Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Biomet Spine — Predicate Candidate Screening
19 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
91 daysmedian FDA review time
228 days90th percentile
19clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K152622 | Alta ACDF System | Biomet Spine | 2016-07-08 | 298 | 0 |
| K151974 | Polaris Spinal System | Biomet Spine | 2015-11-13 | 120 | 0 |
| K151064 | Solitaire-C Cervical Spacer System, C-Thru Anterior Spinal S | Biomet Spine | 2015-08-12 | 114 | 0 |
| K151224 | Lineum OCT Spine System | Biomet Spine | 2015-06-30 | 54 | 0 |
| K141791 | BIOMET FUSION SYSTEM | Biomet Spine | 2014-10-09 | 99 | 0 |
| K121130 | POLARIS SPINAL SYSTEM-BALLISTA SPINAL RODS | Biomet Spine | 2012-06-15 | 63 | 0 |
| K112014 | ZYSTON STRAIGHT SPACER SYSTEM | Biomet Spine | 2011-10-17 | 95 | 0 |
| K103393 | POLARIS SPINAL SYSTEM | Biomet Spine | 2011-02-02 | 75 | 0 |
| K093629 | SOLITAIRE AND SOLITAIRE PEEK ANTERIOR SPINAL SYSTEM | Biomet Spine | 2010-03-09 | 106 | 1 |
| K091067 | 5.5 POLARIS SPINAL SYSTEM | Biomet Spine | 2009-07-14 | 91 | 0 |
| K082793 | INTERGRO DBM | Biomet Spine | 2009-04-02 | 191 | 0 |
| K081952 | SYNERGY SPINAL SYSTEM (6.35 POLARIS) | Biomet Spine | 2008-10-07 | 90 | 0 |
| K081636 | PEEK-OPTIMA ALIF SPACER | Biomet Spine | 2008-08-07 | 57 | 0 |
| K081501 | SOLITAIRE ANTERIOR SPINAL SYSTEM | Biomet Spine | 2008-07-02 | 34 | 0 |
| K081395 | SOLITAIRE PEEK-OPTIMA ANTERIOR SPINAL SYSTEM | Biomet Spine | 2008-06-25 | 37 | 0 |
| K080646 | C-TEK MAXAN ANTERIOR CERVICAL PLATE SYSTEM | Biomet Spine | 2008-05-02 | 57 | 2 |
| K071377 | POLARIS BE RODS | Biomet Spine | 2007-08-06 | 81 | 0 |
| K063393 | SMALL STATURE SPACERS | Biomet Spine | 2007-06-25 | 228 | 0 |
| K063139 | SPINAL STABILIZING SPHERE SYSTEM | Biomet Spine | 2007-04-04 | 170 | 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