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A. General indications: These INION OTPS™ BIODEGRADABLE FIXATION SYSTEM issuplants are generally intended for maintenance of reduction of cancellous bone fractures, osteotomies or arthrodeses of the upper extremity, ankle and foot in the presence of appropriate brace and/or immobilization.

B. Specific indications:

• Fractures and osteotomies of the malleoli
• Ankle fractures

The modified Inion OTPS™ Biodegradable Fixation system implants are identical to the currently cleared devices except for the modifications which have been detailed in section 3 of this submission.

Inion OTPS™ Biodegradable Fixation System implants are made of resorbable polylactic acid / trimethylenecarbonate copolymers. Inion O'EPS™ Biodegradable Fixation System implants gradually lose their strength during 18-36 weeks in vivo with complete strength loss and resorption within two to four years.

This document is a 510(k) summary for a modification to an existing biodegradable fixation system. It confirms the device's substantial equivalence to a predicate device and does not involve AI or a clinical study to establish acceptance criteria or device performance in the way described in your request. Therefore, I cannot provide the detailed information about acceptance criteria, study design, and AI performance from this document.

The document indicates:

• The device is a modified Inion OTPS™ Biodegradable Fixation System.
• The modification makes the implants identical to currently cleared devices except for the modifications detailed in section 3 (which is not provided in the extracted text).
• The manufacturer is asserting substantial equivalence to their predicate device (K030900) based on performance data and specifications.
• No applicable mandatory performance standards exist, but compliance to voluntary consensus standards is listed in the application (details not provided).
• The FDA has reviewed the submission and found the device substantially equivalent.

No information regarding AI, acceptance criteria, or clinical study data is present in these sections of the 510(k) summary.

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