Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Zimmer Spine — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
133 daysmedian FDA review time
185 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K123552 | INSTINCT JAVA SYSTEM | Zimmer Spine | 2013-04-19 | 151 | 0 |
| K122592 | INSTINCT JAVA SYSTEM | Zimmer Spine | 2013-01-04 | 133 | 0 |
| K113270 | INSTINCT JAVA SYSTEM | Zimmer Spine | 2011-12-16 | 42 | 0 |
| K111301 | INSTINCT JAVA SYSTEM | Zimmer Spine | 2011-08-26 | 109 | 0 |
| K110348 | UNIVERSAL CLAMP SPINAL FIXATION SYSTEM | Zimmer Spine | 2011-08-11 | 185 | 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