Cleared Traditional

K946228 - CROSS PIN SCREW SYSTEM

K946228 is the FDA 510(k) clearance for CROSS PIN SCREW SYSTEM by Depuy, Inc.. It is a Class 2 Orthopedic device (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

Submission Details

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.

Device Classification

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 52
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
RUSH PIN
K903261 · Onyx Medical Corp. · Jul 1990
STEINMAN PIN, THREAD
K903266 · Onyx Medical Corp. · Jul 1990
FIXATOR PIN (EXTERNAL)
K881511 · Orthopedic Systems, Inc. · Jun 1988