Additive Orthopaedics, LLC: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Additive Orthopaedics, LLC” (first 2016, latest 2022), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 120 days. Since 2017 the median was 107 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.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2016 | 2 | 214 |
| 2017 | 2 | 130 |
| 2018 | 1 | 107 |
| 2019 | 1 | 71 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 1 | 442 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Additive Orthopaedics, LLC took a median 107 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 |
|---|---|---|---|
| HRS | Plate, Fixation, Bone | 5 | 5 |
| HTY | Pin, Fixation, Smooth | 1 | 1 |
| PBF | Orthopaedic Surgical Planning And Instrument Guides | 1 | 1 |
Review panels
- Orthopedic (7)
Most recent Additive Orthopaedics, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K211076 | Patient Specific Marking Guides | PBF | 2022-06-28 | 442 |
| K183011 | Additive Orthopaedics Patient Specific 3D Locking Lattice Plates | HRS | 2019-01-10 | 71 |
| K180239 | Additive Orthopaedics Patient Specific 3D Printed Bone Segments | HRS | 2018-05-16 | 107 |
| K163593 | Additive Orthopaedics Bunion System | HRS | 2017-06-20 | 181 |
| K170214 | Additive Orthopaedics Locking Lattice Plate | HRS | 2017-04-13 | 79 |
| K153207 | Additive Orthopaedics Bone Wedge System | HRS | 2016-09-07 | 307 |
| K160264 | Additive Orthopaedics Hammertoe Correction System | HTY | 2016-06-01 | 120 |
Recalls
openFDA lists no recalls under a recalling firm named Additive Orthopaedics, 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.
- Additive Implants, Inc. (3 510(k)s)
- Additive Device, Inc. (Adi) D/B/A Restor3D (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Additive Orthopaedics, LLC?
FDA lists 7 510(k) clearances under the applicant name “Additive Orthopaedics, LLC” (first 2016, latest 2022), across 3 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 Additive Orthopaedics, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Additive Orthopaedics, LLC is 120 days. Since 2017: 107 days, versus 94 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Additive Orthopaedics, LLC?
The most frequent FDA product codes under this applicant name are HRS (Plate, Fixation, Bone, 5); HTY (Pin, Fixation, Smooth, 1); PBF (Orthopaedic Surgical Planning And Instrument Guides, 1).
Next steps
- See all 7 Additive Orthopaedics, LLC clearances with predicates and recalls
- Run predicate analysis for product code HRS, Additive Orthopaedics, 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.