JAWS(TM) Nitinol Staple System— 510(k) K170923

Clearance details

Applicant

Paragon 28

Product code

Code JDR

Device class

Class 2

Regulation

21 CFR 888.3030

Advisory panel

Orthopedic

Date received

2017-03-29

Decision date

2017-07-24

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Englewood, CO, US

• K262451 — Arthrex DynaNite Staples2026-09-01
• 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

• K171715 — HammerTube System2018-03-05
• K172886 — Breakaway Screw System2017-12-20
• K162241 — TITAN 3-D Wedge System2017-04-03
• K153378 — Monster BITE Screw System2015-12-21
• K151418 — Monster Screw System2015-07-15

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 →

• Z-2261-2018 — P28 JAWS Nitinol Staple System kits are designed for use in an osteotomy, arthrodesis and fragment fixation of bones and joints of the foot including fixation of small bone fragments.Class II·Terminated·Paragon 28, Inc.·20171219

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K170923.