Cleared Traditional

K212547 - Quick-Start Screws

K212547 is an FDA 510(k) clearance for Quick-Start Screws, manufactured by Innovate Orthopaedics Limited. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 139-day FDA review.

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

FDA 510(k) Submission Details - K212547

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.

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 K212547.
BRM TOOL Screws
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R3ACT Stabilization System
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K213301 · Nextremity Solutions, Inc. · Dec 2021
OSSIOfiber Compression Screw, 3.5mm
K213596 · OSSIO , Ltd. · Dec 2021