Orthocon, Inc.: FDA filings under this applicant name
FDA lists 40 510(k) clearances under the applicant name “Orthocon, Inc.” (first 2005, latest 2026), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 114 days. Since 2017 the median was 94 days, against 98 days for all cleared 510(k)s in the same product codes. 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 | 3 | 141 |
| 2013 | 2 | 181 |
| 2014 | 4 | 46 |
| 2015 | 1 | 87 |
| 2016 | 1 | 378 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 1 | 79 |
| 2020 | 1 | 147 |
| 2021 | 1 | 153 |
| 2022 | 1 | 36 |
| 2023 | 8 | 132 |
| 2024 | 6 | 90 |
| 2025 | 0 | — |
| 2026 | 6 | 47 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Orthocon, Inc. took a median 94 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 98 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MTJ | Wax, Bone | 24 | 24 |
| GXP | Methyl Methacrylate For Cranioplasty | 7 | 7 |
| MQV | Filler, Bone Void, Calcium Compound | 7 | 7 |
| GXR | Cover, Burr Hole | 1 | 1 |
| MBP | Filler, Bone Void, Osteoinduction (W/O Human Growth Factor) | 1 | 1 |
Review panels
- Orthopedic (32)
- Neurology (8)
Most recent Orthocon, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K262769 | Permatage XT Settable Nonabsorbable Hemostatic Bone Putty (OS-PER-1001XT) | MTJ | 2026-09-03 | 30 |
| K261265 | Permatage XT Settable Bone Putty | GXP | 2026-06-15 | 60 |
| K261439 | Permatage Flowable, Settable Hemostatic Bone Paste | MTJ | 2026-06-03 | 34 |
| K253447 | Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover) | GXR | 2026-03-16 | 165 |
| K253732 | Permatage Flowable, Settable Bone Paste | GXP | 2026-03-13 | 109 |
| K253854 | MONTAGE XT Cranial Cement | GXP | 2026-01-02 | 30 |
| K243526 | MONTAGE Settable, Resorbable Bone Putty MONTAGE-QS Settable, Resorbable Bone Putty MONTAGE Flowable Settable, Resorbable Bone Paste MONTAGE-XT Settable, Resorbable Hemostatic Bone Putty | MQV | 2024-12-05 | 21 |
| K243506 | Montage-XT Settable Bone Putty | MQV | 2024-11-18 | 6 |
| K241027 | Permatage Settable Bone Putty | GXP | 2024-09-26 | 164 |
| K233566 | Montage-XT Settable, Resorbable Bone Putty | MQV | 2024-08-21 | 289 |
30 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Orthocon, Inc..
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 Orthocon, Inc. (a text match, not an official crosswalk):
Frequently asked questions
How many FDA 510(k) clearances are listed under Orthocon, Inc.?
FDA lists 40 510(k) clearances under the applicant name “Orthocon, Inc.” (first 2005, latest 2026), across 5 product codes in 2 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 Orthocon, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Orthocon, Inc. is 114 days. Since 2017: 94 days, versus 98 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Orthocon, Inc.?
The most frequent FDA product codes under this applicant name are MTJ (Wax, Bone, 24); GXP (Methyl Methacrylate For Cranioplasty, 7); MQV (Filler, Bone Void, Calcium Compound, 7).
Next steps
- See all 40 Orthocon, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MTJ, Orthocon, 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.