Revolution Radial Head— 510(k) K183618

Name: FDA 510(k) clearance K183618
Creator: U.S. Food and Drug Administration
Published: 2019-05-17

Substantially Equivalent

Ignite Orthopedics, Inc.

FDA 510(k) clearance K183618 for Revolution Radial Head, Substantially Equivalent on 2019-05-17. Applicant: Ignite Orthopedics, Inc.. Device class: 2.

Clearance details

Applicant: Ignite Orthopedics, Inc.
Product code: Code KWI
Device class: Class 2
Regulation: 21 CFR 888.3170
Advisory panel: Orthopedic
Date received: 2018-12-26
Decision date: 2019-05-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warsaw, IN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KWI

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K260624 — Arthrex Radial Head Replacement System2026-07-30
K233592 — BioPoly Radial Head Implant2024-03-13
K231188 — ALIGN Radial Head System2023-09-28
K213563 — DePuy Synthes Radial Head Replacement System2022-03-18
K212872 — Avenger Radial Head System2021-12-17

Adverse events under product code KWI

product code KWI

Injury: 490
Total: 490

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 K183618

K-number listed on FDA's recall record

Z-1072-2022 — Radial Head Replacement System Implant is a one-piece, stemmed radial head replacement. The radial head is available in diameters of 19, 22 and 25mm. The radial stems range from 5.5 to 8.5mm in diameter and from 21 24mm in length.Class II·Ongoing·Synthes (USA) Products LLC·20220407

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K183618.

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