Synthes USA Products, LLC: FDA filings under this applicant name
FDA lists 16 510(k) clearances under the applicant name “Synthes USA Products, LLC” (first 2010, latest 2018), across 11 product codes in 3 review panels. Median 510(k) review time under this name: 112 days. Since 2017 the median was 248 days, against 94 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 | 1 | 112 |
| 2013 | 1 | 90 |
| 2014 | 2 | 58 |
| 2015 | 3 | 112 |
| 2016 | 1 | 70 |
| 2017 | 4 | 241 |
| 2018 | 1 | 265 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Synthes USA Products, LLC took a median 248 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 94 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HWC | Screw, Fixation, Bone | 3 | 3 |
| KWP | Appliance, Fixation, Spinal Interlaminal | 2 | 2 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | 2 |
| MQN | External Mandibular Fixator And/Or Distractor | 2 | 2 |
| GXP | Methyl Methacrylate For Cranioplasty | 1 | 1 |
| HSB | Rod, Fixation, Intramedullary And Accessories | 1 | 1 |
| MQV | Filler, Bone Void, Calcium Compound | 1 | 1 |
| MTJ | Wax, Bone | 1 | 1 |
| NKB | Thoracolumbosacral Pedicle Screw System | 1 | 1 |
| NKG | Posterior Cervical Screw System | 1 | 1 |
Plus 1 more product codes.
Review panels
- Orthopedic (12)
- Dental (2)
- Neurology (2)
Most recent Synthes USA Products, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K180541 | DePuy Synthes 2.0 mm Quick Insertion Screws | HWC | 2018-11-21 | 265 |
| K170818 | Craniomaxillofacial Distraction System (CMFD) | PBJ | 2017-12-07 | 262 |
| K162594 | Craniomaxillofacial Distraction System (CMFD) | MQN | 2017-05-08 | 234 |
| K170654 | USS System | NKB | 2017-03-29 | 26 |
| K161616 | DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated Screws, DePuy Synthes 3.5 mm and 4.0 mm Cannulated Screws, DePuy Synthes 4.5 mm Cannulated Screws, DePuy Synthes 6.5 mm Cannulated Screws, DePuy Synthes 7.0 mm and 7.3 mm Cannulated Screws, DePuy Synthes 1.5 mm Headless Compression Screws, DePuy Synthes 2.4 mm Headless Compression Screws, DePuy Synthes 3.0 mm Headless Compression Screws, DePuy Synthes 4.5 mm and 6.5 mm Headless Compression Screw | HWC | 2017-02-16 | 248 |
| K162358 | T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution System | MAX | 2016-11-01 | 70 |
| K151276 | DePuy Synthes T-PAL Ti Spacer | MAX | 2015-06-18 | 36 |
| K143285 | Mandible External Fixator - MR Conditional | MQN | 2015-05-28 | 192 |
| K142838 | Synapse Occipital-Cervical-Thoracic (OCT) System | NKG | 2015-01-20 | 112 |
| K141897 | SYNAPSE SYSTEM, SYNTHES OC FUSION SYSTEM | KWP | 2014-09-25 | 73 |
6 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Synthes USA Products, LLC.
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.
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 (26 510(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 USA Products, LLC?
FDA lists 16 510(k) clearances under the applicant name “Synthes USA Products, LLC” (first 2010, latest 2018), across 11 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 Synthes USA Products, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Synthes USA Products, LLC is 112 days. Since 2017: 248 days, versus 94 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Synthes USA Products, LLC?
The most frequent FDA product codes under this applicant name are HWC (Screw, Fixation, Bone, 3); KWP (Appliance, Fixation, Spinal Interlaminal, 2); MAX (Intervertebral Fusion Device With Bone Graft, Lumbar, 2).
Next steps
- See all 16 Synthes USA Products, LLC clearances with predicates and recalls
- Run predicate analysis for product code HWC, Synthes USA Products, LLC'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.