# Paragon 28 (manufacturer, Englewood, CO): 9 new FDA device listings, incl. kit, surgical instrument, disposable

**Score:** 95/100

| Field | Value |
|---|---|
| Establishment | Paragon 28 |
| Role | Manufacturer |
| Establishment types | Complaint File Establishment per 21 CFR 820.198; Develop Specifications But Do Not Manufacture At This Facility; Manufacture Medical Device; Repack or Relabel Medical Device |
| Location | Englewood, CO, US |
| New listings | 9 |
| Devices | Kit, Surgical Instrument, Disposable; Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer; Fastener, Fixation, Nondegradable, Soft Tissue; Staple, Fixation, Bone; Filler, Bone Void, Osteoinduction (W/O Human Growth Factor); Filler, Bone Void, Calcium Compound; Plate, Fixation, Bone; Screw, Fixation, Bone |
| Product codes | KDD, HSN, MBI, JDR, MBP, MQV, HRS, HWC |
| Device classes | Class I, Class II |
| Medical specialties | General, Plastic Surgery, Orthopedic |
| Brand names | Primal OCD; APEX 3D Total Ankle Replacement System, APEX 3D S Diamond Tibia; Grappler Suture Anchor System; Megalodon Dynamic Compression System; JAWS Nitinol Staple System; BEAST Injectable Putty; DAC Dynamic Active Compression Plate |
| First new listing | 2026-05-12 |
| Latest new listing | 2026-10-08 |
| FDA registration number | 3008650117 |
| Registration expires | 2027-12-31 |

## Why this score
- Brings its own devices to market: buys manufacturing, sterilization and QMS help.
- Class II or III devices: QMS and regulatory demands.
- Several new listings at once.
- U.S. establishment.
- Listed in the last 45 days.

Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm). Last refreshed: 2026-10-28T20:51:27.468Z.
From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.