JAWS Nitinol Staple System— 510(k) K230550

Name: FDA 510(k) clearance K230550
Creator: U.S. Food and Drug Administration
Published: 2023-05-11

Substantially Equivalent

Paragon 28, Inc.

FDA 510(k) clearance K230550 for JAWS Nitinol Staple System, Substantially Equivalent on 2023-05-11. Applicant: Paragon 28, Inc.. Device class: 2.

Clearance details

Applicant: Paragon 28, Inc.
Product code: Code JDR
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 2023-02-28
Decision date: 2023-05-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Englewood, CO, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JDR

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K261121 — Megalodon Dynamic Compression System2026-08-06
K250712 — Linkt Compression Staple System2025-05-14
K243888 — Medline UNITE® REFLEX® Hybrid Nitinol Implant System2025-04-11
K243742 — Arthrex DynaNite Nitinol Staples2025-01-31
K243658 — TMC Compression Implant System2024-12-26

More clearances from Paragon 28, Inc.

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K262722 — Primal K-Wire (P99-193-1410)2026-08-28
K262047 — Grappler Suture Anchor System2026-08-03
K253886 — Grappler Suture Anchor PCFD Tether System2026-03-17
K253591 — Phantom® Hindfoot TTC/TC Nail System2026-03-05
K253613 — Monkey Rings External Ring Fixation System2025-12-19

Adverse events under product code JDR

product code JDR

Injury: 726
Malfunction: 663
Other: 1
Total: 1,390

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.