Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Pioneer Surgical Technology · Predicate Candidate Screening
50 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
87 daysmedian FDA review time
252 days90th percentile
50clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K110561 | FORTROSS BONE VOID FILLER | Pioneer Surgical Technology | 2011-04-29 | 60 | 0 |
| K101790 | QUANTUM SPINAL SYSTEM, QUANTUM MIS | Pioneer Surgical Technology | 2011-03-07 | 252 | 0 |
| K101525 | PIONEER SPINOUS PROCESS FUSION PLATE | Pioneer Surgical Technology | 2010-10-22 | 142 | 0 |
| K093692 | QUANTUM/ STREAMLINE SPINAL SYSTEM MODEL 02-SERIES AND 10-SER | Pioneer Surgical Technology | 2010-08-11 | 254 | 0 |
| K093771 | QUANTUM/STREAMLINE TL MIS SPINAL SYSTEM | Pioneer Surgical Technology | 2010-08-10 | 245 | 0 |
| K100708 | PIONEER ANTERIOR CERVICAL PLATE MODEL 24-SERIES | Pioneer Surgical Technology | 2010-06-04 | 84 | 0 |
| K100361 | NANOSS BONE VOID FILLER | Pioneer Surgical Technology | 2010-04-22 | 69 | 0 |
| K092295 | PIONEER POSTERIOR CERVICO-THORACIC SYSTEM | Pioneer Surgical Technology | 2010-02-19 | 205 | 0 |
| K091031 | PIONEER SURGICAL NANOSS BVF-E | Pioneer Surgical Technology | 2009-11-17 | 221 | 0 |
| K083449 | E-MATRIX GRAFT BONE EXTENDER | Pioneer Surgical Technology | 2009-06-12 | 203 | 0 |
| K090222 | PIONEER LUMBAR PLATE SYSTEM | Pioneer Surgical Technology | 2009-04-28 | 88 | 0 |
| K083663 | PACP | Pioneer Surgical Technology | 2009-02-25 | 77 | 0 |
| K081558 | PIONEER SURGICAL TECHNOLOGY NANOSS BVF-E, MODELS 5, 10, 20CC | Pioneer Surgical Technology | 2008-08-25 | 83 | 0 |
| K073229 | NERVE MONITORING CABLE | Pioneer Surgical Technology | 2008-06-06 | 204 | 0 |
| K073177 | PIONEER INTERVERTEBRAL FUSION DEVICE SYSTEM | Pioneer Surgical Technology | 2008-05-13 | 182 | 1 |
| K080504 | PIONEER LOWTOP SPINAL ROD SYSTEM | Pioneer Surgical Technology | 2008-03-20 | 24 | 0 |
| K080518 | PIONEER SURGICAL TECHNOLOGY QUANTUM SPINAL SYSTEM | Pioneer Surgical Technology | 2008-03-20 | 24 | 0 |
| K080026 | QUANTUM-MIS CANNULATED SYSTEM | Pioneer Surgical Technology | 2008-01-28 | 24 | 0 |
| K072703 | PIONEER SLIMFUSE ANTERIOR CERVICAL PLATING SYSTEM | Pioneer Surgical Technology | 2008-01-10 | 108 | 0 |
| K072187 | PIONEER LOWTOP SPINAL ROD SYSTEM | Pioneer Surgical Technology | 2007-10-12 | 67 | 0 |
| K070973 | QUANTUM SPINAL SYSTEM | Pioneer Surgical Technology | 2007-07-03 | 88 | 0 |
| K070551 | MODIFICATION TO: PIONEER SURGICAL TECHNOLOGY QUANTUM SPINAL | Pioneer Surgical Technology | 2007-03-29 | 30 | 0 |
| K061151 | PIONEER VERTEBRAL SPACER (VERTEBRAL SPACER) | Pioneer Surgical Technology | 2006-07-24 | 90 | 0 |
| K053053 | PACP SYSTEM | Pioneer Surgical Technology | 2005-11-16 | 16 | 0 |
| K043066 | PIONEER ANTERIOR CERVICAL PLATE SYSTEM | Pioneer Surgical Technology | 2005-02-03 | 87 | 0 |
| K043206 | PIONEER VERTEBRAL BODY REPLACEMENT DEVICE (PIONEER VERTEBRAL | Pioneer Surgical Technology | 2005-01-21 | 63 | 0 |
| K041167 | PIONEER SURGICAL TECHNOLOGY QUANTUM SPINAL SYSTEM | Pioneer Surgical Technology | 2004-07-23 | 80 | 1 |
| K022908 | POSTERIOR CABLE SCREW | Pioneer Surgical Technology | 2004-01-22 | 506 | 0 |
| K022726 | STAYFUSE GT-IP | Pioneer Surgical Technology | 2002-09-06 | 21 | 0 |
| K003496 | CANNULATED SCREW SYSTEM | Pioneer Surgical Technology | 2001-02-08 | 87 | 1 |
| K002110 | SPL CRIMP SYSTEM | Pioneer Surgical Technology | 2000-10-06 | 86 | 0 |
| K001709 | TROCHANTERIC REATTACHMENT DEVICE (STANDARD) AND (LONG), MODE | Pioneer Surgical Technology | 2000-08-31 | 87 | 0 |
| K000734 | PIONEER SURGICAL TECHNOLOGY EXTENDED GTR, MODEL 501-601 | Pioneer Surgical Technology | 2000-05-05 | 59 | 0 |
| K993286 | PIONEER SILICOAT STERNAL CABLE | Pioneer Surgical Technology | 1999-11-23 | 53 | 0 |
| K992616 | SDB CERCLAGE SYSTEM | Pioneer Surgical Technology | 1999-10-27 | 84 | 0 |
| K992617 | HEX BUTTON | Pioneer Surgical Technology | 1999-10-27 | 84 | 0 |
| K990804 | STAYFUSE | Pioneer Surgical Technology | 1999-04-29 | 50 | 2 |
| K990322 | PERRY HUMERAL NAIL | Pioneer Surgical Technology | 1999-04-01 | 58 | 0 |
| K980690 | CABLE SCREW WITH INTEGRAL CRIMP | Pioneer Surgical Technology | 1998-05-22 | 88 | 0 |
| K974016 | CERCLAGE CABLE WITH HEX BUTTON | Pioneer Surgical Technology | 1997-12-19 | 58 | 0 |
| K971728 | PIONEER ELEC-TROCAR DEVICE | Pioneer Surgical Technology | 1997-09-19 | 133 | 0 |
| K972223 | BONE PLATE WITH CABLES | Pioneer Surgical Technology | 1997-09-10 | 89 | 0 |
| K961267 | PIONEER SYSTEM GTR(GREATER TROCHANTEER REATTACHMENT) DEVICE | Pioneer Surgical Technology | 1996-06-27 | 86 | 0 |
| K940729 | PIONEER LABORATORIES BONE PLATE WITH CERCLAGE CABLES | Pioneer Surgical Technology | 1994-12-21 | 306 | 0 |
| K941866 | PIONEER LABORATORIES CABLE SCREW | Pioneer Surgical Technology | 1994-11-28 | 224 | 0 |
| K940690 | PIONEER LABORATORIES BONE SCREW | Pioneer Surgical Technology | 1994-11-22 | 279 | 0 |
| K941174 | PIONEER LABORATORIES CABLE PIN | Pioneer Surgical Technology | 1994-09-19 | 189 | 0 |
| K941213 | SONGER CABLE SYSTEM | Pioneer Surgical Technology | 1994-04-19 | 41 | 0 |
| K935481 | SPONGER CABLE SYSTEM, MODIFICATION | Pioneer Surgical Technology | 1994-01-26 | 125 | 0 |
| K922952 | SONGER CABLE SYSTEM | Pioneer Surgical Technology | 1993-02-23 | 250 | 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