Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Custom Spine, Inc. — Predicate Candidate Screening
12 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
119 daysmedian FDA review time
261 days90th percentile
12clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K143143 | PATHWAY ELIF | Custom Spine, Inc. | 2015-07-22 | 261 | 0 |
| K132596 | PROPOSED OPTIMUS | Custom Spine, Inc. | 2014-04-11 | 235 | 1 |
| K120597 | KOMPREDA | Custom Spine, Inc. | 2013-05-03 | 430 | 0 |
| K111726 | PATHWAY AVID | Custom Spine, Inc. | 2012-02-06 | 231 | 0 |
| K111099 | ISSYS LP SPINAL FIXATION SYSTEM | Custom Spine, Inc. | 2011-05-05 | 15 | 1 |
| K092904 | PATHWAY IVB/VBR | Custom Spine, Inc. | 2009-12-22 | 92 | 0 |
| K091134 | CUSTOM SPINE REGENT ANTERIOR CERVICAL PLATE | Custom Spine, Inc. | 2009-08-17 | 119 | 0 |
| K090566 | PATHWAY AVID | Custom Spine, Inc. | 2009-06-01 | 90 | 0 |
| K080281 | PATHWAY | Custom Spine, Inc. | 2008-05-01 | 87 | 0 |
| K072866 | ISSYS LP SPINAL FIXATION SYSTEM | Custom Spine, Inc. | 2007-12-13 | 69 | 1 |
| K070281 | ISSYS LP SPINAL FIXATION SYSTEM | Custom Spine, Inc. | 2007-06-11 | 133 | 1 |
| K043522 | ISSYS PEDICLE SCREW SYSTEM | Custom Spine, Inc. | 2005-01-14 | 25 | 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