TriMed Ripcord Device— 510(k) K220650

Name: FDA 510(k) clearance K220650
Creator: U.S. Food and Drug Administration
Published: 2022-06-01

Substantially Equivalent

TriMed, Inc.

FDA 510(k) clearance K220650 for TriMed Ripcord Device, Substantially Equivalent on 2022-06-01. Applicant: TriMed, Inc.. Device class: 2.

Clearance details

Applicant: TriMed, Inc.
Product code: Code HTN
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 2022-03-07
Decision date: 2022-06-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Clarita, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HTN

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K253115 — LARS ACJ2026-06-10
K252081 — SportLinc Syndesmosis Device2026-03-27
K253727 — Syndesmosis TightRope PRO2025-12-22
K251643 — Synchfix EVT2025-10-29
K251134 — RipCord2025-07-11

More clearances from TriMed, Inc.

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K262344 — Large Compression Screws2026-08-12
K262032 — TriMed Non-Spanning Wrist Fusion Plates (4 models)2026-07-16
K261241 — TriMed Compression Screws2026-05-14
K254002 — TriMed Volar Bearing Plates (6 models)2026-01-15
K252061 — Distal Xtremities System2025-08-20

Adverse events under product code HTN

product code HTN

Injury: 310
Malfunction: 639
Total: 949

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 →

Recalls naming K220650

K-number listed on FDA's recall record

Z-1101-2023 — RipCord Syndesmosis Button, REF: STA001KClass II·Ongoing·TriMed Inc.·20221222

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K220650.

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