Cleared Traditional

XLO Brand of Locking Distal Humerus Plating System (K233873) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K233873 · Ortho Life Systems Private Limited · Orthopedic device
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Apr 2024
Decision
141d
Days
Class 2
Risk

K233873 is an FDA 510(k) clearance for the XLO Brand of Locking Distal Humerus 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 Ortho Life Systems Private Limited (Okhla, IN). The FDA issued a Cleared decision on April 26, 2024 after a review of 141 days - within the typical 510(k) review window.

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 Ortho Life Systems Private Limited devices

Submission Details

510(k) Number K233873 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 2023
Decision Date April 26, 2024
Days to Decision 141 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
19d slower than avg
Panel avg: 122d · This submission: 141d
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 700
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K233873.
Tyber Medical Anatomical Plating System
K241218 · Tyber Medical, LLC · May 2024
NeoSpan® Compression Implant System
K233089 · In2bones USA, LLC · May 2024
DePuy Synthes MatrixSTERNUM Fixation System
K233967 · Synthes GmbH · May 2024
Acumed Wrist Plating System
K233311 · Acumed, LLC · 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