Cleared Traditional

K933968 - ACE PELVIC STABILIZER

K933968 is an FDA 510(k) clearance for ACE PELVIC STABILIZER, manufactured by Ace Medical Co.. The device is a Class 2 Orthopedic device with product code JEC cleared through the Traditional 510(k) pathway after a 304-day FDA review.

K933968 · Ace Medical Co. · Orthopedic device
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Jun 1994
Decision
304d
Days
Class 2
Risk

K933968 is an FDA 510(k) clearance for the ACE PELVIC STABILIZER. Classified as Component, Traction, Invasive (product code JEC), Class II - Special Controls.

Submitted by Ace Medical Co. (Los Angeles, US). The FDA issued a Cleared decision on June 16, 1994 after a review of 304 days - an unusually long review period, suggesting complex equivalence evaluation.

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. 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 Ace Medical Co. devices

FDA 510(k) Submission Details - K933968

510(k) Number K933968 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 1993
Decision Date June 16, 1994
Days to Decision 304 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
182d slower than avg
Panel avg: 122d · This submission: 304d
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 49
Devices cleared under the same product code (JEC) and FDA review panel - the closest regulatory comparables to K933968.
HOFFMANN II EXTERNAL FIXATION SYSTEM
K952730 · Howmedica Corp. · Sep 1995
ADDITIONAL ACCESSORIES FOR THE ORTHOFIX SYSTEM
K944092 · Orthofix Srl · Apr 1995
EXTERNAL FIXATOR
K943857 · Acu Med, Inc. · Jan 1995
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