Cleared Traditional

LOCKING BONE SCREW MODEL HCQ04, HCZ04 (K100721) - FDA 510(k) Clearance

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

K100721 · Changzhou Orthmar Medical Instrument Co., Ltd. · Orthopedic device
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Nov 2010
Decision
253d
Days
Class 2
Risk

K100721 is an FDA 510(k) clearance for the LOCKING BONE SCREW MODEL HCQ04, HCZ04. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Changzhou Orthmar Medical Instrument Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on November 23, 2010 after a review of 253 days - an extended review cycle.

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 Changzhou Orthmar Medical Instrument Co., Ltd. devices

Submission Details

510(k) Number K100721 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 2010
Decision Date November 23, 2010
Days to Decision 253 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
131d slower than avg
Panel avg: 122d · This submission: 253d
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 404
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K100721.
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K100359 · Wrightmedicaltechnologyinc · Jun 2010