Orthohelix Surgical Designs, Inc.: FDA filings under this applicant name
FDA lists 25 510(k) clearances under the applicant name “Orthohelix Surgical Designs, Inc.” (first 2005, latest 2014), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 62 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 | 6 | 73 |
| 2013 | 3 | 29 |
| 2014 | 4 | 88 |
| 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 |
|---|---|---|---|
| HRS | Plate, Fixation, Bone | 17 | 17 |
| HWC | Screw, Fixation, Bone | 3 | 3 |
| HTY | Pin, Fixation, Smooth | 2 | 2 |
| JDR | Staple, Fixation, Bone | 2 | 2 |
| HTN | Washer, Bolt Nut | 1 | 1 |
Review panels
- Orthopedic (25)
Most recent Orthohelix Surgical Designs, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K142148 | ORTHOHELIX STAPLE SYSTEM | JDR | 2014-08-21 | 16 |
| K141004 | INTRAOSSEOUS FIXATION SYSTEM | HTY | 2014-08-21 | 125 |
| K141301 | MAXLOCK EXTREME ELBOW FRACTURE SYSTEM | HRS | 2014-07-11 | 53 |
| K132733 | ORTHOHELIX SYNDESMOSIS FIXATION DEVICES | HTN | 2014-01-03 | 122 |
| K132591 | MAXLOCK EXTREME SYSTEM | HRS | 2013-09-17 | 29 |
| K130832 | ORTHOHELIX STAPLE SYSTEM | JDR | 2013-08-15 | 142 |
| K131324 | MAXTORQUE SCREW SYSTEM | HWC | 2013-05-31 | 23 |
| K123203 | MAXLOCK EXTREME SYSTEM MODEL MXL | HRS | 2012-12-14 | 63 |
| K122005 | MAXLOCK EXTREME SYSTEM | HRS | 2012-09-06 | 59 |
| K121437 | MINI MAXLOCK EXTREME PLATING SYSTEM | HRS | 2012-06-13 | 29 |
15 earlier clearances. See the full list in Caduvo.
Recalls
16 product recalls in 13 recall events; 0 initiated in the last five years. Most recent: 2014-09-19.
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 Orthohelix Surgical Designs, Inc.?
FDA lists 25 510(k) clearances under the applicant name “Orthohelix Surgical Designs, Inc.” (first 2005, latest 2014), across 5 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Orthohelix Surgical Designs, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Orthohelix Surgical Designs, Inc. is 62 days.
Which FDA product codes appear under Orthohelix Surgical Designs, Inc.?
The most frequent FDA product codes under this applicant name are HRS (Plate, Fixation, Bone, 17); HWC (Screw, Fixation, Bone, 3); HTY (Pin, Fixation, Smooth, 2).
Next steps
- See all 25 Orthohelix Surgical Designs, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HRS, Orthohelix Surgical Designs, 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.