Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Depuy Spine, Inc. — Predicate Candidate Screening
68 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
68 daysmedian FDA review time
189 days90th percentile
68clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K201831 | CONFIDENCE Spinal Cement System | Depuy Spine, Inc. | 2020-08-31 | 60 | 0 |
| K142185 | EXPEDIUM VERSE SPINE SYSTEM | Depuy Spine, Inc. | 2014-11-19 | 103 | 0 |
| K111136 | EXPEDIUM SPINE SYSTEM, VIPER SYSTEM, VIPER 2 SYSTEM | Depuy Spine, Inc. | 2012-06-14 | 419 | 1 |
| K121020 | VIPER SYSTEM | Depuy Spine, Inc. | 2012-05-03 | 29 | 0 |
| K110353 | MOUNTAINEER OCT SPINAL SYSTEM | Depuy Spine, Inc. | 2011-04-07 | 59 | 0 |
| K110216 | EXPEDIUM SYSTEM, VIPER SYSTEM | Depuy Spine, Inc. | 2011-04-01 | 66 | 0 |
| K103133 | VEPER SYSTEM, EXPEDIUM SYSTEM | Depuy Spine, Inc. | 2011-01-18 | 85 | 0 |
| K101993 | VIPER SYSTEM, EXPEDIUM SYSTEM | Depuy Spine, Inc. | 2010-12-07 | 145 | 8 |
| K103100 | MOUNTAINEER OCT SPINAL SYSTEM | Depuy Spine, Inc. | 2010-11-17 | 28 | 0 |
| K101762 | VIPER F2 FACET FIXATION SYSTEM | Depuy Spine, Inc. | 2010-11-15 | 146 | 0 |
| K102701 | VIPER SPINE SYSTEM | Depuy Spine, Inc. | 2010-10-20 | 30 | 0 |
| K101933 | MODIFICATION TO:EXPEDIUM SPINE SYSTEM | Depuy Spine, Inc. | 2010-10-18 | 98 | 0 |
| K093390 | HEALOS DENTAL BONE GRAFT SUBSTITUTE (ALSO CALLED HEALOS OR H | Depuy Spine, Inc. | 2010-05-25 | 208 | 0 |
| K100070 | UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM | Depuy Spine, Inc. | 2010-02-04 | 24 | 0 |
| K091994 | MOUNTAINEER LAMINOPLASTY SYSTEM | Depuy Spine, Inc. | 2010-01-07 | 189 | 0 |
| K092473 | EXPEDIUM SPINE SYSTEM | Depuy Spine, Inc. | 2009-11-25 | 105 | 0 |
| K092626 | MODIFICATION TO: EXPEDIUM SPINE SYSTEM | Depuy Spine, Inc. | 2009-09-25 | 29 | 0 |
| K090648 | VIPER 2 SYSTEM | Depuy Spine, Inc. | 2009-06-10 | 91 | 0 |
| K081917 | DEPUY SPINE BENGAL, CONCORDE, COUGAR, DEVEX AND LEOPARD SYST | Depuy Spine, Inc. | 2009-05-22 | 323 | 0 |
| K090899 | DEPUY SPINE LATERAL SYSTEM | Depuy Spine, Inc. | 2009-05-19 | 48 | 0 |
| K090799 | MODIFICATION TO EXPEDIUM SPINE SYSTEM | Depuy Spine, Inc. | 2009-04-22 | 29 | 0 |
| K090230 | EXPEDIUM SPINE SYSTEM | Depuy Spine, Inc. | 2009-03-06 | 35 | 0 |
| K082942 | MODFICATION TO: EXPEDIUM SPINE SYSTEM | Depuy Spine, Inc. | 2008-10-31 | 29 | 0 |
| K082273 | UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM | Depuy Spine, Inc. | 2008-09-10 | 30 | 0 |
| K081898 | EXPEDIUM SPINE SYSTEM | Depuy Spine, Inc. | 2008-09-10 | 69 | 0 |
| K082195 | MODIFICATIONS TO EXPEDIUM SPINE SYSTEM | Depuy Spine, Inc. | 2008-09-03 | 30 | 0 |
| K081758 | HEALOS FX INJECTABLE BONE GRAFT REPLACEMENT, MODELS 27617500 | Depuy Spine, Inc. | 2008-09-03 | 75 | 0 |
| K081432 | HEALOS II BONE GRAFT SUBSTITUTE | Depuy Spine, Inc. | 2008-08-29 | 100 | 0 |
| K080828 | MOUNTAINEER OCT SPINAL SYSTEM | Depuy Spine, Inc. | 2008-06-27 | 94 | 0 |
| K081252 | EXPEDIUM 4.5MM SPINE SYSTEM | Depuy Spine, Inc. | 2008-05-30 | 28 | 0 |
| K073562 | MODIFICATION TO VIPER SPINE SYSTEM | Depuy Spine, Inc. | 2008-05-15 | 148 | 0 |
| K080313 | MODIFICATION TO EXPEDIUM SPINE SYSTEM | Depuy Spine, Inc. | 2008-05-08 | 92 | 0 |
| K080568 | X-MESH EXPANDABLE CAGE SYSTEM | Depuy Spine, Inc. | 2008-05-01 | 62 | 0 |
| K073364 | EXPEDIUM 4.5MM SPINE SYSTEM | Depuy Spine, Inc. | 2008-04-04 | 126 | 0 |
| K080191 | EAGLE PLUS MICRO ANTERIOR CERVICAL PLATE SYSTEM | Depuy Spine, Inc. | 2008-04-02 | 68 | 0 |
| K073649 | BENGAL STACKABLE CAGE SYSTEM | Depuy Spine, Inc. | 2008-01-25 | 30 | 0 |
| K073126 | EXPEDIUM SPINE SYSTEM | Depuy Spine, Inc. | 2007-12-06 | 30 | 0 |
| K072546 | SWIFT PLUS ANTERIOR CERVICAL PLATE SYSTEM | Depuy Spine, Inc. | 2007-10-05 | 25 | 0 |
| K070387 | EXPEDIUM SPINE SYSTEM | Depuy Spine, Inc. | 2007-09-18 | 221 | 0 |
| K071860 | MODIFICATION TO: VIPER SPINE SYSTEM | Depuy Spine, Inc. | 2007-08-01 | 27 | 0 |
| K063772 | EXPEDIUM SPINE SYSTEM | Depuy Spine, Inc. | 2007-07-10 | 201 | 0 |
| K070994 | EAGLE + ANTERIOR CERVICAL PLATE SYSTEM | Depuy Spine, Inc. | 2007-05-09 | 30 | 0 |
| K070300 | EXPEDIUM SFX CROSS CONNECTOR SYSTEM | Depuy Spine, Inc. | 2007-04-10 | 69 | 1 |
| K063741 | EXPEDIUM SPINE SYSTEM | Depuy Spine, Inc. | 2007-01-17 | 30 | 0 |
| K062814 | PIPELINE II ACCESS SYSTEM | Depuy Spine, Inc. | 2006-12-15 | 86 | 0 |
| K063156 | MODIFICATION TO EXPEDIUM SPINE SYSTEM | Depuy Spine, Inc. | 2006-11-22 | 36 | 0 |
| K062174 | MODIFICATION TO EXPEDIUM SPINE SYSTEM | Depuy Spine, Inc. | 2006-11-02 | 94 | 0 |
| K062495 | HEALOS FX BONE GRAFT SUBSTITUTE AND GRAFT MIXING AND DELIVER | Depuy Spine, Inc. | 2006-10-13 | 49 | 0 |
| K062196 | SFX SNAP-FIT CROSS CONNECTOR | Depuy Spine, Inc. | 2006-09-11 | 41 | 0 |
| K061520 | VIPER SPINE SYSTEM | Depuy Spine, Inc. | 2006-06-23 | 21 | 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