Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Biomet Sports Medicine · Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
117 daysmedian FDA review time
434 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K140908 | JUGGERKNOT MINI SOFT ANCHOR | Biomet Sports Medicine | 2014-10-02 | 176 | 0 |
| K122437 | NO-PROFILE SCREWS NO-PROFILE WASHER NO-PROFILE SCREWS WASHER | Biomet Sports Medicine | 2013-10-18 | 434 | 0 |
| K123485 | JUGGERKNOTLESS SOFT ANCHORS, JUGGERKNOTLESS M SOFT ANCHORS, | Biomet Sports Medicine | 2013-03-18 | 125 | 2 |
| K110879 | BIOMET SPORTS MEDICINE JUGGERKNOT (TM) MINI SOFT ANCHOR | Biomet Sports Medicine | 2011-08-19 | 142 | 2 |
| K111564 | MAXFIRE MARXMEN MENISCAL REPAIR DEVICE | Biomet Sports Medicine | 2011-06-16 | 10 | 0 |
| K110039 | BIOMET SPORTS MEDICINE STERNAL CLOSURE SYSTEM | Biomet Sports Medicine | 2011-05-03 | 117 | 0 |
| K103145 | HAMMERLOC TM TIBIAL FIXATION DEVICE | Biomet Sports Medicine | 2011-02-09 | 107 | 0 |
| K101063 | SLEEVE WITH ZIPLOOP FIXATION DEVICES | Biomet Sports Medicine | 2010-06-23 | 68 | 1 |
| K083070 | TOGGLELOC SYSTEM | Biomet Sports Medicine | 2008-12-16 | 62 | 5 |
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