Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Synthes Spine — Predicate Candidate Screening
36 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
86 daysmedian FDA review time
230 days90th percentile
36clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K122211 | SYNTHES NAVIGABLE PEDICLE PREPARATION INSTRUMENTS | Synthes Spine | 2012-12-17 | 145 | 0 |
| K120838 | SYNTHES MATRIX SYSTEM | Synthes Spine | 2012-07-31 | 133 | 0 |
| K111048 | SYNTHES SCOUT TACK FIXATION | Synthes Spine | 2012-06-14 | 426 | 0 |
| K120928 | SYNTHES MATRIX SYSTEM | Synthes Spine | 2012-05-18 | 52 | 0 |
| K120571 | SYNTHES USS CONNECTOR | Synthes Spine | 2012-05-14 | 77 | 0 |
| K113149 | SYNTHES USS CONNECTORS | Synthes Spine | 2012-02-01 | 100 | 0 |
| K113044 | SYNTHES MIRS | Synthes Spine | 2011-12-21 | 70 | 3 |
| K111358 | SYNTHES USS | Synthes Spine | 2011-11-18 | 186 | 0 |
| K103558 | SYNTHES SCOUT VESSEL GUARD | Synthes Spine | 2011-02-18 | 78 | 0 |
| K103287 | SYNTHES 6.0 COCR AND CPT TI-3 RODS | Synthes Spine | 2011-01-05 | 65 | 0 |
| K093762 | SYNTHES ZERO-P | Synthes Spine | 2010-12-20 | 378 | 1 |
| K100952 | MODIFICATION TO SYNTHES MATRIX SYSTEM | Synthes Spine | 2010-08-05 | 121 | 2 |
| K100089 | SYNTHES T-PAL SPACER | Synthes Spine | 2010-05-13 | 121 | 1 |
| K091159 | SYNTHES ORACLE PLATE | Synthes Spine | 2009-07-10 | 80 | 0 |
| K090549 | SYNTHES SYNAPSE TRANSCONNECTOR | Synthes Spine | 2009-05-21 | 80 | 0 |
| K082914 | CLAMPFIX | Synthes Spine | 2008-12-11 | 72 | 0 |
| K082572 | USS ILIOSACRAL, USS POLYAXIAL | Synthes Spine | 2008-11-24 | 80 | 0 |
| K072791 | ORACLE SPACER, OPAL SPACER | Synthes Spine | 2007-12-26 | 86 | 0 |
| K071667 | SYNTHES VECTRA-ONE SYSTEM | Synthes Spine | 2007-11-30 | 164 | 3 |
| K051665 | SYNTHES VECTRA-T SYSTEM | Synthes Spine | 2005-09-09 | 79 | 2 |
| K041389 | SYNTHES CONTOURED SYNMESH SPACER | Synthes Spine | 2004-10-01 | 129 | 0 |
| K032534 | SYNTHES AFS | Synthes Spine | 2004-04-01 | 230 | 0 |
| K020244 | SYNTHES THORACOLUMBAR SPINE LOCKING PLATE (TSLP) | Synthes Spine | 2002-04-22 | 88 | 0 |
| K001864 | SYNTHES CERVIFIX SYSTEM | Synthes Spine | 2000-07-20 | 30 | 0 |
| K000742 | SYNTHES ANTERIOR CSLP SYSTEM | Synthes Spine | 2000-03-29 | 22 | 0 |
| K000536 | SYNTHES ANTERIOR CSLP SYSTEM | Synthes Spine | 2000-03-15 | 28 | 1 |
| K000450 | MODIFICATION TO SYNTHES USS | Synthes Spine | 2000-03-10 | 28 | 0 |
| K992739 | CLICK'X | Synthes Spine | 2000-02-08 | 176 | 1 |
| K991089 | SYNTHES CERVIFIX SYSTEM | Synthes Spine | 1999-08-27 | 149 | 0 |
| K990745 | MODIFICATION TO SYNTHES UNIVERSAL SPINAL SYSTEM | Synthes Spine | 1999-03-30 | 22 | 0 |
| K984612 | SYNTHES SPINE POSTERIOR UNIVERSAL SYSTEM | Synthes Spine | 1999-01-19 | 26 | 0 |
| K982987 | SYNTHES POSTERIOR UNIVERSAL SPINAL SYSTEM | Synthes Spine | 1998-10-21 | 56 | 0 |
| K980761 | SYNTHES SPINE PEDIATRIC ROD SYSTEM | Synthes Spine | 1998-08-04 | 158 | 0 |
| K980928 | SYNTHES SPINE UNIVERSAL SPINAL HOOK, ROD, PEDICLE/SACRAL SCR | Synthes Spine | 1998-05-11 | 61 | 0 |
| K974525 | SYNTHES SPINE ANTERIOR THORACOLUMBAR ROD CLAMP (ATRC) SYSTEM | Synthes Spine | 1998-03-02 | 90 | 0 |
| K943725 | UNIVERSAL SPINAL ROD AND SCREW FIXATION SYSTEM | Synthes Spine | 1995-08-25 | 389 | 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