Cleared Traditional

K936045 - ACE UNILATERAL FIXATOR II

K936045 is an FDA 510(k) clearance for ACE UNILATERAL FIXATOR II, manufactured by Ace Orthopedic Manufacturing Co.. The device is a Class 2 Orthopedic device with product code JEC cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K936045 · Ace Orthopedic Manufacturing Co. · Orthopedic device
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Feb 1994
Decision
64d
Days
Class 2
Risk

K936045 is an FDA 510(k) clearance for the ACE UNILATERAL FIXATOR II. Classified as Component, Traction, Invasive (product code JEC), Class II - Special Controls.

Submitted by Ace Orthopedic Manufacturing Co. (Los Angeles, US). The FDA issued a Cleared decision on February 22, 1994 after a review of 64 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Ace Orthopedic Manufacturing Co. devices

FDA 510(k) Submission Details - K936045

510(k) Number K936045 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 1993
Decision Date February 22, 1994
Days to Decision 64 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
58d faster than avg
Panel avg: 122d · This submission: 64d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JEC Device Classification - Class 2, Special Controls

Product Code JEC Component, Traction, Invasive
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 - JEC Component, Traction, Invasive

All 56
Devices cleared under the same product code (JEC) and FDA review panel - the closest regulatory comparables to K936045.
ACE PELVIC STABILIZER
K933968 · Ace Medical Co. · Jun 1994
PELVIC C-CLAMP
K922796 · Synthes (Usa) · Mar 1994
HOWMEDICA MONO-TUBE SINGLE PIN CLAMP
K934698 · Howmedica Corp. · Feb 1994
HOWMEDICA MONOTUBE T-CONNECTOR
K936124 · Howmedica, Inc. · Feb 1994
ACE OPEN-BACK HALO RING
K914858 · Ace Medical Co. · Nov 1991
CYPRESS CERVICAL TRACTION EQUIPMENT, CYPRESS HALO
K894959 · Alphatec Mfg., Inc. · Sep 1990