Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Innovative Surgical Designs, Inc. · Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
61 daysmedian FDA review time
226 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K220297 | True Tulip, True M.I.S. | Innovative Surgical Designs, Inc. | 2022-09-16 | 226 | 0 |
| K212627 | True Tulip, True M.I.S. | Innovative Surgical Designs, Inc. | 2022-02-18 | 183 | 0 |
| K210816 | True Tulip, True M.I.S. | Innovative Surgical Designs, Inc. | 2021-05-18 | 61 | 0 |
| K201780 | True Tulip System, True M.I.S. System | Innovative Surgical Designs, Inc. | 2020-07-22 | 22 | 0 |
| K181584 | Redi-Spine | Innovative Surgical Designs, Inc. | 2018-08-10 | 56 | 0 |
| K171559 | True Spinal Fixation System | Innovative Surgical Designs, Inc. | 2017-07-24 | 55 | 0 |
| K170710 | True Spinal Fixation System | Innovative Surgical Designs, Inc. | 2017-07-14 | 128 | 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