Cleared Traditional

K211612 - Medline UNITE REFLEX Dynamic Discs (FDA 510(k) Clearance)

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

K211612 · Medline Industries, Inc. · Orthopedic device
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Dec 2021
Decision
198d
Days
Class 2
Risk

K211612 is an FDA 510(k) clearance for the Medline UNITE REFLEX Dynamic Discs. Classified as Washer, Bolt Nut (product code HTN), Class II - Special Controls.

Submitted by Medline Industries, Inc. (Northfiled, US). The FDA issued a Cleared decision on December 10, 2021 after a review of 198 days - an extended review cycle.

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 Medline Industries, Inc. devices

Submission Details

510(k) Number K211612 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 26, 2021
Decision Date December 10, 2021
Days to Decision 198 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
76d slower than avg
Panel avg: 122d · This submission: 198d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 91
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