Cleared Traditional

K920116 - PWB LUMBOSACRAL SPINE SYSTEM

K920116 is an FDA 510(k) clearance for PWB LUMBOSACRAL SPINE SYSTEM, manufactured by Cross Medical Products, Inc.. The device is a Class 2 Orthopedic device with product code KWP cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K920116 · Cross Medical Products, Inc. · Orthopedic device
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Apr 1992
Decision
88d
Days
Class 2
Risk

K920116 is an FDA 510(k) clearance for the PWB LUMBOSACRAL SPINE SYSTEM. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by Cross Medical Products, Inc. (Concord, US). The FDA issued a Cleared decision on April 10, 1992 after a review of 88 days - a notably fast clearance cycle.

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: 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 Cross Medical Products, Inc. devices

FDA 510(k) Submission Details - K920116

510(k) Number K920116 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received January 13, 1992
Decision Date April 10, 1992
Days to Decision 88 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
34d faster than avg
Panel avg: 122d · This submission: 88d
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 368
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K920116.
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
CROSSLINK SYSTEM
K911663 · Synthes (Usa) · Mar 1992
TSRH VARIABLE ANGLE SACRAL SCREW
K904243 · Danek Medical, Inc. · Jan 1992
LUQUE SEGMENTAL SPINAL INSTRUMENTATION
K913561 · Zimmer, Inc. · Jan 1992