Cleared Traditional

K810329 - DEPUY SEGMENTALSPINAL SYSTEM

K810329 is an FDA 510(k) clearance for DEPUY SEGMENTALSPINAL SYSTEM, manufactured by Depuy, Inc.. The device is a Class 2 Orthopedic device with product code KWP cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K810329 · Depuy, Inc. · Orthopedic device
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Apr 1981
Decision
58d
Days
Class 2
Risk

K810329 is an FDA 510(k) clearance for the DEPUY SEGMENTALSPINAL SYSTEM. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by Depuy, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 8, 1981 after a review of 58 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 Depuy, Inc. devices

FDA 510(k) Submission Details - K810329

510(k) Number K810329 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 09, 1981
Decision Date April 08, 1981
Days to Decision 58 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
64d faster than avg
Panel avg: 122d · This submission: 58d
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 385
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K810329.
KIRSCHNER SPINAL PRODUCT SYSTEM
K854524 · Kirschner Medical Corp. · Dec 1985
EDWARDS SACRAL SCREW
K851935 · Zimmer, Inc. · Jun 1985
HARRINGTON-TYPE INSTRU-SCOLIOSIS
K840423 · Link America, Inc. · Mar 1984
ARMSTRONG SPINAL APPLIANCE
K810224 · Howmedica Corp. · Feb 1981
SYNTHES SPINAL IMPLANT SYSTEM
K802462 · Synthes (Usa) · Dec 1980
EDWARDS ROD SLEEVES
K801080 · Zimmer, Inc. · May 1980