Cleared Traditional

PIONEER LABORATORIES CABLE PIN (K941174) - FDA 510(k) Clearance

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

K941174 · Pioneer Surgical Technology · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1994
Decision
189d
Days
Class 2
Risk

K941174 is an FDA 510(k) clearance for the PIONEER LABORATORIES CABLE PIN. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Pioneer Surgical Technology (Marquette, US). The FDA issued a Cleared decision on September 19, 1994 after a review of 189 days - an extended review 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: 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 Pioneer Surgical Technology devices

Submission Details

510(k) Number K941174 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 1994
Decision Date September 19, 1994
Days to Decision 189 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
67d slower than avg
Panel avg: 122d · This submission: 189d
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 403
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K941174.
BONE MULCH SCREW
K941941 · Biomet, Inc. · Feb 1995
6.2 VITALLIUM ALLOY CANCELLOUS BONE SCREW
K944213 · Howmedica Corp. · Dec 1994
AIMS CANNULATED ACL SCREW
K943539 · Smith & Nephew, Inc. · Oct 1994
ARTHROTEK SET SCREW
K932721 · Biomet, Inc. · Aug 1994
TITANIUM ALLOY BONE SCREWS
K940207 · Aesculap, Inc. · Jul 1994
FULLY THREADED ALTA CANCELLOUS BONE SCREW
K931524 · Howmedica Corp. · Mar 1994