Cleared Traditional

K953198 - CORTICELLOUS BONE SCREW

K953198 is an FDA 510(k) clearance for CORTICELLOUS BONE SCREW, manufactured by Hayes Medical, Inc.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 141-day FDA review.

K953198 · Hayes Medical, Inc. · Orthopedic device
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Nov 1995
Decision
141d
Days
Class 2
Risk

K953198 is an FDA 510(k) clearance for the CORTICELLOUS BONE SCREW. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Hayes Medical, Inc. (Sacramento, US). The FDA issued a Cleared decision on November 24, 1995 after a review of 141 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 Hayes Medical, Inc. devices

FDA 510(k) Submission Details - K953198

510(k) Number K953198 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received July 06, 1995
Decision Date November 24, 1995
Days to Decision 141 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
19d slower than avg
Panel avg: 122d · This submission: 141d
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 805
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K953198.
ARTHREX BIOABSORBABLE INTERFERENCE SCREW
K945303 · Arthrex, Inc. · Jan 1996
FIXANO D.D.S. (DOUBLE SLIDING SCREW)
K954757 · Ferguson Medical · Jan 1996
SUPER SCREW 3.5 MM
K954330 · Osteomed Corp. · Dec 1995
DEPUY STAINLESS STEEL SET SCREW
K953650 · Depuy, Inc. · Nov 1995
6.5MM SOLID CANCELLOUS BONE SCREW
K954485 · Ace Medical Co. · Oct 1995
STRYKER ACL INTERFERENCE SCREW SYSTEM
K952460 · Stryker Endoscopy · Sep 1995