Cleared Traditional

K233531 - OIC FLEX-FIX System

K233531 is an FDA 510(k) clearance for OIC FLEX-FIX System, manufactured by Orthopaedic Implant Company. The device is a Class 2 Orthopedic device with product code HTN cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K233531 · Orthopaedic Implant Company · Orthopedic device
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Feb 2024
Decision
92d
Days
Class 2
Risk

K233531 is an FDA 510(k) clearance for the OIC FLEX-FIX™ System. Classified as Washer, Bolt Nut (product code HTN), Class II - Special Controls.

Submitted by Orthopaedic Implant Company (Reno, US). The FDA issued a Cleared decision on February 2, 2024 after a review of 92 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 Orthopaedic Implant Company devices

FDA 510(k) Submission Details - K233531

510(k) Number K233531 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 2023
Decision Date February 02, 2024
Days to Decision 92 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
30d faster than avg
Panel avg: 122d · This submission: 92d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HTN Device Classification - Class 2, Special Controls

Product Code HTN Washer, Bolt Nut
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 - HTN Washer, Bolt Nut

All 69
Devices cleared under the same product code (HTN) and FDA review panel - the closest regulatory comparables to K233531.
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