ACUMED ANATOMIC RADIAL HEAD SYSTEM, ACUMED ANATOMIC RADIAL HEAD LONG STEMS, ACUMED ARH SLIDE-LOC— 510(k) K131845

Name: FDA 510(k) clearance K131845
Creator: U.S. Food and Drug Administration
Published: 2013-09-30

Substantially Equivalent

Acumed, LLC

FDA 510(k) clearance K131845 for ACUMED ANATOMIC RADIAL HEAD SYSTEM, ACUMED ANATOMIC RADIAL HEAD LONG STEMS, ACUMED ARH SLIDE-LOC, Substantially Equivalent on 2013-09-30. Applicant: Acumed, LLC. Device class: 2.

Clearance details

Applicant: Acumed, LLC
Product code: Code KWI
Device class: Class 2
Regulation: 21 CFR 888.3170
Advisory panel: Orthopedic
Date received: 2013-06-21
Decision date: 2013-09-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hillsboro, OR, 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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K243624 — Acu-Sinch Knotless Mini2025-01-23
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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 K131845

K-number listed on FDA's recall record

Z-2197-2017 — The Acumed Slide-Loc Anatomic Radial Head System is intended for use by surgeons with orthopedic training. The device is to be implanted by the surgeon in a sterile operating room setting. Implants are provided in sterile packages. The Acumed Anatomic Radial Head Slide-Loc System consists of modular heads and stems with accessories for anatomical replacement of the proximal portion of the radius and restore the natural articulation of the radial head with the radial notch of the ulna and capitellum of the distal humerus. The modular heads and stems are single use implantable devices. Each Acumed Slide-Loc Anatomic Radial Head System Set consists of 76 parts/instruments.Class II·Terminated·Acumed LLC·20170420

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K131845.

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