Cleared Traditional

K911663 - CROSSLINK SYSTEM

K911663 is an FDA 510(k) clearance for CROSSLINK SYSTEM, manufactured by Synthes (Usa). The device is a Class 2 Orthopedic device with product code KWP cleared through the Traditional 510(k) pathway after a 346-day FDA review.

K911663 · Synthes (Usa) · Orthopedic device
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Mar 1992
Decision
346d
Days
Class 2
Risk

K911663 is an FDA 510(k) clearance for the CROSSLINK SYSTEM. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by Synthes (Usa) (Paoli, US). The FDA issued a Cleared decision on March 23, 1992 after a review of 346 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3050 - 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 - K911663

510(k) Number K911663 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 12, 1991
Decision Date March 23, 1992
Days to Decision 346 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
224d slower than avg
Panel avg: 122d · This submission: 346d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KWP Device Classification - Class 2, Special Controls

Product Code KWP Appliance, Fixation, Spinal Interlaminal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3050
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 - KWP Appliance, Fixation, Spinal Interlaminal

All 376
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K911663.
MCAFEE SPINAL SYSTEM FOR POSTERIOR APPLICATIONS
K912837 · Kirschner Medical Corp. · Aug 1992
TSRH(TM) LATERAL OFFSET PLATE
K914306 · Sofamor Danek Mfg., Inc. · Jun 1992
TSRH CENTRAL POST HOOKS
K914966 · Sofamor Danek Mfg., Inc. · May 1992
TSRH VARIABLE ANGLE SACRAL SCREW
K904243 · Danek Medical, Inc. · Jan 1992
LUQUE SEGMENTAL SPINAL INSTRUMENTATION
K913561 · Zimmer, Inc. · Jan 1992
RAY SACRAL FIXATION SYSTEM
K904520 · Danek Medical, Inc. · Oct 1991