Cleared Traditional

K962987 - EZ-FIX SMALL CANNULATED SCREW SYSTEM

K962987 is an FDA 510(k) clearance for EZ-FIX SMALL CANNULATED SCREW SYSTEM, manufactured by Biodynamic Technologies, Inc.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K962987 · Biodynamic Technologies, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1996
Decision
95d
Days
Class 2
Risk

K962987 is an FDA 510(k) clearance for the EZ-FIX SMALL CANNULATED SCREW SYSTEM. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Biodynamic Technologies, Inc. (Deerfield Beach, US). The FDA issued a Cleared decision on November 4, 1996 after a review of 95 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 Biodynamic Technologies, Inc. devices

FDA 510(k) Submission Details - K962987

510(k) Number K962987 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 1996
Decision Date November 04, 1996
Days to Decision 95 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
27d faster than avg
Panel avg: 122d · This submission: 95d
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 680
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K962987.
EZ-FIX CANNULATED SCREW SYSTEM
K962706 · Biodynamic Technologies, Inc. · Nov 1996
SYNTHES STERILE 4.5 MM CANNULATED SCREWS
K963172 · Synthes (Usa) · Nov 1996
SYNTHES STERILE 3.5 MM AND 4.0 MM CANNULATED SCREWS
K963192 · Synthes (Usa) · Nov 1996
EXTREMITY BONE SCREW
K963118 · Acu Med, Inc. · Oct 1996
ALTA FULLY THREADED CROSS-LOCKING SCREWS
K963398 · Howmedica Corp. · Oct 1996
SYNTHES STERILE 3.0 MM CANNULATED SCREW AND THREADED WASHER
K962823 · Synthes (Usa) · Oct 1996