# Inion, Ltd.

- Location (FDA's records): Tampere, FI
- FDA decisions: 37 (2001–2025): 37 510(k) clearances
- Names in FDA's records: Inion , Ltd. (23); Inion OY (14)
- Product codes: HWC (12), JEY (8), OJB (3), MQV (3), HRS (3), HTY (3), MAI (2), LYC (1), NPK (1), HBW (1)
- Predicates its devices cite: 82 (34 its own); citations of its devices by later devices: 65 (34 its own)
- Recalls linked to its devices: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Biomet, Inc.: 8 (https://510kreport.com/company/biomet)
- Macropore Biosurgery, Inc.: 6 (https://510kreport.com/company/macropore-biosurgery)
- Novabone Products, LLC: 5 (https://510kreport.com/company/novabone-products)
- Bionx Implants, Inc.: 4 (https://510kreport.com/company/bionx-implants)
- Arthrex, Inc.: 3 (https://510kreport.com/company/arthrex)
- Biomet Manufacturing Corp: 3 (https://510kreport.com/company/biomet-manufacturing)
- Synthes (Usa): 3 (https://510kreport.com/company/synthes-usa)
- Linvatec Corp.: 2 (https://510kreport.com/company/linvatec)

## Firms that cite its devices most
- Bioretec, Ltd.: 6 (https://510kreport.com/company/bioretec)
- Takiron Co., Ltd.: 3 (https://510kreport.com/company/takiron)
- Synchro Medical: 3 (https://510kreport.com/company/synchro-medical)
- OSSIO, Ltd.: 3 (https://510kreport.com/company/ossio)
- Xtremi-T, LLC: 3 (https://510kreport.com/company/xtremi-t)
- Arthrex, Inc.: 2 (https://510kreport.com/company/arthrex)
- Phalanx Innovations: 1 (https://510kreport.com/company/phalanx-innovations)
- Bio2 Technologies, Inc.: 1 (https://510kreport.com/company/bio2-technologies)

## Its most-cited devices
- K010352: CPS 1.5/2.0/2.5 Bioabsorbable Fixation System (2001), cited by 9
- K030900: Inion Otps Biodegradable Fixaton System (2003), cited by 8
- K031712: Inion Otps Biodegradable Pin (2003), cited by 7
- K123672: Inion Freedomscrew (Alternative Marketing Name: Inion Otps Freedomscrew) (2013), cited by 5
- K010351: Inion CPS Baby 1.5 Bioabsorbable Fixation System (2001), cited by 4
- K033074: Inion GTR Biodegradable Membrane System (2004), cited by 3

## Recent decisions
- K251441: Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System (Nov 7, 2025)
- K251472: Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System; Inion CPS 1.5 Baby Bioabsorbable Fixation System (Jul 11, 2025)
- K203105: Inion CompressOn Screw (Jan 13, 2021)
- K191764: Inion BioRestore (Jul 31, 2019)
- K151360: Inion Spinal Graft Containment System (Oct 6, 2015)
- K133932: Inion Freedompin (Apr 11, 2014)
- K123672: Inion Freedomscrew (Alternative Marketing Name: Inion Otps Freedomscrew) (Feb 27, 2013)
- K122890: Inion CPS Orbital Plates (Jan 29, 2013)

Source page: https://510kreport.com/company/inion