Synthes (Usa): FDA filings under this applicant name
FDA lists 411 510(k) clearances under 2 spellings of the applicant name “Synthes (Usa)” (first 1977, latest 2015), plus 1 PMA decision, across 54 product codes in 6 review panels. Median 510(k) review time under this name: 77 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 | 5 | 61 |
| 2013 | 0 | — |
| 2014 | 1 | 276 |
| 2015 | 1 | 294 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HRS | Plate, Fixation, Bone | 93 | 93 |
| JEY | Plate, Bone | 38 | 38 |
| HWC | Screw, Fixation, Bone | 31 | 31 |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | 31 | 31 |
| HSB | Rod, Fixation, Intramedullary And Accessories | 23 | 23 |
| KWP | Appliance, Fixation, Spinal Interlaminal | 17 | 17 |
| LXT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite | 14 | 14 |
| DZL | Screw, Fixation, Intraosseous | 13 | 13 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 12 | 12 |
| MQN | External Mandibular Fixator And/Or Distractor | 12 | 12 |
Plus 44 more product codes.
Review panels
- Orthopedic (318)
- Dental (71)
- Neurology (15)
- General and Plastic Surgery (5)
- Physical Medicine (2)
- General Hospital (1)
Most recent Synthes (Usa) 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K141527 | DEPUY SYNTHES VARIABLE ANGLE LOCKING HAND SYSTEM | HRS | 2015-03-30 | 294 |
| K131984 | SYNTHES SYNSONIC ULNA NAIL | HSB | 2014-03-31 | 276 |
| K121601 | SYNTHES 2.7/3.5MM VARIABLE ANGLE LCP ANKLE TRAUMA SYSTEM-ANTEROLATERAL DISTAL TIBIA PLATE | HRS | 2012-07-06 | 35 |
| K120854 | SYNTHES VA LCP ANKLE TRAUMA SYSTEM | HRS | 2012-06-18 | 89 |
| K120717 | SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM (MEDICAL AND POSTEROLATERAL DISTAL HUMERUS PLATES) | HRS | 2012-05-08 | 61 |
| K120070 | SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM | HRS | 2012-03-21 | 72 |
| K120083 | SET SCREW FOR TI TROCHANTERIC FIXATION NAIL(TFN) | HSB | 2012-02-08 | 28 |
| K111667 | SYNTHES SUPRAPATELLAR INSERTION INSTRUMENTS | JDS | 2011-12-05 | 174 |
| K111540 | SYNTHES 3.5MM LCP CLAVICLE PLATE SYSTEM | HRS | 2011-08-08 | 67 |
| K110789 | SYNTHES STERNAL ZIPFIX SYSTEM | JDQ | 2011-07-28 | 128 |
401 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P970010 | PMA | NORIAN SKELETAL REPAIR SYSTEM (SRS) CANCELLOUS BONE CEMENT | 1998-12-23 |
Recalls
4 product recalls in 3 recall events; 0 initiated in the last five years. Most recent: 2017-08-10.
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.
FDA spellings included
FDA records this applicant under 2 spellings (case, punctuation and legal-suffix variants of one name); this page adds them up. Filings per spelling:
- Synthes (Usa) (403)
- Synthes USA (9)
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) Products, LLC (61 510(k)s)
- Synthes Spine (36 510(k)s)
- Synthes (19 510(k)s)
- Synthes Spine Co.Lp (18 510(k)s)
- Synthes GmbH (7 510(k)s)
- Synthes (Usa), LLC (7 510(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)?
FDA lists 411 510(k) clearances under 2 spellings of the applicant name “Synthes (Usa)” (first 1977, latest 2015), plus 1 PMA decision, across 54 product codes in 6 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)?
The median time from FDA receipt to decision across 510(k)s cleared under the name Synthes (Usa) is 77 days.
Which FDA product codes appear under Synthes (Usa)?
The most frequent FDA product codes under this applicant name are HRS (Plate, Fixation, Bone, 93); JEY (Plate, Bone, 38); HWC (Screw, Fixation, Bone, 31).
Next steps
- See all 411 Synthes (Usa) clearances with predicates and recalls
- Run predicate analysis for product code HRS, Synthes (Usa)'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.