In2Bones Fracture and Correction System
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K170518 FDA 510(k)
- FDA Product Code
- HRS FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3030 FDA 510(k)
- Regulation Number
- 888.3030 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The In2Bones Fracture and Correction System is a medical device classified under orthopedic hardware, designed for internal fixation of bone fractures, fusions, osteotomies, and non-unions. It includes plates and screws engineered to stabilize and correct skeletal alignment in targeted anatomical sites, ensuring proper healing and structural integrity.
This system is supplied sterile and intended for single-use, adhering to FDA 510(k) clearance (K170518) and MDR compliance. It is intended for use in orthopedic surgical settings, with components available in sizes tailored for specific anatomical applications. Storage and handling follow standard sterile orthopedic device protocols, and regulatory authorizations confirm its safety and performance for intended clinical use.
Frequently asked questions
What types of bone procedures is the In2Bones Fracture and Correction System designed to assist with?
The In2Bones Fracture and Correction System is specifically engineered for internal fixation in orthopedic surgeries, including the stabilization of bone fractures, spinal fusions, osteotomies (controlled bone cuts), and non-unions (failed healing sites). Its plates and screws are tailored to restore alignment and promote proper skeletal healing in targeted anatomical areas.
Is the In2Bones system intended for reuse, or is it meant to be used only once per patient?
The In2Bones Fracture and Correction System is explicitly designed for single-use only, adhering to standard sterile medical device protocols. This ensures patient safety and maintains the integrity of the sterile field during orthopedic procedures.
How should the In2Bones system be stored to preserve its sterility?
Since the system is supplied sterile, it must be stored according to standard sterile orthopedic device protocols—typically in sealed, moisture-resistant packaging until immediate preoperative use. Avoid exposure to moisture, contamination, or extreme temperatures, as this could compromise sterility.
What regulatory pathways does the In2Bones system follow, and how does this affect its use?
The In2Bones Fracture and Correction System has received FDA 510(k) clearance (K170518) under the Traditional review pathway, with a decision classified as *Substantially Equivalent* to predicate devices. It also complies with the EU Medical Device Regulation (MDR). These authorizations confirm its safety and performance for orthopedic internal fixation in clinical settings, ensuring it meets regulatory standards for use.
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. Sources consulted: In2Bones Fracture and Correction System (K170518) — FDA 510 (k ..., In2bones-Usa FDA Filings - FDA.report, FDA Clears In2Bones USA's Foot Fracture and Correction System
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K170518 | Class II | Active |
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Manufacturer
- Manufacturer
- In2Bones USA, LLC
Sources (2)
- FDA 510(k) K170518 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 18, 2026