Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ascension Orthopedic · Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
160 daysmedian FDA review time
231 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K140463 | INTEGRA EXTERNAL FIXATION SYSTEM | Ascension Orthopedic | 2014-10-10 | 228 | 0 |
| K131360 | INTEGRA TITANIUM BONE WEDGE | Ascension Orthopedic | 2013-08-07 | 86 | 0 |
| K130050 | TITAN REVERSE SHOULDER SYSTEM | Ascension Orthopedic | 2013-06-18 | 160 | 0 |
| K112438 | TITAN MODULAR TOTAL SHOULDER SYSTEM | Ascension Orthopedic | 2012-04-11 | 231 | 0 |
| K112481 | FIRST CHOICE DRUJ SYSTEM, PARTIAL HEAD IMPLANT | Ascension Orthopedic | 2012-04-09 | 224 | 0 |
| K112278 | ASCENSION NUGRIP CMC IMPLANT | Ascension Orthopedic | 2011-11-04 | 87 | 0 |
| K111799 | NUGAIT(TM) SUBTALAR IMPLANT SYSTEM | Ascension Orthopedic | 2011-08-19 | 53 | 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