Cleared Traditional

K093055 - CSTS SCREW

K093055 is an FDA 510(k) clearance for CSTS SCREW, manufactured by Orthopro, LLC. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 418-day FDA review.

K093055 · Orthopro, LLC · Orthopedic device
Download Printable Device Report (PDF)
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Nov 2010
Decision
418d
Days
Class 2
Risk

K093055 is an FDA 510(k) clearance for the CSTS SCREW. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Orthopro, LLC (Round Rock, US). The FDA issued a Cleared decision on November 22, 2010 after a review of 418 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Orthopedic submissions.

View all Orthopro, LLC devices

FDA 510(k) Submission Details - K093055

510(k) Number K093055 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2009
Decision Date November 22, 2010
Days to Decision 418 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
296d slower than avg
Panel avg: 122d · This submission: 418d
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 758
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K093055.
GRYPHON PEEK DS ANCHOR W/ ORTHOCORD, GRYPHON PEEK ANCHOR W/ ORTHOCORD
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K102298 · Depuy Mitek, A Johnson & Johnson Company · Jan 2011
MATRYX INTERFERENCE SCREW (5.0-6.5MM)
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PARCUS PEEK CF PUSH-IN SUTURE ANCHOR
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PIONEER CANNULATED SCREW SYSTEM
K102903 · Pioneer Surgical Technology, Inc. · Oct 2010