Atlas FDA

The Acumed Wrist Fixation System - Plates; The Acumed Wrist Fixation System - Screws

FDA 510(k) clearance K251132 · decided 2025-07-14

Clearance details

K-number
K251132
Device name
The Acumed Wrist Fixation System - Plates; The Acumed Wrist Fixation System - Screws
Applicant
Acumed, LLC
Decision
Substantially Equivalent
Date received
2025-04-11
Decision date
2025-07-14
Days to decision
94 days
Clearance type
Abbreviated
Product code
HRS
Device class
2
Regulation number
888.3030
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Hillsboro, OR, US
Third-party review
No
Expedited review
No

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Devices cleared under the same product code - the starting set for predicate research.

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Exalta Proximal Tibia Plating System (K261207)Tyber Medical, LLC2026-06-12
APTUS Clavicle System 2.8 (K260761)Medartis AG2026-06-05
Pectus Blu System (K261002)Biomet Microfixation2026-06-02
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Recalls involving this device

RecordFirmDate
Acumed Hexalob Screw various sizes: REF Numbers: : 3070-27008 2.7mm x 8mm NL Hexalobe Scre recall (Z-2532-2026)Acumed LLC2026-06-23