Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Pioneer Surgical Technology, Inc. · Predicate Candidate Screening
27 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
83 daysmedian FDA review time
195 days90th percentile
27clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261271 | Cable-Ready® Cable Grip System | Pioneer Surgical Technology, Inc. | 2026-07-16 | 90 | 0 |
| K251436 | Resolve Anterior Cervical Plate System | Pioneer Surgical Technology, Inc. | 2025-07-11 | 64 | 0 |
| K222493 | CODA™ Anterior Cervical Plate System | Pioneer Surgical Technology, Inc. | 2022-11-18 | 92 | 0 |
| K211408 | CervAlign® Anterior Cervical Plate System | Pioneer Surgical Technology, Inc. | 2021-06-23 | 48 | 0 |
| K192396 | Streamline MIS Spinal Fixation System | Pioneer Surgical Technology, Inc. | 2019-11-26 | 84 | 0 |
| K140696 | STREAMLINE TL SPINAL FIXATION SYSTEM | Pioneer Surgical Technology, Inc. | 2014-04-10 | 22 | 0 |
| K133455 | CROSSFUSE II CORONAL TAPER, CROSSFUSE II HYPERLORDOTIC | Pioneer Surgical Technology, Inc. | 2014-03-27 | 135 | 1 |
| K133623 | C-PLUS | Pioneer Surgical Technology, Inc. | 2014-02-10 | 76 | 0 |
| K132050 | NB3D BONE VOID FILLER | Pioneer Surgical Technology, Inc. | 2014-02-07 | 220 | 1 |
| K133785 | TRITIUM STERNAL CABLE PLATE SYSTEM | Pioneer Surgical Technology, Inc. | 2014-01-27 | 46 | 1 |
| K131724 | PIONEER MAXFUSE VERTEBRAL BODY REPLACEMENT DEVICE | Pioneer Surgical Technology, Inc. | 2013-12-24 | 195 | 0 |
| K131100 | STREAMLINE TL SPINAL SYSTEM | Pioneer Surgical Technology, Inc. | 2013-06-27 | 69 | 0 |
| K130427 | PIONEER ASPECT ANTERIOR CERVICAL PLATE SYSTEM | Pioneer Surgical Technology, Inc. | 2013-06-05 | 105 | 0 |
| K130286 | STREAMLINE MIS SPINAL FIXATION SYSTEM | Pioneer Surgical Technology, Inc. | 2013-04-01 | 55 | 1 |
| K121725 | PIONEER POSTERIOR OCCIPITO-CERVICO-THORACIC (OCT) SYSTEM | Pioneer Surgical Technology, Inc. | 2012-11-07 | 148 | 0 |
| K122293 | PIONEER STERNAL CABLE PLATE SYSTEM | Pioneer Surgical Technology, Inc. | 2012-10-12 | 73 | 0 |
| K120016 | PIONEER STERNAL ASSIST IMPLANT SYSTEM | Pioneer Surgical Technology, Inc. | 2012-07-26 | 205 | 0 |
| K120724 | PIONEER LATERAL PLATE SYSTEM | Pioneer Surgical Technology, Inc. | 2012-05-07 | 59 | 0 |
| K112757 | PIONEER POSTERIOR CERVICO THORACIC SYSTEM | Pioneer Surgical Technology, Inc. | 2012-03-12 | 172 | 1 |
| K113218 | PIONEER RELEASE LAMINOPLASTY PLATING SYSTEM | Pioneer Surgical Technology, Inc. | 2012-01-26 | 86 | 0 |
| K111944 | NB3D BONE VOID FILLER | Pioneer Surgical Technology, Inc. | 2011-11-22 | 137 | 0 |
| K112496 | PIONEER CROSSFUSE II IBF/VBR SYSTEM | Pioneer Surgical Technology, Inc. | 2011-09-28 | 30 | 0 |
| K111528 | PIONEER ASPECT ANTERIOR CERVICAL PLATE MODEL 24-SERIES | Pioneer Surgical Technology, Inc. | 2011-08-24 | 83 | 0 |
| K111502 | STREAMLINE TL SPINAL SYSTEM | Pioneer Surgical Technology, Inc. | 2011-08-23 | 84 | 0 |
| K110692 | STREAMLINE TL SPINAL SYSTEM | Pioneer Surgical Technology, Inc. | 2011-05-12 | 62 | 0 |
| K110367 | PIONEER SPINAL PROCESS FUSION PLATE | Pioneer Surgical Technology, Inc. | 2011-03-23 | 43 | 0 |
| K102903 | PIONEER CANNULATED SCREW SYSTEM | Pioneer Surgical Technology, Inc. | 2010-10-20 | 20 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda