MODULAR RADIAL HEAD— 510(k) K991915

Name: FDA 510(k) clearance K991915
Creator: U.S. Food and Drug Administration
Published: 1999-09-03

Substantially Equivalent

Wrightmedicaltechnologyinc

FDA 510(k) clearance K991915 for MODULAR RADIAL HEAD, Substantially Equivalent on 1999-09-03. Applicant: Wrightmedicaltechnologyinc. Device class: 2.

Clearance details

Applicant: Wrightmedicaltechnologyinc
Product code: Code KWI
Device class: Class 2
Regulation: 21 CFR 888.3170
Advisory panel: Orthopedic
Date received: 1999-06-07
Decision date: 1999-09-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Arlington, TN, 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

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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 K991915

K-number listed on FDA's recall record

Z-0005-2023 — stryker EVOLVE, Proline Stem, CoCr, Size: +2, O: 705mm, REF 496S275, Wright s EVOLVE Proline Plus Radial Head and Repair System is a set configuration designed to address radial head fractures. It combines parts of two systems: EVOLVE Proline and EVOLVE TRIAD.Class II·Ongoing·Wright Medical Technology, Inc.·20220803
Z-0006-2023 — stryker EVOLVE, Proline Stem, CoCr, Size: +4, OD: 9.5mm, REF 496S275, Wright s EVOLVE Proline Plus Radial Head and Repair System is a set configuration designed to address radial head fractures. It combines parts of two systems: EVOLVE Proline and EVOLVE TRIAD.Class II·Ongoing·Wright Medical Technology, Inc.·20220803
Z-2989-2020 — EVOLVE STEM 8.5MM Model # 496S085Class II·Terminated·Wright Medical Technology Inc·20200826

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K991915.

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