Synthes: FDA filings under this applicant name
FDA lists 26 510(k) clearances under the applicant name “Synthes” (first 1998, latest 2026), across 14 product codes in 5 review panels. Median 510(k) review time under this name: 146 days. Since 2017 the median was 146 days, against 99 days for all cleared 510(k)s in the same product codes. 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 | 4 | 89 |
| 2013 | 4 | 212 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 2 | 184 |
| 2025 | 2 | 308 |
| 2026 | 3 | 75 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Synthes took a median 146 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 99 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HRS | Plate, Fixation, Bone | 9 | 9 |
| JEY | Plate, Bone | 4 | 4 |
| GXQ | Dura Substitute | 2 | 2 |
| GWO | Plate, Cranioplasty, Preformed, Alterable | 1 | 1 |
| GXN | Plate, Cranioplasty, Preformed, Non-Alterable | 1 | 1 |
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | 1 | 1 |
| KKY | Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction | 1 | 1 |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | 1 | 1 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 1 | 1 |
| MNI | Orthosis, Spinal Pedicle Fixation | 1 | 1 |
Plus 4 more product codes.
Review panels
- Orthopedic (15)
- Dental (5)
- Neurology (4)
- General Hospital (1)
- General and Plastic Surgery (1)
Most recent Synthes 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K254093 | DePuy Synthes VOLT Medial Distal Femur 3.5 Plating System | HRS | 2026-03-10 | 81 |
| K260069 | DePuy Synthes VOLT Proximal Tibia 3.5 Plating System | HRS | 2026-03-09 | 59 |
| K254054 | VOLT Ankle Trauma 2.7/3.5 Plating System; VOLT Calcaneus 2.7 Plating System | HRS | 2026-03-02 | 75 |
| K243715 | Synthes Patient Specific Implants | GXN | 2025-11-12 | 345 |
| K241927 | Synthes Graphic Case & Tray System | KCT | 2025-03-28 | 270 |
| K233994 | VOLT Proximal Humerus 3.5 Plating System | HRS | 2024-07-26 | 221 |
| K233967 | DePuy Synthes MatrixSTERNUM Fixation System | HRS | 2024-05-09 | 146 |
| K131792 | SYNTHECEL DURA REPAIR, SYNTHECEL DURA ONLAY | GXQ | 2013-12-16 | 181 |
| K123723 | SYNTHES MATRIXNEURO CRANIAL PLATING SYSTEM | GWO | 2013-09-05 | 275 |
| K122455 | SYNTHES SMALL EXTERNAL FIXATION SYSTEM, SYNTHES LARGE EXTERNAL FIXATION SYSTEM | KTT | 2013-04-11 | 241 |
16 earlier clearances. See the full list in Caduvo.
Recalls
44 product recalls in 40 recall events; 0 initiated in the last five years. Most recent: 2020-06-18.
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 Synthes is the lead sponsor of 6 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT03635320: The CHINA TFNA Study (Completed, started 2018-12-13)
- NCT02203448: Facet Wedge Post Market Study (Completed, started 2014-05-01)
- NCT01282294: Clinical Follow-up to Evaluate the Clinical Usefulness of Gentamicin-coated Titanium Nails in Tibia Fractures (Completed, started 2011-02)
- NCT02056834: chronOS Inject in Proximal Tibial Fractures (Completed, started 2010-03-01)
- NCT01847898: Study on the Treatment of Osteoporotic Vertebral Fractures Using Vertebral Body Stenting (Completed, started 2009-09-01)
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.
- Synthes (Usa) (407 510(k)s)
- Synthes Spine (54 510(k)s)
- Synthes (USA) Products, LLC (45 510(k)s)
- Synthes USA Products, LLC (16 510(k)s)
- Synthes USA (11 510(k)s)
- Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. (5 510(k)s)
- Synthes (Usa) Products, LLC/Norian Corporation (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Synthes?
FDA lists 26 510(k) clearances under the applicant name “Synthes” (first 1998, latest 2026), across 14 product codes in 5 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 Synthes?
The median time from FDA receipt to decision across 510(k)s cleared under the name Synthes is 146 days. Since 2017: 146 days, versus 99 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Synthes?
The most frequent FDA product codes under this applicant name are HRS (Plate, Fixation, Bone, 9); JEY (Plate, Bone, 4); GXQ (Dura Substitute, 2).
Next steps
- See all 26 Synthes clearances with predicates and recalls
- Run predicate analysis for product code HRS, Synthes'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.