Rti Biologics, Inc.
FDA Regulatory Profile
Rti Biologics, Inc. has 3 FDA recalls, 10 inspections, 12 510(k) clearances and 2 compliance actions on record.
- Latest recall
- Z-1441-2017 · Class II · Jan 23, 2017
- Latest inspection
- Jan 30, 2026 · VAI
- Latest 510(k)
- Oct 22, 2025
Reviewing Rti Biologics, Inc. as a supplier? Request a free FDA snapshot: name up to five suppliers and get a PDF of their public FDA record, with sources and dates. You do not need an API connection. Each snapshot is prepared by hand.
Request a free FDA snapshot
Or get Rti Biologics, Inc.'s full FDA risk summary, with inspections, warning letters, Form 483s and import alerts by site, in Claude, Cursor or ChatGPT.
Get a free API key
Summary
Record counts and when each FDA source was last refreshed
| Records | Count | Last refreshed | Source as of | Status |
|---|
| Recalls | 3 | Oct 23, 2026 | Not stated | Current |
|---|
| 510(k) clearances | 12 | Oct 4, 2026 | Not stated | Current |
|---|
| Inspections | 10 | Oct 26, 2026 | Not stated | Current |
|---|
| Compliance actions | 2 | Oct 23, 2026 | Not stated | Current |
|---|
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1441-2017 | Class II | RTI Biologics BioSet IC RT Paste 2 cc Filler, bone void, calcium compound. Use in dental, spine… | Jan 23, 2017 |
| Z-0939-2014 | Class II | ***REF 606-01-05***OPTEFORM Allograft Paste 5 cc, bone void filler of bony defects in dental and… | Dec 6, 2013 |
| Z-0627-2014 | Class II | C-Plus" 10mm x 12mm Webless implants Pioneer Surgical's C-Plus " 10mm x 12mm Webless implants are… | Oct 7, 2013 |
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|
| Jan 30, 2026 | Alachua, FL | Biologics | Voluntary Action Indicated (VAI) | 3002719998 |
| Feb 7, 2023 | Alachua, FL | Biologics | No Action Indicated (NAI) | 3002719998 |
| Mar 7, 2019 | Alachua, FL | Biologics | No Action Indicated (NAI) | 3002719998 |
| Aug 28, 2018 | Alachua, FL | Biologics | Official Action Indicated (OAI) | 3002719998 |
| Jun 10, 2016 | Alachua, FL | Biologics | No Action Indicated (NAI) | 3002719998 |
| Jan 9, 2014 | Allendale, NJ | Biologics | Voluntary Action Indicated (VAI) | 3010125299 |
| Sep 10, 2013 | Alachua, FL | Biologics | No Action Indicated (NAI) | 3002719998 |
| Jul 11, 2012 | Alachua, FL | Biologics | Official Action Indicated (OAI) | 3002719998 |
| Oct 25, 2011 | Alachua, FL | Biologics | Voluntary Action Indicated (VAI) | 3002719998 |
| Oct 15, 2010 | Alachua, FL | Biologics | Voluntary Action Indicated (VAI) | 3002719998 |
NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K253145 | Pre-Sutured Tendon | Oct 22, 2025 |
| K241555 | Moldable Bone Void Filler and Moldable Bone Void Filler + CCC | Feb 21, 2025 |
| K230036 | Pre-Sutured Tendon (4561SC / Single Strand); Pre-Sutured Tendon (4564SC / Quadruple Strand ) | Jun 23, 2023 |
| K172343 | Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D Technology | Oct 23, 2017 |
| K163673 | Fortilink-C with TETRAfuse 3D Technology | May 23, 2017 |
| K170643 | Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) System | Apr 14, 2017 |
| K150521 | Interbody Fusion (IBF)/Vertebral Body Replacement(VBR) System | May 15, 2015 |
| K142070 | FORTIVA PORCINE DERMIS, TUTOPLAST PORCINE DERMIS | Oct 27, 2014 |
| K132850 | BOVINE PERICARDIUM SUTURABLE DURAL GRAFT, TUTOPATCH DM GRAFT, TUTOPLAST BOVINE PERICARDIUM DM | Mar 31, 2014 |
| K123356 | FORTIVA PORCINE DERMIS | Mar 5, 2013 |
| K091142 | TUTOPATCH, TUTOMESH, MODELS 68350, 68351, 68352, 68353, 68354, 68355, 68356, 68357, 68358 | Aug 31, 2009 |
| K081538 | TUTOPATCH, TUTOMESH | Jun 19, 2008 |