Cleared Traditional

SUPER SCREW 3.5 MM (K954330) - FDA 510(k) Clearance

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

K954330 · Osteomed Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1995
Decision
84d
Days
Class 2
Risk

K954330 is an FDA 510(k) clearance for the SUPER SCREW 3.5 MM. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Osteomed Corp. (Irving, US). The FDA issued a Cleared decision on December 8, 1995 after a review of 84 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Osteomed Corp. devices

Submission Details

510(k) Number K954330 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 1995
Decision Date December 08, 1995
Days to Decision 84 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
38d faster than avg
Panel avg: 122d · This submission: 84d
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 402
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K954330.
DEPUY M. KUROSAKA ADVANGE MANGNUM REV. INTERFERENCE SCREWS
K960704 · Depuy, Inc. · Jun 1996
CANNULATED PLUS HIP SCREW (STERILE)
K955837 · Wrightmedicaltechnologyinc · Mar 1996
ARTHREX BIOABSORBABLE INTERFERENCE SCREW
K945303 · Arthrex, Inc. · Jan 1996
DEPUY STAINLESS STEEL SET SCREW
K953650 · Depuy, Inc. · Nov 1995
SYNTHES (USA) [SYNTHES[ SELF-DRILLING SCHANZ SCREW
K952296 · Synthes (Usa) · Aug 1995
TI. ALLOY 2.0 MM CORTEX SCREW
K952272 · Synthes (Usa) · Jul 1995