Fusion Orthopedics, LLC: FDA filings under this applicant name
FDA lists 13 510(k) clearances under the applicant name “Fusion Orthopedics, LLC” (first 2016, latest 2024), across 6 product codes in 1 review panel. Median 510(k) review time under this name: 162 days. Since 2017 the median was 172 days, against 90 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.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2016 | 1 | 139 |
| 2017 | 2 | 188 |
| 2018 | 2 | 78 |
| 2019 | 3 | 265 |
| 2020 | 2 | 206 |
| 2021 | 1 | 183 |
| 2022 | 1 | 262 |
| 2023 | 0 | — |
| 2024 | 1 | 159 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Fusion Orthopedics, LLC took a median 172 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 |
|---|---|---|---|
| HWC | Screw, Fixation, Bone | 6 | 6 |
| HRS | Plate, Fixation, Bone | 3 | 3 |
| HTN | Washer, Bolt Nut | 1 | 1 |
| JDR | Staple, Fixation, Bone | 1 | 1 |
| KWH | Prosthesis, Toe, Constrained, Polymer | 1 | 1 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | 1 | 1 |
Review panels
- Orthopedic (13)
Most recent Fusion Orthopedics, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K242091 | Bolo Button System | HTN | 2024-12-23 | 159 |
| K211843 | PolyLock Plating System | HRS | 2022-03-04 | 262 |
| K210159 | IntraLock System | HWC | 2021-07-23 | 183 |
| K193377 | TopLock Anchor System | MBI | 2020-11-25 | 356 |
| K202959 | PolyLock Plating System | HRS | 2020-11-24 | 55 |
| K192323 | PolyLock Small Bone Plating System | HRS | 2019-11-18 | 83 |
| K190136 | Fusion Silastic System | KWH | 2019-10-21 | 265 |
| K182342 | IntraLock Lapidus System | HWC | 2019-05-21 | 266 |
| K182684 | HammerTechTM Fixation System | HWC | 2018-11-23 | 58 |
| K181815 | DynaBridge | JDR | 2018-10-15 | 98 |
3 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Fusion Orthopedics, 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.
- Fusion Medical Technologies, Inc. (3 510(k)s)
- Fusion Innovations, LLC (2 510(k)s)
- Fusion Robotics, LLC (2 510(k)s)
- Fusion Orthopedics USA, LLC (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Fusion Orthopedics, LLC?
FDA lists 13 510(k) clearances under the applicant name “Fusion Orthopedics, LLC” (first 2016, latest 2024), across 6 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Fusion Orthopedics, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Fusion Orthopedics, LLC is 162 days. Since 2017: 172 days, versus 90 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Fusion Orthopedics, LLC?
The most frequent FDA product codes under this applicant name are HWC (Screw, Fixation, Bone, 6); HRS (Plate, Fixation, Bone, 3); HTN (Washer, Bolt Nut, 1).
Next steps
- See all 13 Fusion Orthopedics, LLC clearances with predicates and recalls
- Run predicate analysis for product code HWC, Fusion Orthopedics, 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.