Cleared Traditional

Fine Osteotomy™ (K250923) - FDA 510(k) Clearance

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

K250923 · Bodycad Laboratories, Inc. · Orthopedic device
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Aug 2025
Decision
147d
Days
Class 2
Risk

K250923 is an FDA 510(k) clearance for the Fine Osteotomy™. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Bodycad Laboratories, Inc. (Quebec, CA). The FDA issued a Cleared decision on August 21, 2025 after a review of 147 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 Bodycad Laboratories, Inc. devices

Submission Details

510(k) Number K250923 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 27, 2025
Decision Date August 21, 2025
Days to Decision 147 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
25d slower than avg
Panel avg: 122d · This submission: 147d
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 697
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K250923.
Fine Osteotomy™
K253300 · Bodycad Laboratories, Inc. · Oct 2025
Pediatric Plating Platform I Small-Mini
K252600 · OrthoPediatrics Corp. · Oct 2025
MAXXOS P.A.C.E. Foot & Ankle Plating System
K251892 · Maxxos Medical GmbH · Sep 2025
Treace Medical Concepts (TMC) Implant Fixation System
K251135 · Treace Medical Concepts · Aug 2025
The Acumed Wrist Fixation System - 2.4mm Screws
K252356 · Acumed, LLC · Aug 2025
Distal Xtremities System
K252061 · TriMed, Inc. · Aug 2025