Cleared Traditional

K894098 - SYNTHES EXTERNAL FIXATION BONE CLIP

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

K894098 · Synthes (Usa) · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K894098

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.

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 K894098.
CYPRESS CERVICAL TRACTION EQUIPMENT, CYPRESS HALO
K894959 · Alphatec Mfg., Inc. · Sep 1990
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