: Ace Fischer External Fixation System, DePuy Orthopaedics, Inc. (2009) Summary page 2.
- K071395: Biomet Vision Footring System, Biomet Manufacturing Corp (2007) Summary page 2.
- K093057: Biomet Vision Footring System, Ebi, L.P. (2009) Summary page 2.

## Indications for use
The MDPO Frame System is indicated for use in the lower extremity for: open and closed long bone fracture fixation, to include tensioned wire fixation of periarticular fractures, arthrodesis, osteotomy, reconstruction, non-unions, pseudoarthrosis, correction of bony or soft tissue defects and deformities, dislocations, arthrodiastasis, and Charcot foot reconstruction and Lisfranc dislocations.

Source page: https://510kreport.com/device/K093753
Methodology: https://510kreport.com/methodology