Cleared Traditional

K940666 - JBS SMOOTH FIXATION PIN

K940666 is an FDA 510(k) clearance for JBS SMOOTH FIXATION PIN, manufactured by J.B.S., S.A.. The device is a Class 2 Orthopedic device with product code HTY cleared through the Traditional 510(k) pathway after a 271-day FDA review.

K940666 · J.B.S., S.A. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1994
Decision
271d
Days
Class 2
Risk

K940666 is an FDA 510(k) clearance for the JBS SMOOTH FIXATION PIN. Classified as Pin, Fixation, Smooth (product code HTY), Class II - Special Controls.

Submitted by J.B.S., S.A. (Foster City, US). The FDA issued a Cleared decision on November 14, 1994 after a review of 271 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 J.B.S., S.A. devices

FDA 510(k) Submission Details - K940666

510(k) Number K940666 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 16, 1994
Decision Date November 14, 1994
Days to Decision 271 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
149d slower than avg
Panel avg: 122d · This submission: 271d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HTY Device Classification - Class 2, Special Controls

Product Code HTY Pin, Fixation, Smooth
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 - HTY Pin, Fixation, Smooth

All 160
Devices cleared under the same product code (HTY) and FDA review panel - the closest regulatory comparables to K940666.
SPETZLER PIN
K954001 · Howmedica Corp. · Oct 1995
FIXATION PINS/WIRES
K943856 · Acu Med, Inc. · Jul 1995
SPETZLER PIN
K945639 · Howmedica Corp. · Apr 1995
ACUFEX SMOOTH AND THREADED PINS
K931836 · Acufex Microsurgical, Inc. · Jun 1994
ORTHOPEDIC SMOOTH PIN FIXATION
K932348 · Osteomed Corp. · Mar 1994
ACUFEX BIOFIX ABSORBABLE FIXATION ROD-MODIFICATION
K922766 · Acufex Microsurgical, Inc. · Jul 1993