Company ยท FI
Inion , Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 2001 to 2025. Name variants (Inc, Corp, punctuation) are merged.
37510(k) clearances (1 in 12 months)
1recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| HWC | Screw, Fixation, Bone | 12 |
| JEY | Plate, Bone | 8 |
| HRS | Plate, Fixation, Bone | 3 |
| HTY | Pin, Fixation, Smooth | 3 |
| MQV | Filler, Bone Void, Calcium Compound | 3 |
| OJB | Resorbable Spinal Intervertebral Body Fixation Orthosis - Plate | 3 |
| MAI | Fastener, Fixation, Biodegradable, Soft Tissue | 2 |
| NPK | Barrier, Synthetic, Intraoral | 2 |
| HBW | Fastener, Plate, Cranioplasty | 1 |
| LYC | Bone Grafting Material, Synthetic | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 7, 2025 | K251441 | Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System Inion OY, FI | JEY |
| Jul 11, 2025 | K251472 | Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System; Inion CPS 1.5 Baby Bioabsorbable Fixation System Inion OY, FI | HBW |
| Jan 13, 2021 | K203105 | Inion CompressOn Screw Inion OY, FI | HWC |
| Jul 31, 2019 | K191764 | Inion BioRestore Inion OY, FI | MQV |
| Oct 6, 2015 | K151360 | Inion Spinal Graft Containment System Inion OY, FI | OJB |
| Apr 11, 2014 | K133932 | INION FREEDOMPIN Inion OY, FI | HTY |
| Feb 27, 2013 | K123672 | INION FREEDOMSCREW (ALTERNATIVE MARKETING NAME: INION OTPS FREEDOMSCREW) Inion OY, FI | HWC |
| Jan 29, 2013 | K122890 | INION CPS ORBITAL PLATES Inion OY, FI | JEY |
| Feb 20, 2009 | K090177 | INION BIORESTORE BIODEGRADABLE BONE GRAFT SUBSTITUTE Inion OY, FI | MQV |
| Jul 11, 2008 | K071810 | INION SPINAL GRAFT CONTAINMENT SYSTEM Inion , Ltd., FI | OJB |
| Oct 11, 2007 | K070998 | INION BIORESTORE Inion OY, FI | MQV |
| Aug 3, 2007 | K071464 | INION HEXALON BIODEGRADABLE ACL/PCL SCREW Inion OY, FI | HWC |
| Jul 24, 2007 | K070784 | INION BIORESTORE Inion OY, FI | LYC |
| Jan 23, 2007 | K063410 | INION CPS/OTPS FREEDOMPLATE Inion , Ltd., FI | HRS |
| Nov 9, 2006 | K062782 | INION ANCHRON PLUS BIODEGRADABLE ANCHOR SYSTEM, MODEL ANC-6001 Inion OY, FI | MAI |
| Oct 4, 2006 | K062617 | MODIFICATION TO INION OTPS BIODEGRADABLE FIXATION SYSTEM Inion , Ltd., FI | HWC |
| Mar 13, 2006 | K060393 | INION HEXALON BIODEGRADABLE ACL/PCL SCREW Inion , Ltd., FI | HWC |
| Nov 25, 2005 | K051821 | INION S-1 BIODEGRADABLE ANTERIOR CERVICAL FUSION SYSTEM Inion , Ltd., FI | OJB |
| Nov 16, 2005 | K052624 | INION OTPS BIODEGRADABLE DISTAL RADIUS PLATE Inion , Ltd., FI | HRS |
| Sep 20, 2005 | K052444 | INION CPS BABY 1.5 BIOABSORBABLE FIXATION SYSTEM Inion , Ltd., FI | JEY |
| Aug 4, 2005 | K051362 | INION ANCHRON BIODEGRADABLE ANCHOR SYSTEM, MODEL ANC-6000 Inion OY, FI | MAI |
| May 27, 2005 | K051341 | INION CPS BABY 1.5 BIOABSORBABLE FIXATION SYSTEM, 40 AND 64 HOLE PLATES, MODELS PLT-1058 AND PLT-1059 Inion , Ltd., FI | JEY |
| Mar 7, 2005 | K050275 | MODIFICATION TO: INION OTPS BIODEGRADABLE PIN Inion , Ltd., FI | HTY |
| Feb 18, 2005 | K043142 | INION OTPS BIODEGRADABLE MINI PLATING SYSTEM Inion , Ltd., FI | HWC |
| Aug 16, 2004 | K031714 | INION TRINION BIODEGRADABLE MENISCUS SCREW Inion , Ltd., FI | HWC |
| Mar 31, 2004 | K033074 | INION GTR BIODEGRADABLE MEMBRANE SYSTEM Inion , Ltd., FI | NPK |
| Mar 1, 2004 | K031961 | INION OTPS BIODEGRADABLE MESH PLATING SYSTEM Inion , Ltd., FI | HRS |
| Oct 30, 2003 | K033194 | INION CPS BABY 1.5 BIOABSORBABLE SYSTEM Inion , Ltd., FI | JEY |
| Aug 28, 2003 | K031712 | INION OTPS BIODEGRADABLE PIN Inion , Ltd., FI | HTY |
| Jun 19, 2003 | K030900 | INION OTPS BIODEGRADABLE FIXATON SYSTEM Inion , Ltd., FI | HWC |
| May 30, 2003 | K023887 | INION OTPS BIODEGRADABLE MINI PLATING SYSTEM Inion , Ltd., FI | HWC |
| Sep 12, 2002 | K022981 | INION CPS 2.5/2.8 SCREW Inion , Ltd., FI | HWC |
| Jul 17, 2002 | K021280 | INION HEXALON BIODEGRADABLE ACL/PCL SCREW Inion , Ltd., FI | HWC |
| Feb 22, 2002 | K020266 | INION CPS BSSO SCREW Inion , Ltd., FI | HWC |
| Oct 5, 2001 | K013039 | INION CPS 2.0 ORTHOGNATHIC PLATE Inion , Ltd., FI | JEY |
| Mar 15, 2001 | K010351 | INION CPS BABY 1.5 BIOABSORBABLE FIXATION SYSTEM Inion , Ltd., FI | JEY |
| Mar 14, 2001 | K010352 | CPS 1.5/2.0/2.5 BIOABSORBABLE FIXATION SYSTEM Inion , Ltd., FI | JEY |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 1, 2017 | Inion Ltd. Inion GRT Tack, drill bit and tack appl., 4x, Sterile.
Is indicated for the surgical treatment of periodontal defects to aid in the regeneration and integration of tissue components in guided tissue Terminated |
NPK | K033074 |