Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Solana Surgical, LLC — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
100 daysmedian FDA review time
191 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K132594 | CROSSCHECK PLATING SYSTEM | Solana Surgical, LLC | 2013-12-13 | 116 | 21 |
| K131187 | LESSER METATARSAL HEAD IMPLANT SYSTEM | Solana Surgical, LLC | 2013-10-22 | 179 | 0 |
| K124045 | FUSEFORCE IMPLANT SYSTEM | Solana Surgical, LLC | 2013-07-10 | 191 | 0 |
| K122738 | GAITWAY IMPLANT SYSTEM, SURGICAL INSTRUMENT SET | Solana Surgical, LLC | 2012-11-07 | 62 | 0 |
| K120390 | SOLAFIX TWIST SCREW IMPLANT SYSTEM, SURGICAL INSTRUMENT SET | Solana Surgical, LLC | 2012-04-10 | 63 | 0 |
| K113752 | METATARSAL DECOMPRESSION IMPLANT SURGICAL INSTRUMENT SET | Solana Surgical, LLC | 2012-02-06 | 47 | 0 |
| K120029 | HEMI PHALANGEAL IMPLANT SURGICAL INSTRUMENT SET | Solana Surgical, LLC | 2012-02-06 | 33 | 0 |
| K090127 | METATARSAL DECOMPRESSION IMPLANT, MODEL 100 | Solana Surgical, LLC | 2009-05-01 | 100 | 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