Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Intellijoint Surgical, Inc. · Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
158 daysmedian FDA review time
224 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K211876 | Intellijoint VIEW | Intellijoint Surgical, Inc. | 2021-11-12 | 148 | 0 |
| K191507 | Intellijoint® Navigation System | Intellijoint Surgical, Inc. | 2019-10-01 | 117 | 0 |
| K172849 | Intellijoint HIP System (Cart), Intellijoint HIP System (Por | Intellijoint Surgical, Inc. | 2017-11-16 | 57 | 1 |
| K171525 | Intellijoint HIP Generation 2B System | Intellijoint Surgical, Inc. | 2017-10-30 | 158 | 0 |
| K162364 | Intellijoint HIP Generation 2A System | Intellijoint Surgical, Inc. | 2017-03-02 | 191 | 0 |
| K151364 | Intellijoint HIP(tm) System | Intellijoint Surgical, Inc. | 2015-12-28 | 221 | 0 |
| K133759 | INTELLIJOINT HIP | Intellijoint Surgical, Inc. | 2014-07-23 | 224 | 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