Cleared Traditional

PIONEER LABORATORIES BONE PLATE WITH CERCLAGE CABLES (K940729) - FDA 510(k) Clearance

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

K940729 · Pioneer Surgical Technology · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1994
Decision
306d
Days
Class 2
Risk

K940729 is an FDA 510(k) clearance for the PIONEER LABORATORIES BONE PLATE WITH CERCLAGE CABLES. Classified as Cerclage, Fixation (product code JDQ), Class II - Special Controls.

Submitted by Pioneer Surgical Technology (Marquette,, US). The FDA issued a Cleared decision on December 21, 1994 after a review of 306 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3010 - 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. Elevated predicate reliance profile. 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 K940729 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 18, 1994
Decision Date December 21, 1994
Days to Decision 306 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
184d slower than avg
Panel avg: 122d · This submission: 306d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JDQ Cerclage, Fixation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3010
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 - JDQ Cerclage, Fixation

All 50
Devices cleared under the same product code (JDQ) and FDA review panel - the closest regulatory comparables to K940729.
SYNTHES WIRE MOUNT
K953777 · Synthes (Usa) · Mar 1996
DALL-MILES SUTURE/BEADED CABLE
K953818 · Howmedica Corp. · Oct 1995
DALL MILES SYSTEM HOMOGENEOUS VITALLIUM CABLE
K945294 · Howmedica Corp. · Mar 1995
DALL MILES SYSTEM GROOVED BUTTON
K934059 · Howmedica Corp. · Aug 1994
CONTROL CABLE SYSTEM
K934557 · Depuy, Inc. · Feb 1994
DALL MILES SYSTEM MINICLEAT
K934058 · Howmedica Corp. · Feb 1994