Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Surgtech, Inc. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
225 daysmedian FDA review time
282 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K191192 | SurgTech GENOLL Total Knee System | Surgtech, Inc. | 2019-08-01 | 90 | 0 |
| K173455 | SurgTech Bipolar Head System | Surgtech, Inc. | 2018-06-14 | 219 | 0 |
| K162125 | MALUC™ Total Hip Arthroplasty System | Surgtech, Inc. | 2017-05-10 | 282 | 0 |
| K163363 | SurgTech Thoracolumbosacral (TLS) Posterior Fixation System | Surgtech, Inc. | 2017-04-05 | 126 | 0 |
| K161894 | SurgTech Trauma System | Surgtech, Inc. | 2017-02-21 | 225 | 0 |
| K152200 | SurgTech Interbody System | Surgtech, Inc. | 2016-03-25 | 232 | 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