IsoTis OrthoBiologics, Inc.
FDA Regulatory Profile
IsoTis OrthoBiologics, Inc. appears in FDA public data with 3 recalls, 10 510(k) clearances, 4 FDA inspections, and 1 compliance action on record. Its most recent recall (Z-2820-2026, Class II) was initiated on July 2, 2026. Its most recent 510(k) clearance was granted on August 10, 2009.
Summary
- Total Recalls
- 3
- 510(k) Clearances
- 10
- Inspections
- 4
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2820-2026 | Class II | OsteoBallast, 45 x 17.5 mm (SeaSpine Brand), REF: 56800095. Ballast, 45 x 17.5 mm (IsoTis Brand), R | July 2, 2026 |
| Z-0955-2025 | Class II | OsteoSurge 100 Demineralized Bone Matrix Putty with Accell Bone Matrix, OsteoSurge 100 Demineralized | November 27, 2024 |
| Z-0919-2025 | Class II | OsteoCove Putty, 1.25cc, REF 56920013 and Cove Putty, 1.25cc REF 02-9200-01. | November 27, 2024 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K091193 | ACCELL EVO3C | August 10, 2009 |
| K081817 | ACCELL TBM-R | September 24, 2008 |
| K070751 | ORTHOBLAST II DBM DEMINERALIZED BONE MATRIX PASTE AND PUTTY | October 15, 2007 |
| K050642 | ORTHOBLAST II PUTTY AND PASTE | December 5, 2005 |
| K052098 | CONNEXUS, .5CC, MODEL 023000-005 | September 7, 2005 |
| K043573 | DYNAGRAFT II DENTAL | July 29, 2005 |
| K050690 | CONNEXUS | July 7, 2005 |
| K040419 | DYNAGRAFT II | March 25, 2005 |
| K042706 | OSSATURA DENTAL | October 20, 2004 |
| K041991 | ASPIREX - BONE MARROW ASPIRATE KIT | September 16, 2004 |