# Isotis Orthobiologics, Inc.

- Location (FDA's records): Irvine, CA
- FDA decisions: 10 (2004–2009): 10 510(k) clearances
- Product codes: MQV (4), MBP (3), LYC (1), NUN (1), FMF (1)
- Predicates its devices cite: 22 (7 its own); citations of its devices by later devices: 25 (7 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Wrightmedicaltechnologyinc: 3 (https://510kreport.com/company/wrightmedicaltechnologyinc)
- Interpore Cross Intl.: 2 (https://510kreport.com/company/interpore-cross-intl)
- Isotis NV: 2 (https://510kreport.com/company/isotis)
- Osteotech, Inc.: 2 (https://510kreport.com/company/osteotech)
- Interpore Intl.: 1 (https://510kreport.com/company/interpore-intl)
- Geistlich Pharma AG: 1 (https://510kreport.com/company/geistlich-pharma)
- Biocoll Laboratories, Inc.: 1 (https://510kreport.com/company/biocoll-laboratories)
- Musculoskeletal Transplant Foundation: 1 (https://510kreport.com/company/musculoskeletal-transplant-foundation)

## Firms that cite its devices most
- Allosource, Inc.: 3 (https://510kreport.com/company/allosource)
- Isotis NV: 3 (https://510kreport.com/company/isotis)
- Intra-Lock International: 2 (https://510kreport.com/company/intra-lock-international)
- Medtronic Sofamor Danek: 1 (https://510kreport.com/company/medtronic-sofamor-danek)
- Biomatlante: 1 (https://510kreport.com/company/biomatlante)
- Exactech, Inc.: 1 (https://510kreport.com/company/exactech)
- Revisios BV: 1 (https://510kreport.com/company/revisios)
- Hans Biomed Corporation: 1 (https://510kreport.com/company/hans-biomed)

## Its most-cited devices
- K040419: Dynagraft II (2005), cited by 8
- K042706: Ossatura Dental (2004), cited by 4
- K050642: Orthoblast II Putty and Paste (2005), cited by 4
- K041991: Aspirex - Bone Marrow Aspirate Kit (2004), cited by 3
- K043573: Dynagraft II Dental (2005), cited by 2
- K050690: Connexus (2005), cited by 2

## Recent decisions
- K091193: Accell EVO3C (Aug 10, 2009)
- K081817: Accell TBM-R (Sep 24, 2008)
- K070751: Orthoblast II DBM Demineralized Bone Matrix Paste and Putty (Oct 15, 2007)
- K050642: Orthoblast II Putty and Paste (Dec 5, 2005)
- K052098: Connexus, .5CC, Model 023000-005 (Sep 7, 2005)
- K043573: Dynagraft II Dental (Jul 29, 2005)
- K050690: Connexus (Jul 7, 2005)
- K040419: Dynagraft II (Mar 25, 2005)

Source page: https://510kreport.com/company/isotis-orthobiologics