Cleared Abbreviated

K240958 - Locking Plates and Screws Systems (FDA 510(k) Clearance)

Class II Orthopedic device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K240958 · Hebei Ruihe Medical Devices Co., Ltd. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2025
Decision
308d
Days
Class 2
Risk

K240958 is an FDA 510(k) clearance for the Locking Plates and Screws Systems. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Hebei Ruihe Medical Devices Co., Ltd. (Shijiazhuang, CN). The FDA issued a Cleared decision on February 10, 2025 after a review of 308 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Hebei Ruihe Medical Devices Co., Ltd. devices

Submission Details

510(k) Number K240958 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 2024
Decision Date February 10, 2025
Days to Decision 308 days
Submission Type Abbreviated
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
186d slower than avg
Panel avg: 122d · This submission: 308d
Pathway characteristics
Standards-based clearance path.

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 1306
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K240958.
OrthoPediatrics® Locking Cannulated Blade Plate System
K260323 · OrthoPediatrics Corp. · Apr 2026
PC Fix System
K260411 · Chest Wall Innovations, Inc. · Apr 2026
POYA 3.5mm Medial Proximal Tibia System
K260228 · Bonebridge AG · Apr 2026
I.T.S. PRS Phoenix II
K260054 · I.T.S. GmbH · Apr 2026
SMART Osteotomy System
K260090 · Actis Medical Pty., Ltd. · Apr 2026
enHAnce PEEK Bunion System
K253718 · Nvision Biomedical Technologies, Inc. · Apr 2026