Isotis Orthobiologics, Inc.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Isotis Orthobiologics, Inc.” (first 2004, latest 2009), across 5 product codes in 3 review panels. Median 510(k) review time under this name: 110 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MQV | Filler, Bone Void, Calcium Compound | 4 | 4 |
| MBP | Filler, Bone Void, Osteoinduction (W/O Human Growth Factor) | 3 | 3 |
| FMF | Syringe, Piston | 1 | 1 |
| LYC | Bone Grafting Material, Synthetic | 1 | 1 |
| NUN | Bone Grafting Material, Human Source | 1 | 1 |
Review panels
- Orthopedic (7)
- Dental (2)
- General Hospital (1)
Most recent Isotis Orthobiologics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K091193 | ACCELL EVO3C | MBP | 2009-08-10 | 109 |
| K081817 | ACCELL TBM-R | MBP | 2008-09-24 | 90 |
| K070751 | ORTHOBLAST II DBM DEMINERALIZED BONE MATRIX PASTE AND PUTTY | MQV | 2007-10-15 | 210 |
| K050642 | ORTHOBLAST II PUTTY AND PASTE | MBP | 2005-12-05 | 269 |
| K052098 | CONNEXUS, .5CC, MODEL 023000-005 | MQV | 2005-09-07 | 35 |
| K043573 | DYNAGRAFT II DENTAL | NUN | 2005-07-29 | 214 |
| K050690 | CONNEXUS | MQV | 2005-07-07 | 112 |
| K040419 | DYNAGRAFT II | MQV | 2005-03-25 | 401 |
| K042706 | OSSATURA DENTAL | LYC | 2004-10-20 | 20 |
| K041991 | ASPIREX - BONE MARROW ASPIRATE KIT | FMF | 2004-09-16 | 55 |
Recalls
3 product recalls in 3 recall events; 3 initiated in the last five years. Most recent: 2026-07-02.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Isotis Orthobiologics, Inc. (a text match, not an official crosswalk):
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Isotis NV (8 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Isotis Orthobiologics, Inc.?
FDA lists 10 510(k) clearances under the applicant name “Isotis Orthobiologics, Inc.” (first 2004, latest 2009), across 5 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Isotis Orthobiologics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Isotis Orthobiologics, Inc. is 110 days.
Which FDA product codes appear under Isotis Orthobiologics, Inc.?
The most frequent FDA product codes under this applicant name are MQV (Filler, Bone Void, Calcium Compound, 4); MBP (Filler, Bone Void, Osteoinduction (W/O Human Growth Factor), 3); FMF (Syringe, Piston, 1).
Next steps
- See all 10 Isotis Orthobiologics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MQV, Isotis Orthobiologics, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.