Cleared Traditional

K233311 - Acumed Wrist Plating System

K233311 is the FDA 510(k) clearance for Acumed Wrist Plating System by Acumed, LLC. It is a Class 2 Orthopedic device (product code HRS) cleared through the Traditional 510(k) pathway after a 206-day FDA review.

K233311 · Acumed, LLC · Orthopedic device
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Apr 2024
Decision
206d
Days
Class 2
Risk

K233311 is an FDA 510(k) clearance for the Acumed Wrist Plating System. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Acumed, LLC (Hillsboro, US). The FDA issued a Cleared decision on April 22, 2024 after a review of 206 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Acumed, LLC devices

Submission Details

510(k) Number K233311 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2023
Decision Date April 22, 2024
Days to Decision 206 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
84d slower than avg
Panel avg: 122d · This submission: 206d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HRS Plate, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - HRS Plate, Fixation, Bone

All 885
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K233311.
NeoSpan® Compression Implant System
K233089 · In2bones USA, LLC · May 2024
DePuy Synthes MatrixSTERNUM Fixation System
K233967 · Synthes GmbH · May 2024
XLO Brand of Locking Distal Humerus Plating System
K233873 · Ortho Life Systems Private Limited · Apr 2024
APTUS Foot System 2.8-3.5
K232105 · Medartis AG · Apr 2024
TriMed ASET Foot Plating System (1ST MTP 9-hole Long Plate), TriMed ASET Foot Plating System (1st Met Osteotomy Plate), TriMed ASET Foot Plating System (H-Plate), TriMed ASET Foot Plating System (Talonavicular Plate), TriMed ASET Foot Plating System (Calcaneal Slide Osteotomy Plate), TriMed ASET Foot Plating System (Evans Osteotomy Plate), TriMed ASET Foot Plating System (Medial Column Fusion Plate), TriMed ASET Foot Plating System (Straight Plate), TriMed ASET Foot Plating System (T-
K233863 · TriMed, Inc. · Apr 2024
Fine Osteotomy™
K240703 · Bodycad Laboratories, Inc. · Apr 2024