Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Nextremity Solutions, Inc. — Predicate Candidate Screening
17 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
94 daysmedian FDA review time
154 days90th percentile
17clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K221610 | Nextra CH Cannulated Hammertoe System | Nextremity Solutions, Inc. | 2022-11-04 | 154 | 0 |
| K212979 | CalcShift™ Displacement Calcaneal Osteotomy System | Nextremity Solutions, Inc. | 2022-05-20 | 245 | 0 |
| K220181 | StealthFix Intraosseous Fixation System | Nextremity Solutions, Inc. | 2022-03-22 | 60 | 0 |
| K213301 | InCore Subtalar System | Nextremity Solutions, Inc. | 2021-12-21 | 81 | 0 |
| K213530 | Nextra CH Cannulated Hammertoe System | Nextremity Solutions, Inc. | 2021-12-09 | 34 | 0 |
| K212640 | Stratum® Ankle Fusion Plating System | Nextremity Solutions, Inc. | 2021-11-18 | 90 | 0 |
| K211996 | Nexta PEEK Hammertoe Correction System | Nextremity Solutions, Inc. | 2021-09-23 | 87 | 0 |
| K200785 | Stratum™ Reduced Size Foot Plating System | Nextremity Solutions, Inc. | 2020-07-27 | 123 | 0 |
| K200840 | DuoHex CH Cannulated Hammertoe System | Nextremity Solutions, Inc. | 2020-06-26 | 87 | 0 |
| K200124 | InCore MPJ System | Nextremity Solutions, Inc. | 2020-05-13 | 113 | 0 |
| K192578 | InCore TMT System | Nextremity Solutions, Inc. | 2019-12-31 | 103 | 0 |
| K190231 | InCore® Lapidus Sterile Kits | Nextremity Solutions, Inc. | 2019-05-24 | 107 | 0 |
| K182201 | Stratum™ Foot Plating System | Nextremity Solutions, Inc. | 2018-11-16 | 94 | 0 |
| K180257 | InCore® Lapidus System | Nextremity Solutions, Inc. | 2018-04-25 | 85 | 0 |
| K152548 | AXI+LINE Proximal Bunion Correction System | Nextremity Solutions, Inc. | 2015-12-21 | 104 | 0 |
| K151160 | Arcus Staple System | Nextremity Solutions, Inc. | 2015-09-04 | 126 | 0 |
| K140724 | MSP METATARSAL SHORTENING SYSTEM | Nextremity Solutions, Inc. | 2014-05-14 | 54 | 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