Modification to Inion OTPS Biodegradable Fixation System
FDA 510(k)Class II (US FDA 510(k))
by Inion , Ltd.
Identifiers
- 510(k) Number
- K062617 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 device is a modification to the Inion OTPS Biodegradable Fixation System, which consists of resorbable bone screws made of polylactic acid/trimethylenecarbonate copolymers. It is used for internal fixation of cancellous bone fractures, osteotomies, or arthrodeses in the upper extremity, ankle, and foot, providing temporary mechanical stability for bone healing as strength gradually decreases over 18-36 months.
The device is supplied as a sterile, single-use implant intended for use in surgical settings. It received FDA 510(k) clearance (K062617) on October 4, 2006, and is classified under product code HWC with an orthopedic advisory committee review. The modification specifically relates to the Inion OTPS Biodegradable Pin, indicated for maintenance of alignment and fixation of bone fractures, osteotomies, arthrodeses, or bone grafts when used with appropriate additional immobilization such as rigid fixation implants, cast, or brace.
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: Modification to Inion Otps Biodegradable Fixation System, Modification To: Inion Otps Biodegradable Pin, PDF K062617 Modification to Inion Otps Biodegradable Fixation System, MODIFICATION TO: INION OTPS BIODEGRADABLE PIN 510(k)… - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K062617 | Class II | Active |
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Manufacturer
- Manufacturer
- Inion , Ltd.
Sources (1)
- FDA 510(k) K062617 24 fields · synced Sep 24, 2026