Cleared Traditional

K930153 - SYSTEM III HALO RING

K930153 is an FDA 510(k) clearance for SYSTEM III HALO RING, manufactured by Jerome Medical. The device is a Class 2 Orthopedic device with product code JEC cleared through the Traditional 510(k) pathway after a 206-day FDA review.

K930153 · Jerome Medical · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1993
Decision
206d
Days
Class 2
Risk

K930153 is an FDA 510(k) clearance for the SYSTEM III HALO RING. Classified as Component, Traction, Invasive (product code JEC), Class II - Special Controls.

Submitted by Jerome Medical (Mt Laurel, US). The FDA issued a Cleared decision on August 6, 1993 after a review of 206 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 Jerome Medical devices

FDA 510(k) Submission Details - K930153

510(k) Number K930153 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 12, 1993
Decision Date August 06, 1993
Days to Decision 206 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
84d slower than avg
Panel avg: 122d · This submission: 206d
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 53
Devices cleared under the same product code (JEC) and FDA review panel - the closest regulatory comparables to K930153.
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
OLIVE K-WIRES
K903105 · Danek Medical, Inc. · Sep 1990