Cleared Traditional

K946228 - CROSS PIN SCREW SYSTEM

K946228 is an FDA 510(k) clearance for CROSS PIN SCREW SYSTEM, manufactured by Depuy, Inc.. The device is a Class 2 Orthopedic device with product code JDW cleared through the Traditional 510(k) pathway after a 144-day FDA review.

K946228 · Depuy, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1995
Decision
144d
Days
Class 2
Risk

K946228 is an FDA 510(k) clearance for the CROSS PIN SCREW SYSTEM. Classified as Pin, Fixation, Threaded (product code JDW), Class II - Special Controls.

Submitted by Depuy, Inc. (Warsaw, US). The FDA issued a Cleared decision on May 15, 1995 after a review of 144 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 Depuy, Inc. devices

FDA 510(k) Submission Details - K946228

510(k) Number K946228 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 1994
Decision Date May 15, 1995
Days to Decision 144 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
22d slower than avg
Panel avg: 122d · This submission: 144d
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 84
Devices cleared under the same product code (JDW) and FDA review panel - the closest regulatory comparables to K946228.
RIGIDYNE A EXTERNAL FIXATION SYSTEM
K955780 · Zimmer, Inc. · Feb 1996
DEPUY TITANIUM CROSS PIN FIXATION SYSTEM
K954630 · Depuy, Inc. · Dec 1995
CANNULATED PLUS HIP SCREW
K952640 · Wrightmedicaltechnologyinc · Jul 1995
ORTHOPEDIC THREADED PIN FIXATION
K932349 · Osteomed Corp. · Mar 1994
HAGIE PIN
K905347 · O'Tec Corp. · Jan 1991
STEINMAN PIN, THREADED
K905336 · O'Tec Corp. · Dec 1990