Cleared Traditional

CREED™ Cannulated Screws (K200291) - FDA 510(k) Clearance

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

K200291 · Glw Medical, Inc. · Orthopedic device
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Dec 2020
Decision
315d
Days
Class 2
Risk

K200291 is an FDA 510(k) clearance for the CREED™ Cannulated Screws. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Glw Medical, Inc. (Englewood Cliff, US). The FDA issued a Cleared decision on December 16, 2020 after a review of 315 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Glw Medical, Inc. devices

Submission Details

510(k) Number K200291 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 2020
Decision Date December 16, 2020
Days to Decision 315 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
193d slower than avg
Panel avg: 122d · This submission: 315d
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 Consultant

Wagoner Consulting, LLC
Cheryl Wagoner

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - HWC Screw, Fixation, Bone

All 417
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K200291.
Fixone Biocomposite Interference Screw
K193497 · Aju Pharm Co., Ltd. · Jan 2021
Arthrex Low Profile Screws
K203239 · Arthrex, Inc. · Dec 2020
WishBone Medical Plate and Screw System
K203467 · Wishbone Medical, Inc. · Dec 2020
Monster Screw System
K203011 · Paragon 28, Inc. · Nov 2020
APTUS Cannulated Compression Screws, APTUS headed Cannulated Compression Screws, APTUS K-Wire System
K202589 · Medartis AG · Nov 2020
GEO Bone Screw System
K202817 · Gramercy Extremity Orthopedics, LLC · Oct 2020