Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Arthrotek, Inc. · Predicate Candidate Screening
17 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
78 daysmedian FDA review time
94 days90th percentile
17clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K061776 | ARTHROTEK MAXFIRE MENISCAL REPAIR DEVICE | Arthrotek, Inc. | 2006-09-25 | 94 | 0 |
| K061801 | 2.8 & 3.5MM LACTOSCREW SUTURE ANCHORS | Arthrotek, Inc. | 2006-08-07 | 42 | 0 |
| K061657 | HITCH LACTOSORB SUTURE ANCHOR | Arthrotek, Inc. | 2006-07-25 | 42 | 0 |
| K061389 | ALLTHREAD LACTOSORB SUTURE ANCHOR | Arthrotek, Inc. | 2006-07-19 | 62 | 0 |
| K060693 | MICROSTRIKE AND ALLTHREAD PEEK SUTURE ANCHOR | Arthrotek, Inc. | 2006-06-06 | 83 | 0 |
| K053461 | EZLOC FEMORAL FIXATION DEVICE | Arthrotek, Inc. | 2006-02-03 | 52 | 0 |
| K051069 | NONRESORBABLE CENTRALOC TIBIAL SCREW & WASHER | Arthrotek, Inc. | 2005-06-29 | 64 | 0 |
| K042460 | TI - SCREW ANCHOR SP | Arthrotek, Inc. | 2004-10-29 | 49 | 0 |
| K041274 | RESORBABLE INTERFERENCE SCREW | Arthrotek, Inc. | 2004-07-28 | 77 | 1 |
| K041261 | FEMORAL HOOK | Arthrotek, Inc. | 2004-06-07 | 27 | 2 |
| K040604 | INNERVUE DIAGNOSTIC SCOPE SYSTEM | Arthrotek, Inc. | 2004-06-04 | 88 | 0 |
| K040500 | ARTHROTEK LACTONAIL | Arthrotek, Inc. | 2004-05-25 | 89 | 0 |
| K033718 | MAXBRAID POLYESTER PLUS AND POLYETHYLENE PLUS SUTURE | Arthrotek, Inc. | 2004-02-12 | 78 | 0 |
| K032072 | LACTOSORB L15 SCREW ANCHOR WITH LACTOCARBONATE SUTURE | Arthrotek, Inc. | 2003-10-01 | 90 | 0 |
| K014305 | RESORBABLE LACTOSORB-L ACL CROSSPIN | Arthrotek, Inc. | 2002-03-29 | 88 | 0 |
| K012872 | RESORBABLE SCREW ANCHOR | Arthrotek, Inc. | 2001-11-20 | 85 | 0 |
| K862286 | ARTHROPHONOMETER | Arthrotek, Inc. | 1987-01-07 | 205 | 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