Orthovita, Inc.: FDA filings under this applicant name
FDA lists 26 510(k) clearances under the applicant name “Orthovita, Inc.” (first 1995, latest 2017), across 9 product codes in 5 review panels. Median 510(k) review time under this name: 96 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 | 2 | 52 |
| 2015 | 1 | 32 |
| 2016 | 2 | 96 |
| 2017 | 1 | 131 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Orthovita, Inc. took a median 131 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 124 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MQV | Filler, Bone Void, Calcium Compound | 12 | 12 |
| FMF | Syringe, Piston | 4 | 4 |
| LYC | Bone Grafting Material, Synthetic | 3 | 3 |
| KNW | Instrument, Biopsy | 2 | 2 |
| HAW | Neurological Stereotaxic Instrument | 1 | 1 |
| LXH | Orthopedic Manual Surgical Instrument | 1 | 1 |
| MQP | Spinal Vertebral Body Replacement Device | 1 | 1 |
| NDN | Cement, Bone, Vertebroplasty | 1 | 1 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 1 | 1 |
Review panels
- Orthopedic (16)
- General Hospital (4)
- Dental (3)
- General and Plastic Surgery (2)
- Neurology (1)
Most recent Orthovita, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K163621 | Vitoss Bioactive (BA) Injectable | MQV | 2017-05-02 | 131 |
| K161447 | HydroSet XT | MQV | 2016-10-06 | 134 |
| K153608 | Vitoss BiModal Bone Graft Substitute Foam Strip | MQV | 2016-02-12 | 57 |
| K153306 | Imbibe Needle | KNW | 2015-12-18 | 32 |
| K140868 | STRYKER KWIC NEEDLE | HAW | 2014-06-05 | 63 |
| K140414 | IMBIBE NEEDLE | LXH | 2014-04-01 | 42 |
| K103173 | VITOSS BA BIMODAL BIOACTIVE BONE GRAFT SUBSTITUTE | MQV | 2011-02-07 | 102 |
| K101171 | ORTHOVITA PEEK SPACER | ODP | 2011-01-25 | 274 |
| K102545 | FM-02 BONE GRAFT SUBSTITUTE | MQV | 2010-10-27 | 54 |
| K091618 | VITOMATRIX | LYC | 2010-09-27 | 481 |
16 earlier clearances. See the full list in Caduvo.
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2011-03-31.
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Orthovita, Inc.?
FDA lists 26 510(k) clearances under the applicant name “Orthovita, Inc.” (first 1995, latest 2017), across 9 product codes in 5 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 Orthovita, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Orthovita, Inc. is 96 days.
Which FDA product codes appear under Orthovita, Inc.?
The most frequent FDA product codes under this applicant name are MQV (Filler, Bone Void, Calcium Compound, 12); FMF (Syringe, Piston, 4); LYC (Bone Grafting Material, Synthetic, 3).
Next steps
- See all 26 Orthovita, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MQV, Orthovita, 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.