Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Zimmer Biomet Spine, Inc. — Predicate Candidate Screening
15 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
74 daysmedian FDA review time
264 days90th percentile
15clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K212023 | Virage Navigation System | Zimmer Biomet Spine, Inc. | 2021-08-27 | 59 | 0 |
| K203218 | CaP Spheres Pellet Pack | Zimmer Biomet Spine, Inc. | 2021-05-04 | 183 | 0 |
| K210275 | Polaris Spinal System | Zimmer Biomet Spine, Inc. | 2021-04-02 | 60 | 0 |
| K203507 | Vitality® Spinal Fixation System | Zimmer Biomet Spine, Inc. | 2021-01-28 | 59 | 0 |
| K202309 | Epic Anterior Thoracolumbar Plate System, Gallery Laminoplas | Zimmer Biomet Spine, Inc. | 2020-10-08 | 55 | 0 |
| K191722 | Vital Navigation System | Zimmer Biomet Spine, Inc. | 2019-12-02 | 158 | 0 |
| K192133 | Zimmer Biomet Universal Navigation System | Zimmer Biomet Spine, Inc. | 2019-10-29 | 83 | 0 |
| K190556 | Zimmer Biomet Universal Navigation System | Zimmer Biomet Spine, Inc. | 2019-10-24 | 233 | 0 |
| K183550 | Vitality® Spinal Fixation System | Zimmer Biomet Spine, Inc. | 2019-04-08 | 109 | 0 |
| K181096 | Avenue P Cage System | Zimmer Biomet Spine, Inc. | 2019-01-15 | 264 | 0 |
| K180227 | Polaris Spinal Growth System | Zimmer Biomet Spine, Inc. | 2018-03-15 | 48 | 0 |
| K171495 | Zyston Strut Open Titanium Spacer System | Zimmer Biomet Spine, Inc. | 2018-02-12 | 266 | 0 |
| K172275 | Vitality® Spinal Fixation System, Vitality®+ Power Instrumen | Zimmer Biomet Spine, Inc. | 2017-09-27 | 61 | 0 |
| K171907 | Vitality® Spinal Fixation System | Zimmer Biomet Spine, Inc. | 2017-07-14 | 18 | 2 |
| K163543 | Biomet Fusion System | Zimmer Biomet Spine, Inc. | 2017-02-28 | 74 | 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