Cleared Traditional

K903105 - OLIVE K-WIRES

K903105 is an FDA 510(k) clearance for OLIVE K-WIRES, manufactured by Danek Medical, Inc.. The device is a Class 2 Orthopedic device with product code JEC cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K903105 · Danek Medical, Inc. · Orthopedic device
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Sep 1990
Decision
63d
Days
Class 2
Risk

K903105 is an FDA 510(k) clearance for the OLIVE K-WIRES. Classified as Component, Traction, Invasive (product code JEC), Class II - Special Controls.

Submitted by Danek Medical, Inc. (Memphis, US). The FDA issued a Cleared decision on September 6, 1990 after a review of 63 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 Danek Medical, Inc. devices

FDA 510(k) Submission Details - K903105

510(k) Number K903105 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 1990
Decision Date September 06, 1990
Days to Decision 63 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
59d faster than avg
Panel avg: 122d · This submission: 63d
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 46
Devices cleared under the same product code (JEC) and FDA review panel - the closest regulatory comparables to K903105.
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 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