# K170688: PIT’Stop® implant

- Pathway: 510(k) (Traditional)
- Applicant: In2bones Sas
- Decided: Nov 28, 2017 after 266 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: 6 generations back to K792670 (1980). 26 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061765: Kalix II Implant, New Deal, S.A. (2006) Summary page 5.
- K122738: Gaitway Implant System, Surgical Instrument Set, Solana Surgical, LLC (2012) Summary page 5.
- K153770: OS2(R)-VP Varisation Staple, In2bones Sas (2016) Summary page 5.

## Most influential descendants
- K222820: BRM TOOL Screws, BIOPLAN Subtalar Implant (2022), 0 descendants of its own

## Indications for use
The PIT’Stop implant is indicated for use in the treatment of the hyperpronated foot and stabilization of the subtalar joint. It is designed to block forward, downward and medial displacement of the talus, thus allowing normal subtalar joint motion but blocking excessive pronation and the resulting sequela. - Flat foot treatment in children and adolescents - Congenital flat foot - Non successful long term orthopaedic treatment (shoes, insoles...) - Tarsal coalitions - Painfully flat foot - Supple deformity in posterior tibial tendon dysfunction - Paralytic flat foot - Subtalar instability

Source page: https://510kreport.com/device/K170688
Methodology: https://510kreport.com/methodology