Cleared Traditional

K223150 - APS Metal Plate & Screw System

K223150 is the FDA 510(k) clearance for APS Metal Plate & Screw System by A Plus Biotechnology Co., Ltd.. It is a Class 2 Orthopedic device (product code HRS) cleared through the Traditional 510(k) pathway after a 323-day FDA review.

K223150 · A Plus Biotechnology Co., Ltd. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2023
Decision
323d
Days
Class 2
Risk

K223150 is an FDA 510(k) clearance for the APS Metal Plate & Screw 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 A Plus Biotechnology Co., Ltd. (New Taipei City, TW). The FDA issued a Cleared decision on August 24, 2023 after a review of 323 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 A Plus Biotechnology Co., Ltd. devices

Submission Details

510(k) Number K223150 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 05, 2022
Decision Date August 24, 2023
Days to Decision 323 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
201d slower than avg
Panel avg: 122d · This submission: 323d
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 903
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K223150.
KITE Distal Fibula Kit
K230623 · Intrauma S.P.A · Sep 2023
TriMed Clavicle Fixation System
K230805 · TriMed, Inc. · Sep 2023
Distal Elbow Plating System
K231623 · Skeletal Dynamics, Inc. · Aug 2023
Pangea Utility Plating System, Pangea Platform
K231257 · Stryker GmbH · Aug 2023
Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System, Pangea Humerus Plating System
K231262 · Stryker GmbH · Aug 2023
Sterile Products of the APTUS System
K232144 · Medartis AG · Aug 2023