Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.): FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)” (first 2015, latest 2020), across 6 product codes in 1 review panel. Median 510(k) review time under this name: 84 days. Since 2017 the median was 87 days, against 68 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 |
|---|---|---|
| 2015 | 2 | 86 |
| 2016 | 2 | 53 |
| 2017 | 1 | 32 |
| 2018 | 0 | — |
| 2019 | 1 | 76 |
| 2020 | 3 | 106 |
| 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 87 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 68 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JDQ | Cerclage, Fixation | 3 | 3 |
| NKG | Posterior Cervical Screw System | 2 | 2 |
| KWP | Appliance, Fixation, Spinal Interlaminal | 1 | 1 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 1 | 1 |
| NKB | Thoracolumbosacral Pedicle Screw System | 1 | 1 |
| NQW | Orthosis, Spine, Plate, Laminoplasty, Metal | 1 | 1 |
Review panels
- Orthopedic (9)
Most recent Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K201497 | EVOS Cabling System | JDQ | 2020-10-28 | 145 |
| K193468 | Tritium Sternal Cable Plate System | JDQ | 2020-03-12 | 87 |
| K192800 | Streamline TL Spinal Fixation System | NKB | 2020-01-14 | 106 |
| K183060 | CervAlign Anterior Cervical Plate System | KWQ | 2019-01-17 | 76 |
| K172139 | Streamline OCT Occipito-Cervico-Thoracic System | NKG | 2017-08-18 | 32 |
| K161498 | Streamline OCT Occipito-Cervico-Thoracic System | NKG | 2016-08-22 | 82 |
| K153735 | Release Laminoplasty Fixation System | NQW | 2016-01-21 | 24 |
| K150581 | Tritium Sternal Cable Plate System | JDQ | 2015-06-04 | 87 |
| K150254 | Streamline OCT Occipito-Cervico-Thoracic System | KWP | 2015-04-28 | 84 |
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. (7 510(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 9 510(k) clearances under the applicant name “Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)” (first 2015, latest 2020), across 6 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 84 days. Since 2017: 87 days, versus 68 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 JDQ (Cerclage, Fixation, 3); NKG (Posterior Cervical Screw System, 2); KWP (Appliance, Fixation, Spinal Interlaminal, 1).
Next steps
- See all 9 Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) clearances with predicates and recalls
- Run predicate analysis for product code JDQ, 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.