Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Depuy Mitek, A Johnson & Johnson Company · Predicate Candidate Screening
58 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
73 daysmedian FDA review time
147 days90th percentile
58clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K143660 | Milagro / Milagro Advance Interference Screw | Depuy Mitek, A Johnson & Johnson Company | 2015-05-21 | 149 | 0 |
| K142574 | 4.5mm Healix Ti Anchor, with 2 or 3 strands of #2 Permacord | Depuy Mitek, A Johnson & Johnson Company | 2014-10-24 | 42 | 0 |
| K140896 | VAPR ARCTIC SUCTION ELECTRODE | Depuy Mitek, A Johnson & Johnson Company | 2014-08-05 | 119 | 0 |
| K141259 | GRYPHON BR ANCHOR WITH PERMACORD, GRYPHON BR DS ANCHOR WITH | Depuy Mitek, A Johnson & Johnson Company | 2014-06-10 | 26 | 0 |
| K133794 | 4.5MM HEALIX ADVANCE BR ANCHOR, WITH 2 OR 3 STRANDS OF #2 PE | Depuy Mitek, A Johnson & Johnson Company | 2014-02-04 | 53 | 0 |
| K132241 | GRYPHON BR ANCHOR W/ PROKNOT TECHNOLOGY, GRYPHON BR ANCHOR W | Depuy Mitek, A Johnson & Johnson Company | 2013-11-05 | 110 | 0 |
| K130814 | RIGIDLOOP FIXATION DEVICE (15MM, 60MM, XL, 20MM, 25MM, 30MM, | Depuy Mitek, A Johnson & Johnson Company | 2013-08-01 | 129 | 0 |
| K131974 | HEALIX ADVANCE KNOTLESS BR ANCHOR (6.5MM) | Depuy Mitek, A Johnson & Johnson Company | 2013-07-25 | 27 | 0 |
| K131191 | 4MM & 5MM FULL RADIUS BLADE PLUS, 4MM & 5MM BARREL BUR PLUS/ | Depuy Mitek, A Johnson & Johnson Company | 2013-07-22 | 87 | 0 |
| K130912 | OMNICUT RESECTION BLADE | Depuy Mitek, A Johnson & Johnson Company | 2013-06-14 | 73 | 0 |
| K130917 | HEALIX ADVANCE KNOTLESS BR ANCHOR | Depuy Mitek, A Johnson & Johnson Company | 2013-05-24 | 51 | 0 |
| K130539 | HEALIX ADVANCE KNOTLESS PEEK ANCHOR (4.75MM)(5.5MM) | Depuy Mitek, A Johnson & Johnson Company | 2013-05-21 | 81 | 0 |
| K130105 | RIGIDFIX CURVE ST ACL PLA CROSS PIN SYSTEM, RIGIDFIX CURVE S | Depuy Mitek, A Johnson & Johnson Company | 2013-05-17 | 122 | 0 |
| K130169 | FMS VUE FLUID MANAGMENT SYSTEM, FMS CONNECT INTERFACE CABLE | Depuy Mitek, A Johnson & Johnson Company | 2013-05-01 | 97 | 0 |
| K123362 | MILAGRO ADVANCE INTERFERENCE SCREW | Depuy Mitek, A Johnson & Johnson Company | 2013-02-01 | 92 | 0 |
| K122869 | MILAGRO INTERFERENCE SCREWS | Depuy Mitek, A Johnson & Johnson Company | 2012-12-13 | 85 | 0 |
| K122425 | VAPR P50 SUCTION ELECTRODE VAPR S90 SUCTION ELECTRODE VAPR P | Depuy Mitek, A Johnson & Johnson Company | 2012-11-05 | 88 | 0 |
| K120589 | MILAGRO INTERFERENCE SCREWS | Depuy Mitek, A Johnson & Johnson Company | 2012-04-24 | 56 | 0 |
| K120095 | SIDE EFFECT WITH HAND CONTROLS, HOOK ELECTRODE WITH HAND CON | Depuy Mitek, A Johnson & Johnson Company | 2012-04-06 | 85 | 0 |
| K113545 | VAPR VUE GENERATOR, VAPR 3 ELECTROSURGICAL SYSTEM, VAPR II E | Depuy Mitek, A Johnson & Johnson Company | 2012-02-27 | 88 | 0 |
| K112417 | VARIOUS | Depuy Mitek, A Johnson & Johnson Company | 2012-01-13 | 143 | 0 |
| K113534 | HEALIX KNOTLESS ANCHOR | Depuy Mitek, A Johnson & Johnson Company | 2011-12-20 | 20 | 0 |
| K112249 | HEALIX KNOTLESS(TM) ANCHOR | Depuy Mitek, A Johnson & Johnson Company | 2011-10-25 | 81 | 0 |
| K111631 | GIL ANCHOR / GIL QUICK ANCHOR PLUS, HEALIX TI DUAL THREADED | Depuy Mitek, A Johnson & Johnson Company | 2011-07-22 | 39 | 0 |
| K103831 | DEPUY MITEK MILAGRO INTERFERENCE SCREW MODEL 231803, 231804, | Depuy Mitek, A Johnson & Johnson Company | 2011-07-21 | 203 | 0 |
| K103712 | GRYPHON PEEK DS ANCHOR W/ ORTHOCORD, GRYPHON PEEK ANCHOR W/ | Depuy Mitek, A Johnson & Johnson Company | 2011-03-11 | 81 | 0 |
| K102298 | TRANSTEND BR ANCHOR W/ ORTHOCORD, TRANSTEND TI ANCHOR W/ORTH | Depuy Mitek, A Johnson & Johnson Company | 2011-01-07 | 147 | 0 |
| K102443 | INTRAFIX TIBIAL SHEATH | Depuy Mitek, A Johnson & Johnson Company | 2010-10-20 | 55 | 0 |
| K100638 | VAPR VUE RADIOFREQUENCY SYSTEM ,MODEL 225024, VPR VUE WIRELE | Depuy Mitek, A Johnson & Johnson Company | 2010-06-18 | 105 | 0 |
| K100012 | GRYPHON T BR DS ANCHOR W/ORTHOCORD, GRYPHON T BR ANCHOR W /O | Depuy Mitek, A Johnson & Johnson Company | 2010-04-30 | 116 | 0 |
| K100532 | VERSALOK PEEK ANCHOR WITH ORTHOCORD SUTURE, MODELS 210818, 2 | Depuy Mitek, A Johnson & Johnson Company | 2010-03-17 | 20 | 0 |
| K092836 | OMNISPAN MENISCAL REPAIR SYSTEM/0 DEGREE, MODEL 228140, RAPI | Depuy Mitek, A Johnson & Johnson Company | 2010-02-04 | 142 | 0 |
| K091041 | RIGIDFIX BIOCRYL 2.7MM BTB (210815), FEMORAL 3.3MM ST (21081 | Depuy Mitek, A Johnson & Johnson Company | 2009-08-07 | 116 | 0 |
| K090669 | RIGIDFIX BIOCRYL CROSS PIN KITS | Depuy Mitek, A Johnson & Johnson Company | 2009-04-03 | 21 | 0 |
| K090124 | GRYPHON P BR DS ANCHOR W/ORTHOCORD,GRYPHON P BR ANCHOR W/ORT | Depuy Mitek, A Johnson & Johnson Company | 2009-03-11 | 49 | 2 |
| K082643 | 3.5 MM SIDE EFFECT ELECTRODE WITH INTEGRATED HANDPIECE, MODE | Depuy Mitek, A Johnson & Johnson Company | 2008-12-19 | 99 | 2 |
| K073281 | CAIS STAPLE | Depuy Mitek, A Johnson & Johnson Company | 2008-05-02 | 163 | 0 |
| K080352 | MICRO QA+ ANCHOR WITHT #3-0 ORTHOCORD SUTURE, MODEL 212843, | Depuy Mitek, A Johnson & Johnson Company | 2008-03-12 | 30 | 0 |
| K073412 | GRYPHON BR AND HEALIX BR ANCHORS | Depuy Mitek, A Johnson & Johnson Company | 2008-01-17 | 44 | 1 |
| K071481 | HEALIX ANCHOR | Depuy Mitek, A Johnson & Johnson Company | 2007-08-09 | 72 | 0 |
| K071257 | MINI QUICKANCHOR AND QUICKANCHOR PLUS WITH ORTHOCORD | Depuy Mitek, A Johnson & Johnson Company | 2007-06-29 | 56 | 0 |
| K070925 | MODIFICATION TO: BIOKNOTLESS BR ANCHOR / LUPINE BR ANCHOR | Depuy Mitek, A Johnson & Johnson Company | 2007-05-02 | 29 | 11 |
| K063478 | VERSALOK ANCHOR WITH FREE STRANDS OF ORTHOCORD SUTURE (21080 | Depuy Mitek, A Johnson & Johnson Company | 2006-12-15 | 28 | 0 |
| K062170 | BIOKNOTLESS AND LUPINE PLUS ANCHORS | Depuy Mitek, A Johnson & Johnson Company | 2006-08-22 | 22 | 7 |
| K060830 | MILAGRO INTERFERENCE SCREW | Depuy Mitek, A Johnson & Johnson Company | 2006-06-15 | 80 | 0 |
| K060271 | SPIRALOK ANCHOR | Depuy Mitek, A Johnson & Johnson Company | 2006-05-04 | 92 | 16 |
| K060553 | RC LOOP /DUAL ORTHOCORD SUTURE,RC LOOP W/ETHIBOND SUTURE,RC | Depuy Mitek, A Johnson & Johnson Company | 2006-05-04 | 64 | 0 |
| K052631 | SUPER QUICKANCHOR PLUS (WITH ORTHOCORD SUTURE) | Depuy Mitek, A Johnson & Johnson Company | 2005-10-21 | 25 | 0 |
| K052630 | ROTATOR CUFF QUICKANCHOR PLUS (WITH ORTHOCORD SUTURE) | Depuy Mitek, A Johnson & Johnson Company | 2005-10-17 | 21 | 0 |
| K051989 | GII QUICKANCHOR PLUS WITH ORTHOCORD SUTURE | Depuy Mitek, A Johnson & Johnson Company | 2005-08-05 | 14 | 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