Pioneer Surgical Technology: FDA filings under this applicant name
FDA lists 77 510(k) clearances under the applicant name “Pioneer Surgical Technology” (first 1993, latest 2026), across 18 product codes in 3 review panels. Median 510(k) review time under this name: 86 days. Since 2017 the median was 84 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 | 6 | 117 |
| 2013 | 4 | 87 |
| 2014 | 5 | 76 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 1 | 84 |
| 2020 | 0 | — |
| 2021 | 1 | 48 |
| 2022 | 1 | 92 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 1 | 64 |
| 2026 | 1 | 90 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Pioneer Surgical Technology took a median 84 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 |
|---|---|---|---|
| JDQ | Cerclage, Fixation | 13 | 13 |
| NKB | Thoracolumbosacral Pedicle Screw System | 13 | 13 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 12 | 12 |
| MQV | Filler, Bone Void, Calcium Compound | 7 | 7 |
| HWC | Screw, Fixation, Bone | 6 | 6 |
| KWP | Appliance, Fixation, Spinal Interlaminal | 5 | 5 |
| HRS | Plate, Fixation, Bone | 3 | 3 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 3 | 3 |
| MNI | Orthosis, Spinal Pedicle Fixation | 3 | 3 |
| MQP | Spinal Vertebral Body Replacement Device | 3 | 3 |
Plus 8 more product codes.
Review panels
- Orthopedic (75)
- Neurology (1)
- General and Plastic Surgery (1)
Most recent Pioneer Surgical Technology 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K261271 | Cable-Ready® Cable Grip System | JDQ | 2026-07-16 | 90 |
| K251436 | Resolve Anterior Cervical Plate System | KWQ | 2025-07-11 | 64 |
| K222493 | CODA Anterior Cervical Plate System | KWQ | 2022-11-18 | 92 |
| K211408 | CervAlign® Anterior Cervical Plate System | KWQ | 2021-06-23 | 48 |
| K192396 | Streamline MIS Spinal Fixation System | NKB | 2019-11-26 | 84 |
| K140696 | STREAMLINE TL SPINAL FIXATION SYSTEM | NKB | 2014-04-10 | 22 |
| K133455 | CROSSFUSE II CORONAL TAPER, CROSSFUSE II HYPERLORDOTIC | MAX | 2014-03-27 | 135 |
| K133623 | C-PLUS | ODP | 2014-02-10 | 76 |
| K132050 | NB3D BONE VOID FILLER | MQV | 2014-02-07 | 220 |
| K133785 | TRITIUM STERNAL CABLE PLATE SYSTEM | JDQ | 2014-01-27 | 46 |
67 earlier clearances. See the full list in Caduvo.
Recalls
10 product recalls in 9 recall events; 0 initiated in the last five years. Most recent: 2014-06-11.
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.
Device clinical trials
An industry sponsor named Pioneer Surgical Technology is the lead sponsor of 3 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT01829997: Assessment of nanOss Bioactive 3D in the Posterolateral Spine (Completed, started 2013-04)
- NCT01968993: Comparison of nanOss Bioactive With Autograft and Bone Marrow Aspirate to Autograft in the Posterolateral Spine (Completed, started 2010-01)
- NCT00931515: Trial Evaluating the Safety and Effectiveness of NUBAC™ Disc Arthroplasty (Completed, started 2009-02)
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, Inc. (Dba Rti Surgical, Inc.) (9 510(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?
FDA lists 77 510(k) clearances under the applicant name “Pioneer Surgical Technology” (first 1993, latest 2026), across 18 product codes in 3 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 Pioneer Surgical Technology?
The median time from FDA receipt to decision across 510(k)s cleared under the name Pioneer Surgical Technology is 86 days. Since 2017: 84 days, versus 98 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Pioneer Surgical Technology?
The most frequent FDA product codes under this applicant name are JDQ (Cerclage, Fixation, 13); NKB (Thoracolumbosacral Pedicle Screw System, 13); KWQ (Appliance, Fixation, Spinal Intervertebral Body, 12).
Next steps
- See all 77 Pioneer Surgical Technology clearances with predicates and recalls
- Run predicate analysis for product code JDQ, Pioneer Surgical Technology'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.