Biotech RadarJobs updated

COMPANY

Paragon 28

paragon28.com ↗ · Mountain

FDA-cleared device company

Profile checked Oct 10, 2026

Keywords: Ankle Injuries Syndesmotic Injuries Ankle Inversion Sprain Deltoid Ankle Sprain Achilles Tendon Rupture Flexor Hallucis Longus on the Left Flexor Digitorum Longus on the Left Ankle Sprains Flexor Hallucis Longus on the Right Flexor Digitorum Longus on the Right Arthrodesis Bunion Hallux Valgus Avascular Necrosis of the Talus Foot Injury Flat Foot Lateral Column Lengthening Medial Cuneiform Osteotomy Patient Specific Talus Spacer Grappler® Interference Screw System Monster Screw System Intramedullary Nail Grappler Interference Screw System Small Bone Intramedullary Nail Titan 3D Wedge System

8Trials (company is sponsor)12FDA records (2 yrs)

Timeline

  1. FDA FDA 510(k) clearance: Primal K-Wire (P99-193-1410) — K262722, Aug 28, 2026. Applicant at approval: Paragon 28, Inc. source ↗
  2. FDA FDA 510(k) clearance: Megalodon Dynamic Compression System — K261121, Aug 6, 2026. Applicant at approval: Paragon 28, Inc. source ↗
  3. FDA FDA 510(k) clearance: Grappler Suture Anchor System — K262047, Aug 3, 2026. Applicant at approval: Paragon 28, Inc. source ↗
  4. FDA FDA 510(k) clearance: Grappler Suture Anchor PCFD Tether System — K253886, Mar 17, 2026. Applicant at approval: Paragon 28, Inc. source ↗
  5. FDA FDA 510(k) clearance: Phantom® Hindfoot TTC/TC Nail System — K253591, Mar 5, 2026. Applicant at approval: Paragon 28, Inc. source ↗
  6. FDA FDA 510(k) clearance: Monkey Rings External Ring Fixation System — K253613, Dec 19, 2025. Applicant at approval: Paragon 28, Inc. source ↗
  7. FDA FDA 510(k) clearance: External Fixation Mini Rail System — K252106, Sep 30, 2025. Applicant at approval: Paragon 28, Inc. source ↗
  8. FDA FDA 510(k) clearance: External Fixation Bone Distractor — K251862, Aug 11, 2025. Applicant at approval: Paragon 28, Inc. source ↗
  9. FDA FDA 510(k) clearance: Baby Gorilla®/Gorilla® Plating System — K250952, Jul 18, 2025. Applicant at approval: Paragon 28, Inc. source ↗
  10. FDA FDA 510(k) clearance: Phantom® Hindfoot TTC/TC Nail System — K251850, Jul 14, 2025. Applicant at approval: Paragon 28, Inc. source ↗
  11. FDA FDA 510(k) clearance: APEX 3D Total Ankle Replacement System — K250641, May 1, 2025. Applicant at approval: Paragon 28, Inc. source ↗
  12. FDA FDA 510(k) clearance: Monkey Bars Pin to Bar External Fixation System — K242452, Nov 1, 2024. Applicant at approval: Paragon 28, Inc. source ↗
  13. Trial start —: Patient Specific Talus Spacer Post Approval Study source ↗
  14. Trial start —: Monster Screw System Post-Market Clinical Follow-Up Study source ↗
  15. Trial start —: Grappler Interference Screw Post-Market Collection of Patient Reported Outcome Measures source ↗
  16. Trial start —: Grappler® Interference Screw Post-Market Clinical Follow-Up Study source ↗
  17. Trial start —: Multi-Plane Hallux Valgus Correction With the Phantom® Nail source ↗
  18. Trial start —: An Evaluation Of Healthy Ankle Motion And Morphology source ↗
  19. Trial start —: Evaluation of the Titan 3-D™ Wedge System source ↗
  20. Trial start —: Early Weight-Bearing After Lapidus Arthrodesis source ↗

Upcoming milestones

Estimated primary completion per ClinicalTrials.gov. Dates move.

Clinical trials (lead sponsor) 8

RecordTitlePhaseStatusStartPrimary completion
NCT05364606Patient Specific Talus Spacer Post Approval StudyNot listedRecruitingJul 8, 2022Aug 30, 2033 (estimated)
NCT04893824Grappler® Interference Screw Post-Market Clinical Follow-Up StudyNot listedCompletedApr 19, 2021Mar 11, 2022 (actual)
NCT05190159Monster Screw System Post-Market Clinical Follow-Up StudyNot listedCompletedJan 26, 2022Sep 14, 2022 (actual)
NCT04084262Multi-Plane Hallux Valgus Correction With the Phantom® NailNot listedCompletedNov 7, 2019Apr 1, 2022 (actual)
NCT05190874Grappler Interference Screw Post-Market Collection of Patient Reported Outcome MeasuresNot listedCompletedJan 14, 2022Mar 11, 2022 (actual)
NCT03619382An Evaluation Of Healthy Ankle Motion And MorphologyNot listedCompletedJul 16, 2018May 31, 2020 (actual)
NCT03257540Early Weight-Bearing After Lapidus ArthrodesisNot listedTerminatedOct 31, 2017Aug 31, 2018 (actual)
NCT03421665Evaluation of the Titan 3-D™ Wedge SystemNot listedWithdrawnJun 15, 2018Sep 1, 2022 (estimated)

FDA records (last 2 years)

Connect

See your connections at Paragon 28 on LinkedIn (search by name, results not checked)

LinkedIn shows your 1st and 2nd-degree connections here from your own login, including who could introduce you. Radar doesn't see your connections.

LinkedIn page linked from the company's own site: source · seen 2026-10-12

Feedback