Cleared Traditional

K230595 - OsteoCentric ACL Fixation System

K230595 is an FDA 510(k) clearance for OsteoCentric ACL Fixation System, manufactured by OsteoCentric Technologies. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 118-day FDA review.

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

FDA 510(k) Submission Details - K230595

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.

HWC Device Classification - Class 2, Special Controls

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 680
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K230595.
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