Cleared Traditional

K884798 - AME PINSITE SHIELD(TM)

K884798 is an FDA 510(k) clearance for AME PINSITE SHIELD(TM), manufactured by American Medical Electronics, Inc.. The device is a Class 2 Orthopedic device with product code JEC cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K884798 · American Medical Electronics, Inc. · Orthopedic device
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Feb 1989
Decision
86d
Days
Class 2
Risk

K884798 is an FDA 510(k) clearance for the AME PINSITE SHIELD(TM). Classified as Component, Traction, Invasive (product code JEC), Class II - Special Controls.

Submitted by American Medical Electronics, Inc. (Dallas, US). The FDA issued a Cleared decision on February 10, 1989 after a review of 86 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 American Medical Electronics, Inc. devices

FDA 510(k) Submission Details - K884798

510(k) Number K884798 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 1988
Decision Date February 10, 1989
Days to Decision 86 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 122d · This submission: 86d
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 57
Devices cleared under the same product code (JEC) and FDA review panel - the closest regulatory comparables to K884798.
ACE WIRE TENSION CLAMP
K901984 · Buckman Co., Inc. · Jun 1990
SYNTHES EXTERNAL FIXATION BONE CLIP
K894098 · Synthes (Usa) · Apr 1990
ACE WIRE TENSION CLAMP
K894982 · Buckman Co., Inc. · Jan 1990
KIRSCHNER SUPER-FIXATION SYSTEM
K881896 · Kirschner Medical Corp. · Jul 1988
EXTERNAL FIXATION SYSTEM(CAT. # SERIAS 5129)
K852397 · Howmedica Corp. · Aug 1985
SABA-COOMBS MINI EXTERNAL FIXATOR
K842343 · Zimmer, Inc. · Sep 1984