# K131061: Restore Bunion Correction System

- Pathway: 510(k) (Traditional)
- Applicant: Nextremity Solutions
- Decided: Aug 28, 2013 after 134 days
- Product code: JDR (Staple, 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
Longest line of descent: 7 generations back to K000684 (2000). 57 ancestors in all.
15 later devices descend from it; 4 cite it directly.
0 of 73 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121277: Z-Snap Off Screw, Z-Double Thread Compression Screw, Z-Guide Wire, Z-Staple, Z-Medical GmbH & Co. KG (2012) Summary page 1.
- K103705: Low Profile Screws, Arthrex, Inc. (2011) Summary page 1.
- K092670: Biodrive Micro Screw System, Ebi,Llc D/B/A Biomet Trauma (2009) Summary page 1.

## Most influential descendants
- K170214: Additive Orthopaedics Locking Lattice Plate (2017), 8 descendants of its own
- K183011: Additive Orthopaedics Patient Specific 3D Locking Lattice Plates (2019), 5 descendants of its own
- K193614: FINE Osteotomy around the knee (2020), 4 descendants of its own
- K242415: TMC Compression Implant System (2024), 3 descendants of its own
- K211646: FINE Osteotomy (2021), 3 descendants of its own

## Indications for use
The RestoreTM Fixation System is indicated for alignment, stabilization and fusion of fractures, osteotomies and arthrodesis of small bones such as the foot and ankle.

Source page: https://510kreport.com/device/K131061
Methodology: https://510kreport.com/methodology