Inion Ltd.
FDA Regulatory Profile
Inion Ltd. appears in FDA public data with 1 recall, 37 510(k) clearances, 4 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1478-2017, Class II) was initiated on March 1, 2017. Its most recent 510(k) clearance was granted on November 7, 2025.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 37
- Inspections
- 4
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1478-2017 | Class II | Inion GRT Tack, drill bit and tack appl., 4x, Sterile. Is indicated for the surgical treatment o | March 1, 2017 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K251441 | Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation Syste | November 7, 2025 |
| K251472 | Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System; Inion CPS 1.5 Baby Bioabsorbable Fixation Syste | July 11, 2025 |
| K203105 | Inion CompressOn Screw | January 13, 2021 |
| K191764 | Inion BioRestore | July 31, 2019 |
| K151360 | Inion Spinal Graft Containment System | October 6, 2015 |
| K133932 | INION FREEDOMPIN | April 11, 2014 |
| K123672 | INION FREEDOMSCREW (ALTERNATIVE MARKETING NAME: INION OTPS FREEDOMSCREW) | February 27, 2013 |
| K122890 | INION CPS ORBITAL PLATES | January 29, 2013 |
| K090177 | INION BIORESTORE BIODEGRADABLE BONE GRAFT SUBSTITUTE | February 20, 2009 |
| K071810 | INION SPINAL GRAFT CONTAINMENT SYSTEM | July 11, 2008 |
| K070998 | INION BIORESTORE | October 11, 2007 |
| K071464 | INION HEXALON BIODEGRADABLE ACL/PCL SCREW | August 3, 2007 |
| K070784 | INION BIORESTORE | July 24, 2007 |
| K063410 | INION CPS/OTPS FREEDOMPLATE | January 23, 2007 |
| K062782 | INION ANCHRON PLUS BIODEGRADABLE ANCHOR SYSTEM, MODEL ANC-6001 | November 9, 2006 |
| K062617 | MODIFICATION TO INION OTPS BIODEGRADABLE FIXATION SYSTEM | October 4, 2006 |
| K060393 | INION HEXALON BIODEGRADABLE ACL/PCL SCREW | March 13, 2006 |
| K051821 | INION S-1 BIODEGRADABLE ANTERIOR CERVICAL FUSION SYSTEM | November 25, 2005 |
| K052624 | INION OTPS BIODEGRADABLE DISTAL RADIUS PLATE | November 16, 2005 |
| K052444 | INION CPS BABY 1.5 BIOABSORBABLE FIXATION SYSTEM | September 20, 2005 |