Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
X-Spine Systems, Inc. — Predicate Candidate Screening
34 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
103 daysmedian FDA review time
218 days90th percentile
34clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K173832 | InTice™-C Porous Ti Cervical Interbody System | X-Spine Systems, Inc. | 2018-05-17 | 150 | 0 |
| K180153 | X-spine Cortical Bone Screw System | X-Spine Systems, Inc. | 2018-03-15 | 55 | 0 |
| K170119 | Calix Lumbar Spinal Implant System | X-Spine Systems, Inc. | 2017-09-29 | 259 | 0 |
| K171567 | IRIX-A Lumbar Integrated Fusion System | X-Spine Systems, Inc. | 2017-08-28 | 90 | 1 |
| K171075 | Calix-C Cervical Interbody Spacer | X-Spine Systems, Inc. | 2017-08-01 | 112 | 0 |
| K170224 | Spider Cervical Plating System | X-Spine Systems, Inc. | 2017-07-06 | 162 | 0 |
| K170530 | Butrex Lumbar Buttress Plating System | X-Spine Systems, Inc. | 2017-03-22 | 28 | 0 |
| K160959 | Xsert Lumbar Expandable Interbody System | X-Spine Systems, Inc. | 2016-11-17 | 226 | 0 |
| K162944 | Irix-C Cervical Integrated Fusion System | X-Spine Systems, Inc. | 2016-11-07 | 17 | 0 |
| K160428 | Certex Spinal Fixation System | X-Spine Systems, Inc. | 2016-05-05 | 79 | 0 |
| K160114 | Xspan Laminoplasty Fixation System | X-Spine Systems, Inc. | 2016-03-15 | 56 | 0 |
| K152132 | X-spine Pedicle Screw System | X-Spine Systems, Inc. | 2015-09-25 | 56 | 1 |
| K150834 | Atrax Anterior Cervical Plating System | X-Spine Systems, Inc. | 2015-07-10 | 102 | 0 |
| K133947 | IRIX-A LUMBAR INTEGRATED FUSION SYSTEM | X-Spine Systems, Inc. | 2014-07-29 | 218 | 0 |
| K140079 | SILEX SACROILIAC JOINT FUSION SYSTEM | X-Spine Systems, Inc. | 2014-03-25 | 71 | 0 |
| K133094 | CERTEX OCT SPINAL IMPLANT SYSTEM | X-Spine Systems, Inc. | 2013-12-11 | 72 | 0 |
| K131350 | CALIX LUMBAR SPINAL IMPLANT SYSTEM | X-Spine Systems, Inc. | 2013-10-23 | 166 | 0 |
| K131951 | IRIX-C CERVICAL INTEGRATED FUSION SYSTEM | X-Spine Systems, Inc. | 2013-08-14 | 48 | 0 |
| K130438 | AXLE INTERSPINOUS FUSION SYSTEM | X-Spine Systems, Inc. | 2013-06-27 | 126 | 0 |
| K123932 | ZYGAFIX SPINAL FACET SCREW SYSTEM | X-Spine Systems, Inc. | 2013-05-01 | 132 | 0 |
| K123702 | SILEX SACROILIAC JOINT FUSION SYSTEM | X-Spine Systems, Inc. | 2013-03-11 | 98 | 0 |
| K122163 | CERTEX SPINAL IMPLANT SYSTEM | X-Spine Systems, Inc. | 2012-10-31 | 103 | 0 |
| K120832 | FORTEX PEDICLE SCREW SYSTEM | X-Spine Systems, Inc. | 2012-10-23 | 218 | 3 |
| K112592 | AXLE PEEK INTERSPINOUS FUSION SYSTEM | X-Spine Systems, Inc. | 2011-12-05 | 89 | 0 |
| K112036 | CALIX PC SPINAL IMPLANT SYSTEM | X-Spine Systems, Inc. | 2011-11-08 | 113 | 0 |
| K101471 | AXLE INTERSPINOUS FUSION SYSTEM | X-Spine Systems, Inc. | 2010-11-24 | 181 | 1 |
| K100154 | FIXCET SPINAL FACET SCREW SYSTEM | X-Spine Systems, Inc. | 2010-05-21 | 121 | 0 |
| K092360 | ACP4 SPINAL IMPLANT SYSTEM | X-Spine Systems, Inc. | 2010-01-22 | 171 | 0 |
| K090224 | FORTEX PEDICLE SCREW SYSTEM | X-Spine Systems, Inc. | 2009-07-30 | 181 | 0 |
| K083637 | CALIX SPINAL IMPLANT SYSTEM | X-Spine Systems, Inc. | 2009-04-20 | 132 | 0 |
| K072943 | BUTREX BUTTRESS PLATING SYSTEM | X-Spine Systems, Inc. | 2008-01-28 | 103 | 0 |
| K072282 | CAPLESS LI PEDICLE SCREW SYSTEM | X-Spine Systems, Inc. | 2007-09-14 | 29 | 1 |
| K052847 | CAPLESS PEDICLE SCREW SYSTEM | X-Spine Systems, Inc. | 2005-12-12 | 66 | 0 |
| K052292 | SPIDER CERVICAL PLATING (SCP) SYSTEM | X-Spine Systems, Inc. | 2005-10-21 | 59 | 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