# Isotis NV

- Location (FDA's records): North Attleboro, MA
- FDA decisions: 8 (2000–2007): 8 510(k) clearances
- Product codes: MQV (2), NUN (2), LZN (2), FMF (1), LYC (1)
- Predicates its devices cite: 12 (1 its own); citations of its devices by later devices: 14 (1 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Isotis Orthobiologics, Inc.: 3 (https://510kreport.com/company/isotis-orthobiologics)
- Interpore Intl.: 3 (https://510kreport.com/company/interpore-intl)
- Wrightmedicaltechnologyinc: 1 (https://510kreport.com/company/wrightmedicaltechnologyinc)
- Interpore Cross Intl.: 1 (https://510kreport.com/company/interpore-cross-intl)
- Regeneration Technologies, Inc.: 1 (https://510kreport.com/company/regeneration-technologies)
- Orthovita, Inc.: 1 (https://510kreport.com/company/orthovita)
- Geistlich Pharma AG: 1 (https://510kreport.com/company/geistlich-pharma)

## Firms that cite its devices most
- Apatech, Ltd.: 3 (https://510kreport.com/company/apatech)
- Isotis Orthobiologics, Inc.: 2 (https://510kreport.com/company/isotis-orthobiologics)
- Smith & Nephew, Inc.: 2 (https://510kreport.com/company/smith-nephew)
- Integra Life Sciences: 1 (https://510kreport.com/company/integra-life-sciences)
- Medical Biomat: 1 (https://510kreport.com/company/medical-biomat)
- Progentix Orthobiology BV: 1 (https://510kreport.com/company/progentix-orthobiology)
- Xpand Biotechnology BV: 1 (https://510kreport.com/company/xpand-biotechnology)
- The Straumann Co.: 1 (https://510kreport.com/company/straumann)

## Its most-cited devices
- K030131: Ossatura BCP Bone Void Filler (2003), cited by 6
- K061880: Acceli DBM Family Products, 0.5CC, 1CC, 2.5CC, 5CC, 10CC, 15CC, 30CC (2007), cited by 3
- K000587: Shuttle Stop (2000), cited by 2
- K060306: Accell Connexus Demineralized Bone Matrix Putty (2006), cited by 1
- K031813: Ossatura Dental (2004), cited by 1
- K010840: Synplug (2001), cited by 1

## Recent decisions
- K061880: Acceli DBM Family Products, 0.5CC, 1CC, 2.5CC, 5CC, 10CC, 15CC, 30CC (Aug 15, 2007)
- K060332: Orthoblast II DBM Demineralized Bone Matrix  Paste and Putty (Mar 29, 2006)
- K060306: Accell Connexus Demineralized Bone Matrix Putty (Mar 27, 2006)
- K031813: Ossatura Dental (Aug 20, 2004)
- K041344: Open Bore Syringe (Jul 16, 2004)
- K030131: Ossatura BCP Bone Void Filler (May 20, 2003)
- K010840: Synplug (Apr 20, 2001)
- K000587: Shuttle Stop (May 4, 2000)

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