Cleared Traditional

K963433 - THREADED FIXATION PIN

K963433 is an FDA 510(k) clearance for THREADED FIXATION PIN, manufactured by Orthopaedic Biosystems, Ltd.. The device is a Class 2 Orthopedic device with product code JDW cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K963433 · Orthopaedic Biosystems, Ltd. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1996
Decision
68d
Days
Class 2
Risk

K963433 is an FDA 510(k) clearance for the THREADED FIXATION PIN. Classified as Pin, Fixation, Threaded (product code JDW), Class II - Special Controls.

Submitted by Orthopaedic Biosystems, Ltd. (Scotsdale, US). The FDA issued a Cleared decision on November 6, 1996 after a review of 68 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 Orthopaedic Biosystems, Ltd. devices

FDA 510(k) Submission Details - K963433

510(k) Number K963433 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 1996
Decision Date November 06, 1996
Days to Decision 68 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
54d faster than avg
Panel avg: 122d · This submission: 68d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JDW Device Classification - Class 2, Special Controls

Product Code JDW Pin, Fixation, Threaded
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 - JDW Pin, Fixation, Threaded

All 77
Devices cleared under the same product code (JDW) and FDA review panel - the closest regulatory comparables to K963433.
PROXIMAL FEMORAL NAIL (PFN) SYSTEM
K970097 · Synthes (Usa) · Mar 1997
HANSSON PIN SYSTEM
K964893 · Osteonics Corp. · Feb 1997
DEPUY CANNULATED CROSS PIN SCREW SYSTEM
K963973 · Depuy, Inc. · Dec 1996
CROSS PIN
K961920 · Medicinelodge, Inc. · Sep 1996
ORTHOFIX MODULSYSTEM
K955848 · Orthofix, Inc. · Mar 1996
KIRSHNER WIRES (K-WIRE) & STEINMANN PINS
K960023 · Promex, Inc. · Mar 1996