Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) · Predicate Candidate Screening
15 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
87 daysmedian FDA review time
145 days90th percentile
15clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K201497 | EVOS Cabling System | Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) | 2020-10-28 | 145 | 0 |
| K200095 | Streamline Navigated Instruments | Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc. | 2020-06-26 | 162 | 3 |
| K193468 | Tritium Sternal Cable Plate System | Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) | 2020-03-12 | 87 | 0 |
| K192800 | Streamline TL Spinal Fixation System | Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) | 2020-01-14 | 106 | 0 |
| K192718 | Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D Te | Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc. | 2019-12-20 | 84 | 0 |
| K190498 | Fortilink® IBF System with TETRAfuse®3D Technology, include | Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc. | 2019-07-05 | 127 | 0 |
| K183060 | CervAlign™ Anterior Cervical Plate System | Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) | 2019-01-17 | 76 | 0 |
| K172139 | Streamline OCT Occipito-Cervico-Thoracic System | Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) | 2017-08-18 | 32 | 0 |
| K170830 | Unison-C Anterior Cervical Fixation System | Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc. | 2017-06-28 | 100 | 0 |
| K161876 | Tritium® Sternal Cable Plate System | Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc. | 2016-09-09 | 63 | 0 |
| K161498 | Streamline OCT Occipito-Cervico-Thoracic System | Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) | 2016-08-22 | 82 | 0 |
| K153735 | Release Laminoplasty Fixation System | Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) | 2016-01-21 | 24 | 0 |
| K152793 | Unison-C Anterior Cervical Fixation System | Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc. | 2016-01-19 | 113 | 0 |
| K150581 | Tritium Sternal Cable Plate System | Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) | 2015-06-04 | 87 | 0 |
| K150254 | Streamline OCT Occipito-Cervico-Thoracic System | Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) | 2015-04-28 | 84 | 2 |
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