Cleared Traditional

K802462 - SYNTHES SPINAL IMPLANT SYSTEM

K802462 is the FDA 510(k) clearance for SYNTHES SPINAL IMPLANT SYSTEM by Synthes (Usa). It is a Class 2 Orthopedic device (product code KWP) cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K802462 · Synthes (Usa) · Orthopedic device
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Dec 1980
Decision
69d
Days
Class 2
Risk

K802462 is an FDA 510(k) clearance for the SYNTHES SPINAL IMPLANT SYSTEM. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by Synthes (Usa) (Walker, US). The FDA issued a Cleared decision on December 16, 1980 after a review of 69 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 Synthes (Usa) devices

Submission Details

510(k) Number K802462 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 08, 1980
Decision Date December 16, 1980
Days to Decision 69 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
53d faster than avg
Panel avg: 122d · This submission: 69d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 270
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K802462.
EDWARDS SACRAL SCREW
K851935 · Zimmer, Inc. · Jun 1985
DEPUY SEGMENTALSPINAL SYSTEM
K810329 · Depuy, Inc. · Apr 1981
ARMSTRONG SPINAL APPLIANCE
K810224 · Howmedica Corp. · Feb 1981
EDWARDS ROD SLEEVES
K801080 · Zimmer, Inc. · May 1980
DUNN ANTERIOR DISTRACTION SYSTEM
K801120 · Zimmer, Inc. · May 1980
SANTA CASA DISTRACTOR
K791009 · Depuy, Inc. · Jun 1979