In2Bones PIT’Stop® Implant
- CataBlog
- Jan 1, 2018
- 2 min read
Vendor/Manufacturer: In2Bones SAS
Product/Product Line: PIT’Stop® implant
FDA Regulation Medical Specialty: Orthopedic Devices - Prosthetic Devices
FDA Regulation Number: 888.3040
FDA Regulation Description Classification Name:
Smooth or threaded metallic bone fixation fastener
FDA Classification Product Code: HWC
FDA Classification Product Code Device Name:
Screw, Fixation, Bone
SUBSTANTIALLY EQUIVALENT to the following products:
Device Description:
The PIT’Stop® implant is a cannulated implant composed of two symmetrical and flattened sides, and small blades.
The PIT’Stop® implant is designed to adequately maintain the filling of the sinus tarsi, and is made of PEEK, a material recognized for its mechanical and radiolucent properties. The PIT’Stop® implant is introduced into the axis of sinus tarsi, and its fixation is performed by anti-return flanges.
The PIT’Stop implant should be removed:
at the end of the growth when used in pediatric patients or
by 12 months when used in adult patients or
if pain occurs earlier
Sizes: The PIT’Stop® implant is designed in 7 sizes, from 10mm to 17mm.
Material: The PIT’Stop® implant is made of PEEK according to standard ASTM F2026 and include markers made of tantalum according to ASTM F560.
Single use: The PIT’Stop® implant is designed for single use only.
Sterilization: The PIT’Stop® implant is supplied sterile, using gamma irradiation.
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
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