# K031961: Inion Otps Biodegradable Mesh Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Inion, Ltd.
- Decided: Mar 1, 2004 after 250 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K974017 (1998). 4 ancestors in all.
21 later devices descend from it; 2 cite it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021164: Macropore OS Trauma, Macropore Biosurgery, Inc. (2002) Summary page 1.
- K994158: Macrosorbos Protective Sheet, Macropore Biosurgery, Inc. (2000) Summary page 1.
- K003788: Synthes Resorable Meshes and Sheets, Synthes (Usa) (2001) Summary page 1.

## Most influential descendants
- K123672: Inion Freedomscrew (Alternative Marketing Name: Inion Otps Freedomscrew) (2013), 17 descendants of its own
- K160304: OsteoBullet Compression Screw (2016), 8 descendants of its own
- K193660: OSSIOfiber™ Compression Screws (2020), 6 descendants of its own
- K221193: OSSIOfiber Compression Screw, OSSIOfiber Compression Screw, 6.5mm (2022), 4 descendants of its own
- K213596: OSSIOfiber Compression Screw, 3.5mm (2021), 4 descendants of its own

## Indications for use
Inion OTP)IM Biodegradable Mesh Plating System is intended to sustain the relative position of weak bony tissue, e.g. bone grafts, bone graft substitutes, or bone fragments from comminuted fractures. The Inion OTPSIM Biodegradable Mesh Plating System is also indicated for cement restriction in total joint arthroplasty procedures. Only when used in conjunction with traditional rigid fixation, the Inion OTPSIM Biodegradable Mesh Plating System is intended to sustain the relative position of weak bony tissue in trauma and reconstructive orthopaedic procedures involving the following: • Long bones • Flat bones • Short bones • Irregular bones • Appendicular skeleton • Thorax When used alone (without traditional rigid fixation), the Inion OTPSI Biodegradable Mesh Plating System is intended to maintain the relative position of bone grafts or bone graft substitutes in reconstructive orthopaedic procedures involving: • Tumor resections where bone strength has not been compromised. • Iliac crest harvest sites.

Source page: https://510kreport.com/device/K031961
Methodology: https://510kreport.com/methodology