Cleared Traditional

K030302 - HBS HEADLESS BONE SCREW

K030302 is an FDA 510(k) clearance for HBS HEADLESS BONE SCREW, manufactured by Schoening & Assoc., Inc.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 191-day FDA review.

K030302 · Schoening & Assoc., Inc. · Orthopedic device
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Aug 2003
Decision
191d
Days
Class 2
Risk

K030302 is an FDA 510(k) clearance for the HBS HEADLESS BONE SCREW. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Schoening & Assoc., Inc. (Littleton, US). The FDA issued a Cleared decision on August 8, 2003 after a review of 191 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 Schoening & Assoc., Inc. devices

FDA 510(k) Submission Details - K030302

510(k) Number K030302 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 2003
Decision Date August 08, 2003
Days to Decision 191 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
69d slower than avg
Panel avg: 122d · This submission: 191d
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 863
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K030302.
ALANTECH GRAFT FIXATION SCREW
K031937 · Arthrocare Corp. · Sep 2003
OSTEOMED SUBTALAR IMPLANT SYSTEM
K031155 · Osteomed LP · Aug 2003
LORENZ 2.4 SELF DRILLING SCREWS
K032228 · Walter Lorenz Surgical, Inc. · Aug 2003
BIORCI SCREW
K032224 · Smith & Nephew, Inc. · Aug 2003
TAG ROD BIORAPTOR SUTURE ANCHOR 7209317, 7209318
K031685 · Smith & Nephew, Inc. · Jul 2003
RAPIDFIRE SELF DRILLING SCREWS
K031751 · Walter Lorenz Surgical, Inc. · Jun 2003