Not Cleared Direct

DEN220030 - RemeOs™ Screw LAG Solid (FDA 510(k) Clearance)

Class II Orthopedic device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN220030 · Bioretec, Ltd. · Orthopedic device
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Mar 2023
Decision
329d
Days
Class 2
Risk

DEN220030 is an FDA 510(k) submission (not cleared) for the RemeOs™ Screw LAG Solid. Classified as Absorbable Metallic Bone Fixation Fastener (product code QJD), Class II - Special Controls.

Submitted by Bioretec, Ltd. (Tampere, FI). The FDA issued a Not Cleared (DENG) decision on March 29, 2023 after a review of 329 days.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3041 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. High predicate equivalence gap. With 329 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

View all Bioretec, Ltd. devices

Submission Details

510(k) Number DEN220030 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received May 04, 2022
Decision Date March 29, 2023
Days to Decision 329 days
Submission Type Direct
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
207d slower than avg
Panel avg: 122d · This submission: 329d
Pathway characteristics

Device Classification

Product Code QJD Absorbable Metallic Bone Fixation Fastener
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3041
Definition An Absorbable Metallic Bone Fixation Fastener Is An Implant, Such As A Bone Screw, Pin, Or Kirschner Wire, Composed Of One Or More Absorbable Metal Or Metal Alloys And Intended To Provide Rigid Bone Fixation Suitable For Osteosynthesis. The Device Is Designed To Fully Absorb After Steosynthesis Is Achieved.
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.