Cleared Traditional

K882877 - JMS CERVICAL TRACTION DEVICE/HALO DEVICE

K882877 is an FDA 510(k) clearance for JMS CERVICAL TRACTION DEVICE/HALO DEVICE, 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 81-day FDA review.

K882877 · Jerome Medical · Orthopedic device
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Sep 1988
Decision
81d
Days
Class 2
Risk

K882877 is an FDA 510(k) clearance for the JMS CERVICAL TRACTION DEVICE/HALO DEVICE. 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 September 30, 1988 after a review of 81 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.

FDA 510(k) Submission Details - K882877

510(k) Number K882877 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 1988
Decision Date September 30, 1988
Days to Decision 81 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 122d · This submission: 81d
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 74
Devices cleared under the same product code (JEC) and FDA review panel - the closest regulatory comparables to K882877.
TRACER DYNAMIC AXIAL FIXATION
K892638 · Tracer Medical · Aug 1989
AME PINSITE SHIELD(TM)
K884798 · American Medical Electronics, Inc. · Feb 1989
MODIFIED CHICK AMBULATORY HALO
K884242 · Chick Medical Products · Dec 1988
KIRSCHNER SUPER-FIXATION SYSTEM
K881896 · Kirschner Medical Corp. · Jul 1988
LIMA-LTO ECS EXTERNAL CIRCULAR STABILIZER
K881673 · Lima-Lto, Inc. · Jun 1988
LIMA-LTO. SEM MODULAR EXTERNAL STABLIZER
K880282 · Lima-Lto, Inc. · Feb 1988
K882877 · JMS CERVICAL TRACTION DEVICE/HALO DEVICE
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