Monkey RingsTM External Fixation System— 510(k) K232838

Name: FDA 510(k) clearance K232838
Creator: U.S. Food and Drug Administration
Published: 2023-10-12

Substantially Equivalent

Paragon 28, Inc.

FDA 510(k) clearance K232838 for Monkey RingsTM External Fixation System, Substantially Equivalent on 2023-10-12. Applicant: Paragon 28, Inc.. Device class: 2.

Clearance details

Applicant: Paragon 28, Inc.
Product code: Code KTT
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 2023-09-14
Decision date: 2023-10-12
Decision: Substantially Equivalent
Clearance type: Special
Location: Englewood, CO, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KTT

view all

K254087 — MAXFRAME AUTOSTRUT with Bluetooth Multi-Axial Correction System2026-06-11
K260900 — DYNEX® External Fixation Systems2026-04-17
K260112 — QuikFix External Fixator: Knee-Spanning Pack2026-03-23
K253291 — Excelsior System2026-01-20
K253202 — Hoffmann LRF System2025-12-19

More clearances from Paragon 28, Inc.

view all

K262722 — Primal K-Wire (P99-193-1410)2026-08-28
K261121 — Megalodon Dynamic Compression System2026-08-06
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

Adverse events under product code KTT

product code KTT

Death: 11
Injury: 3,097
Malfunction: 1,261
Total: 4,369

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.