Depuy Spine, Inc.: FDA filings under this applicant name
FDA lists 71 510(k) clearances under the applicant name “Depuy Spine, Inc.” (first 2004, latest 2022), plus 2 PMA decisions, across 16 product codes in 3 review panels. Median 510(k) review time under this name: 69 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Johnson & Johnson MedTech, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 2 | 224 |
| 2013 | 0 | — |
| 2014 | 1 | 103 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 1 | 60 |
| 2021 | 0 | — |
| 2022 | 1 | 78 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Depuy Spine, Inc. took a median 69 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 90 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NKB | Thoracolumbosacral Pedicle Screw System | 30 | 30 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 10 | 10 |
| KWP | Appliance, Fixation, Spinal Interlaminal | 5 | 5 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 5 | 4 |
| MQP | Spinal Vertebral Body Replacement Device | 4 | 4 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | 3 | 3 |
| MNI | Orthosis, Spinal Pedicle Fixation | 3 | 3 |
| MQV | Filler, Bone Void, Calcium Compound | 3 | 3 |
| LYC | Bone Grafting Material, Synthetic | 2 | 2 |
| NDN | Cement, Bone, Vertebroplasty | 2 | 2 |
Plus 6 more product codes.
Review panels
- Orthopedic (70)
- Dental (2)
- Neurology (1)
Most recent Depuy Spine, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K222276 | CONDUIT Cages; FIBERGRAFT BG Putty | ODP | 2022-10-15 | 78 |
| K201831 | CONFIDENCE Spinal Cement System | NDN | 2020-08-31 | 60 |
| K142185 | EXPEDIUM VERSE SPINE SYSTEM | NKB | 2014-11-19 | 103 |
| K111136 | EXPEDIUM SPINE SYSTEM, VIPER SYSTEM, VIPER 2 SYSTEM | NKB | 2012-06-14 | 419 |
| K121020 | VIPER SYSTEM | NKB | 2012-05-03 | 29 |
| K110353 | MOUNTAINEER OCT SPINAL SYSTEM | KWP | 2011-04-07 | 59 |
| K110216 | EXPEDIUM SYSTEM, VIPER SYSTEM | NKB | 2011-04-01 | 66 |
| K103133 | VEPER SYSTEM, EXPEDIUM SYSTEM | NKB | 2011-01-18 | 85 |
| K101993 | VIPER SYSTEM, EXPEDIUM SYSTEM | NKB | 2010-12-07 | 145 |
| K101923 | CONCORDE CURVE SYSTEM | MAX | 2010-12-01 | 145 |
61 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P040006 | PMA | CHARITE ARTIFICIAL DISC | 2004-10-26 |
| P960025 | PMA | BRANTIGEN I/F CAGE(R) USED WITH VSP(R) SPINE PLATES AND PEDICLE SCREWS | 1999-02-02 |
Recalls
57 product recalls in 15 recall events; 2 initiated in the last five years. Most recent: 2022-05-20.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Depuy Spine, Inc. is the lead sponsor of 5 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT00432159: Comparison of DISCOVER™ Artificial Cervical Disc and ACDF for Treatment of Cervical DDD (IDE Study) (Completed, started 2006-07-01)
- NCT00215332: CHARITE™ vs. ALIF 5-Year Follow-up (Completed, started 2005-03)
- NCT00215319: Titanium Surgical Mesh and MOSS-Miami Screws for Lumbar Fusion. (Completed, started 2000-12)
- NCT00215293: Cervical I/F Cage for Anterior Cervical Fusion (Completed, started 2000-08)
- NCT00215306: CHARITÉ™ Artificial Disc Compared to Anterior Interbody Fusion for Treatment of Degenerative Disc Disease (Completed, started 2000-03)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Depuy, Inc. (303 510(k)s)
- DePuy Orthopaedics, Inc. (210 510(k)s)
- Depuy Mitek, A Johnson & Johnson Company (58 510(k)s)
- Depuy Ireland UC (50 510(k)s)
- DePuy Synthes (20 510(k)s)
- Depuy Mitek (15 510(k)s)
- Depuy Ace Medical Co. (10 510(k)s)
- Depuy Motech Acromed (4 510(k)s)
- Depuy Spine, A Johnson & Johnson Company (4 510(k)s)
- Depuy Mitek, A Johnson and Johnson Company (3 510(k)s)
- Depuy Mitek, Inc., A Johnson and Johnson Company (3 510(k)s)
- Depuy Synthes Spine (3 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Depuy Spine, Inc.?
FDA lists 71 510(k) clearances under the applicant name “Depuy Spine, Inc.” (first 2004, latest 2022), plus 2 PMA decisions, across 16 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Depuy Spine, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Depuy Spine, Inc. is 69 days.
Which FDA product codes appear under Depuy Spine, Inc.?
The most frequent FDA product codes under this applicant name are NKB (Thoracolumbosacral Pedicle Screw System, 30); KWQ (Appliance, Fixation, Spinal Intervertebral Body, 10); KWP (Appliance, Fixation, Spinal Interlaminal, 5).
Next steps
- See all 71 Depuy Spine, Inc. clearances with predicates and recalls
- Run predicate analysis for product code NKB, Depuy Spine, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.