Paragon 28, Inc.: FDA filings under this applicant name
FDA lists 60 510(k) clearances under 2 spellings of the applicant name “Paragon 28, Inc.” (first 2014, latest 2026), across 10 product codes in 1 review panel. Median 510(k) review time under this name: 72 days. Since 2017 the median was 74 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 Zimmer Biomet, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2014 | 1 | 58 |
| 2015 | 2 | 38 |
| 2016 | 0 | — |
| 2017 | 4 | 110 |
| 2018 | 2 | 150 |
| 2019 | 7 | 66 |
| 2020 | 7 | 86 |
| 2021 | 8 | 96 |
| 2022 | 5 | 30 |
| 2023 | 7 | 90 |
| 2024 | 6 | 52 |
| 2025 | 6 | 56 |
| 2026 | 5 | 103 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Paragon 28, Inc. took a median 74 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 |
|---|---|---|---|
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | 13 | 13 |
| HRS | Plate, Fixation, Bone | 8 | 8 |
| HSB | Rod, Fixation, Intramedullary And Accessories | 8 | 8 |
| HWC | Screw, Fixation, Bone | 8 | 8 |
| HSN | Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer | 7 | 7 |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | 6 | 6 |
| JDR | Staple, Fixation, Bone | 4 | 4 |
| HTY | Pin, Fixation, Smooth | 3 | 3 |
| PLF | Bone Wedge | 2 | 2 |
| KTW | Appliance, Fixation, Nail/Blade/Plate Combination, Single Component | 1 | 1 |
Review panels
- Orthopedic (60)
Most recent Paragon 28, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K262722 | Primal K-Wire (P99-193-1410) | HTY | 2026-08-28 | 28 |
| K261121 | Megalodon Dynamic Compression System | JDR | 2026-08-06 | 125 |
| K262047 | Grappler Suture Anchor System | MBI | 2026-08-03 | 46 |
| K253886 | Grappler Suture Anchor PCFD Tether System | MBI | 2026-03-17 | 103 |
| K253591 | Phantom® Hindfoot TTC/TC Nail System | HSB | 2026-03-05 | 108 |
| K253613 | Monkey Rings External Ring Fixation System | KTT | 2025-12-19 | 31 |
| K252106 | External Fixation Mini Rail System | KTT | 2025-09-30 | 89 |
| K251862 | External Fixation Bone Distractor | KTT | 2025-08-11 | 55 |
| K250952 | Baby Gorilla®/Gorilla® Plating System | HRS | 2025-07-18 | 112 |
| K251850 | Phantom® Hindfoot TTC/TC Nail System | HSB | 2025-07-14 | 28 |
50 earlier clearances. See the full list in Caduvo.
Recalls
13 product recalls in 10 recall events; 10 initiated in the last five years. Most recent: 2026-07-10.
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.
Device clinical trials
An industry sponsor named Paragon 28, Inc. is the lead sponsor of 5 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:
- NCT05364606: Patient Specific Talus Spacer Post Approval Study (Recruiting, started 2022-07-08)
- NCT05190159: Monster Screw System Post-Market Clinical Follow-Up Study (Completed, started 2022-01-26)
- NCT05190874: Grappler Interference Screw Post-Market Collection of Patient Reported Outcome Measures (Completed, started 2022-01-14)
- NCT04893824: Grappler® Interference Screw Post-Market Clinical Follow-Up Study (Completed, started 2021-04-19)
- NCT04084262: Multi-Plane Hallux Valgus Correction With the Phantom® Nail (Completed, started 2019-11-07)
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:
- Paragon 28, Inc. (53)
- Paragon 28 (7)
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.
- Paragon Vision Sciences (16 510(k)s)
- Paragon Trade Brands, Inc. (14 510(k)s)
- Paragon Diagnostics, Inc. (7 510(k)s)
- Paragon Implant Mfg., LLC (5 510(k)s)
- Paragon Medical (5 510(k)s)
- Paragon Optical Co. (1 510(k)s)
- Paragon Bioteck, Inc. (1 510(k)s)
- Paragon Medical and Scientific, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Paragon 28, Inc.?
FDA lists 60 510(k) clearances under 2 spellings of the applicant name “Paragon 28, Inc.” (first 2014, latest 2026), across 10 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 Paragon 28, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Paragon 28, Inc. is 72 days. Since 2017: 74 days, versus 94 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Paragon 28, Inc.?
The most frequent FDA product codes under this applicant name are MBI (Fastener, Fixation, Nondegradable, Soft Tissue, 13); HRS (Plate, Fixation, Bone, 8); HSB (Rod, Fixation, Intramedullary And Accessories, 8).
Next steps
- See all 60 Paragon 28, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MBI, Paragon 28, Inc.'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.