Cleared Traditional

K941866 - PIONEER LABORATORIES CABLE SCREW

K941866 is an FDA 510(k) clearance for PIONEER LABORATORIES CABLE SCREW, manufactured by Pioneer Surgical Technology. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 224-day FDA review.

K941866 · Pioneer Surgical Technology · Orthopedic device
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Nov 1994
Decision
224d
Days
Class 2
Risk

K941866 is an FDA 510(k) clearance for the PIONEER LABORATORIES CABLE SCREW. 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 November 28, 1994 after a review of 224 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

FDA 510(k) Submission Details - K941866

510(k) Number K941866 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 1994
Decision Date November 28, 1994
Days to Decision 224 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
102d slower than avg
Panel avg: 122d · This submission: 224d
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 966
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K941866.
6.2 VITALLIUM ALLOY CANCELLOUS BONE SCREW
K944213 · Howmedica Corp. · Dec 1994
CORTICAL BONE SCREW
K942340 · Acu Med, Inc. · Dec 1994
CANNULATED CANCELLOUS BONE SCREW
K942341 · Acu Med, Inc. · Dec 1994
PIONEER LABORATORIES BONE SCREW
K940690 · Pioneer Surgical Technology · Nov 1994
AIMS CANNULATED ACL SCREW
K943539 · Smith & Nephew, Inc. · Oct 1994
MITEK CANCELLOUS FIXATION SCREW, CORTICAL FIXATION SCREW, SOFT TISSUE WASHER
K934366 · Mitek Surgical Products, Inc. · Oct 1994