Cleared Traditional

OsteoCentric ACL Fixation System (K230595) - FDA 510(k) Clearance

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

K230595 · OsteoCentric Technologies · Orthopedic device
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Jun 2023
Decision
118d
Days
Class 2
Risk

K230595 is an FDA 510(k) clearance for the OsteoCentric ACL Fixation System. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by OsteoCentric Technologies (Logan, US). The FDA issued a Cleared decision on June 29, 2023 after a review of 118 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - 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 OsteoCentric Technologies devices

Submission Details

510(k) Number K230595 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 2023
Decision Date June 29, 2023
Days to Decision 118 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
4d faster than avg
Panel avg: 122d · This submission: 118d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HWC Screw, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
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 - HWC Screw, Fixation, Bone

All 407
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K230595.
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K231236 · In2bones USA, LLC · Jul 2023
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K230945 · Forma Medical, Inc. · Jul 2023
Bone Bolt System
K230867 · University of Utah, Department of Orthopaedics · Jun 2023
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Acumed Acutrak 3 Headless Compression Screw System
K230744 · Acumed, LLC · Jun 2023