Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Spineart SA — Predicate Candidate Screening
12 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
108 daysmedian FDA review time
194 days90th percentile
12clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261205 | SPINEART Navigation Instrument System | Spineart SA | 2026-07-29 | 107 | 0 |
| K253966 | PERLA® TL Posterior Thoraco-lumbar Fixation System | Spineart SA | 2026-05-01 | 141 | 0 |
| K254158 | SPINEART Navigation Instrument System | Spineart SA | 2026-04-09 | 108 | 0 |
| K242933 | SPINEART Navigation Instrument System | Spineart SA | 2025-06-18 | 266 | 0 |
| K242890 | SPINEART Navigation Instrument System | Spineart SA | 2025-03-07 | 165 | 0 |
| K242589 | Scarlet® AL-T | Spineart SA | 2024-10-23 | 54 | 0 |
| K241644 | SPINEART Navigation Instrument System | Spineart SA | 2024-08-07 | 61 | 0 |
| K241321 | Juliet® Ti LL Lumbar Interbody Device | Spineart SA | 2024-07-18 | 69 | 0 |
| K240699 | SCARLET® AC-Ti | Spineart SA | 2024-05-10 | 57 | 0 |
| K231069 | PERLA® TL Posterior Thoraco-lumbar Fixation System | Spineart SA | 2023-10-25 | 194 | 0 |
| K230583 | Tryptik Ti | Spineart SA | 2023-03-22 | 20 | 0 |
| K183630 | SPINEART Navigation Instrument System | Spineart SA | 2019-06-10 | 166 | 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