Cleared Traditional

SPINE SYSTEM EVOLUTION (K001080) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K001080 · Aesculap, Inc. · Orthopedic device
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Jun 2000
Decision
86d
Days
Class 2
Risk

K001080 is an FDA 510(k) clearance for the SPINE SYSTEM EVOLUTION. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by Aesculap, Inc. (South San Francisco, US). The FDA issued a Cleared decision on June 29, 2000 after a review of 86 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 Aesculap, Inc. devices

Submission Details

510(k) Number K001080 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 2000
Decision Date June 29, 2000
Days to Decision 86 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 122d · This submission: 86d
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 98
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K001080.
XIA SPINE SYSTEM
K002505 · Howmedica Osteonics Corp. · Oct 2000
USS VAS
K002517 · Synthes (Usa) · Sep 2000
XIA SPINE SYSTEM SACRAL BLOCK ASSEMBLY
K001653 · Howmedica Osteonics Corp. · Aug 2000
SYNTHES CERVIFIX SYSTEM
K994187 · Synthes (Usa) · Dec 1999
SYNTHES CERVIFIX SYSTEM
K990965 · Synthes (Usa) · Jul 1999
OSTEONICS SPINAL SYSTEM VERSATILE CROSS CONNECTOR
K990922 · Howmedica Osteonics Corp. · Jun 1999