Cleared Traditional

Quick-Start Screws (K212547) - FDA 510(k) Clearance

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

K212547 · Innovate Orthopaedics Limited · Orthopedic device
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Dec 2021
Decision
139d
Days
Class 2
Risk

K212547 is an FDA 510(k) clearance for the Quick-Start Screws. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Innovate Orthopaedics Limited (Huddersfield, GB). The FDA issued a Cleared decision on December 30, 2021 after a review of 139 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 Innovate Orthopaedics Limited devices

Submission Details

510(k) Number K212547 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 2021
Decision Date December 30, 2021
Days to Decision 139 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
17d slower than avg
Panel avg: 122d · This submission: 139d
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 K212547.
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K213596 · OSSIO , Ltd. · Dec 2021