# K122738: Gaitway Implant System, Surgical Instrument Set

- Pathway: 510(k) (Traditional)
- Applicant: Solana Surgical, LLC
- Decided: Nov 7, 2012 after 62 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K792670 (1980). 12 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093820: Subfix Arthroereisis Implant, Models SUT0065, SUT0080, SUT0090, SUT0100, SUT0115, Memometal Technologies (2010) Summary page 1.
- K080280: Sub-Talar Lok, Model 7-11 MM, Instratek, Inc. (2008) Summary page 1.
- K071456: Arthrex Prostop Plus Arthroereisis Subtalar Implant, Arthrex, Inc. (2008) Summary page 1.

## Most influential descendants
- K170688: PIT’Stop® implant (2017), 1 descendant of its own
- K222820: BRM TOOL Screws, BIOPLAN Subtalar Implant (2022), 0 descendants of its own

## Indications for use
The Solana Surgical LLC, Gaitway Implant System is intended to treat the hyperpronated foot and stabilize the subtalar joint. It is intended to block forward, downward and medial displacement of the talus, thus blocking excessive pronation and the resulting sequela.

Source page: https://510kreport.com/device/K122738
Methodology: https://510kreport.com/methodology