Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.” (first 2016, latest 2020), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 113 days. Since 2017 the median was 127 days, against 96 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 |
|---|---|---|
| 2016 | 2 | 88 |
| 2017 | 1 | 100 |
| 2018 | 0 | — |
| 2019 | 2 | 106 |
| 2020 | 2 | 152 |
| 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 Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc. took a median 127 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 96 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | 2 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | 2 | 2 |
| HRS | Plate, Fixation, Bone | 1 | 1 |
| JDQ | Cerclage, Fixation | 1 | 1 |
| OLO | Orthopedic Stereotaxic Instrument | 1 | 1 |
Review panels
- Orthopedic (7)
Most recent Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K200513 | DAC Dynamic Active Compression Plate | HRS | 2020-07-22 | 142 |
| K200095 | Streamline Navigated Instruments | OLO | 2020-06-26 | 162 |
| K192718 | Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D Technology | MAX | 2019-12-20 | 84 |
| K190498 | Fortilink® IBF System with TETRAfuse®3D Technology, include the following designs: Fortilink®-TS IBF System, Fortilink®-L I BF System, Fortilink®-C IBF System | MAX | 2019-07-05 | 127 |
| K170830 | Unison-C Anterior Cervical Fixation System | OVE | 2017-06-28 | 100 |
| K161876 | Tritium® Sternal Cable Plate System | JDQ | 2016-09-09 | 63 |
| K152793 | Unison-C Anterior Cervical Fixation System | OVE | 2016-01-19 | 113 |
Recalls
openFDA lists no recalls under a recalling firm named Pioneer Surgical Technology, Inc., Dba Rti Surgical, 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.
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.
- Pioneer Surgical Technology (77 510(k)s)
- Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) (9 510(k)s)
- Pioneer Viggo, Inc. (6 510(k)s)
- Pioneer Medical, Inc. (2 510(k)s)
- Pioneer Sundries Products , Ltd. (2 510(k)s)
- Pioneer Surgical Technology, Inc D.B.A Resolve Surgical Tech (2 510(k)s)
- Pioneer Surgical Technology, Inc. (Rti Surgical, I (2 510(k)s)
- Pioneer Intl. Co. (1 510(k)s)
- Pioneer Surgical Technology, Inc. (Rti Surgical, Inc.) (1 510(k)s)
- Pioneer Trading Co. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.?
FDA lists 7 510(k) clearances under the applicant name “Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.” (first 2016, latest 2020), 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 Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc. is 113 days. Since 2017: 127 days, versus 96 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.?
The most frequent FDA product codes under this applicant name are MAX (Intervertebral Fusion Device With Bone Graft, Lumbar, 2); OVE (Intervertebral Fusion Device With Integrated Fixation, Cervical, 2); HRS (Plate, Fixation, Bone, 1).
Next steps
- See all 7 Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MAX, Pioneer Surgical Technology, Inc., Dba Rti Surgical, 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.