PIT’Stop® implant
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
by In2Bones SAS
Identifiers
- 510(k) Number
- K170688 FDA 510(k)
- FDA Product Code
- HWC FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3040 FDA 510(k)
- Regulation Number
- 888.3040 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The PITStop Implant is a surgical device classified under the orthopedic category, designed to address peri-implant tibial tunnel enlargement (PITTE) in anterior cruciate ligament (ACL) reconstruction procedures. Constructed as a rigid fixation device, it stabilizes the tibial tunnel during bone healing to prevent widening and ensure proper integration of the graft.
This implant is supplied sterile and intended for single-use in orthopedic settings. It is manufactured under FDA 510(k) clearance (K170688) and complies with the Medical Device Directive (MDD) and Medical Device Regulation (MDR). The device is available in a standardized form without additional sizing specifications, and its use requires adherence to sterile surgical protocols. No MRI safety information is provided in the specifications.
Frequently asked questions
What clinical issue does the PITStop Implant specifically address in ACL reconstruction surgeries, and how does it work?
The PITStop Implant is designed to address peri-implant tibial tunnel enlargement (PITTE), a complication that can occur during anterior cruciate ligament (ACL) reconstruction. It functions as a rigid fixation device that stabilizes the tibial tunnel during the bone healing process, preventing tunnel widening and promoting proper graft integration. By maintaining tunnel stability, it helps preserve the structural integrity of the reconstructed ACL.
Is the PITStop Implant reusable, or is it intended for single-use only? How should it be handled in the operating room?
The PITStop Implant is intended for single-use only and is supplied sterile. This means it must be used once per patient and then discarded. In the operating room, it requires adherence to sterile surgical protocols to ensure patient safety, as with any single-use orthopedic device.
Are there different sizes or models of the PITStop Implant, or is it available in a single standardized form?
The PITStop Implant is supplied in a standardized form without additional sizing specifications, meaning there is no variation in dimensions or configurations. Clinicians do not need to select a specific size; the device is designed to be universally applicable for its intended use in tibial tunnel stabilization.
How is the PITStop Implant regulated, and what regulatory pathways does it follow?
The PITStop Implant is regulated through multiple pathways: it holds FDA 510(k) clearance (K170688), meaning it has been deemed substantially equivalent to a legally marketed device in the U.S. It also complies with the Medical Device Directive (MDD) and the Medical Device Regulation (MDR) in the European Union. The device was reviewed by the FDA’s Orthopedic (OR) Advisory Committee under the Traditional 510(k) pathway and is classified under product code HWC for orthopedic fixation devices.
Can the PITStop Implant be used with MRI imaging, or are there any restrictions regarding its use with magnetic resonance?
The provided specifications for the PITStop Implant do not include any MRI safety information, meaning there is no explicit confirmation of its compatibility with MRI imaging. Clinicians should exercise caution and verify compatibility with their specific MRI system before use, as metallic implants can interfere with imaging or pose safety risks.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K170688 | Class II | Active |
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Manufacturer
- Manufacturer
- In2Bones SAS
Sources (2)
- FDA 510(k) K170688 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026