IsoTis OrthoBiologics, Inc.
Irvine, CA, US
ISOTIS ORTHOBIOLOGICS, INC appears in FDA device records in Irvine, CA. FDA records list 10 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 3 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 10 510(k) clearances for IsoTis OrthoBiologics, Inc. between 2004 and 2009. The busiest year on record is 2005, with 5. The most recent is 2009, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2004 | 2 |
| 2005 | 5 |
| 2007 | 1 |
| 2008 | 1 |
| 2009 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K091193 | ACCELL EVO3C | MBP | Substantially Equivalent | |
| K081817 | ACCELL TBM-R | MBP | Substantially Equivalent | |
| K070751 | ORTHOBLAST II DBM DEMINERALIZED BONE MATRIX PASTE AND PUTTY | MQV | Substantially Equivalent | |
| K050642 | ORTHOBLAST II PUTTY AND PASTE | MBP | Substantially Equivalent | |
| K052098 | CONNEXUS, .5CC, MODEL 023000-005 | MQV | Substantially Equivalent | |
| K043573 | DYNAGRAFT II DENTAL | NUN | Substantially Equivalent | |
| K050690 | CONNEXUS | MQV | Substantially Equivalent | |
| K040419 | DYNAGRAFT II | MQV | Substantially Equivalent | |
| K042706 | OSSATURA DENTAL | LYC | Substantially Equivalent | |
| K041991 | ASPIREX - BONE MARROW ASPIRATE KIT | FMF | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2090010 | 3001503333 | ISOTIS ORTHOBIOLOGICS, INC | 2 Goodyear, IRVINE, CA 92618 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2820-2026 | OsteoBallast, 45 x 17.5 mm (SeaSpine Brand), REF: 56800095. Ballast, 45 x 17.5 mm (IsoTis Brand), REF: 02-8000-095 | Demineralized bone matrix (DBM) in resorbable mesh indicated for use with autograft as a bone graft extender in the posterolateral spine and pelvis, were filled with approx. 4.5 cc DBM (fill for 45 11 mm configuration) instead of approx. 7.5 cc DBM (fill for 45 17.5 mm configuration), which may lead to delayed fusion, incomplete fusion, pseudarthrosis, or lack of bone ingrowth. | Class II | Open, Classified | |
| Z-0955-2025 | OsteoSurge 100 Demineralized Bone Matrix Putty with Accell Bone Matrix, OsteoSurge 100 Demineralized Bone Matrix, 10cc, REF 56300100. | Incorrect expiration date listed on the outer box, which does not align with the correct expiration date listed on the inner tray. | Class II | Open, Classified | |
| Z-0919-2025 | OsteoCove Putty, 1.25cc, REF 56920013 and Cove Putty, 1.25cc REF 02-9200-01. | Hydration issue resulting in the product being less cohesive and moldable than intended due to an issue with the polymer. | Class II | Open, Classified |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain