Cleared Traditional

K894098 - SYNTHES EXTERNAL FIXATION BONE CLIP

K894098 is the FDA 510(k) clearance for SYNTHES EXTERNAL FIXATION BONE CLIP by Synthes (Usa). It is a Class 2 Orthopedic device (product code JEC) cleared through the Traditional 510(k) pathway after a 325-day FDA review.

K894098 · Synthes (Usa) · Orthopedic device
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Apr 1990
Decision
325d
Days
Class 2
Risk

K894098 is an FDA 510(k) clearance for the SYNTHES EXTERNAL FIXATION BONE CLIP. Classified as Component, Traction, Invasive (product code JEC), Class II - Special Controls.

Submitted by Synthes (Usa) (Paoli, US). The FDA issued a Cleared decision on April 30, 1990 after a review of 325 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 Synthes (Usa) devices

Submission Details

510(k) Number K894098 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 1989
Decision Date April 30, 1990
Days to Decision 325 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
203d slower than avg
Panel avg: 122d · This submission: 325d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 43
Devices cleared under the same product code (JEC) and FDA review panel - the closest regulatory comparables to K894098.
HOWMEDICA MONOTUBE T-CONNECTOR
K936124 · Howmedica, Inc. · Feb 1994
OLIVE K-WIRES
K903105 · Danek Medical, Inc. · Sep 1990
ACE WIRE TENSION CLAMP
K901984 · Buckman Co., Inc. · Jun 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