Cleared Traditional

K020152 - SYNTHES VERTEBRAL SPACER TI

K020152 is the FDA 510(k) clearance for SYNTHES VERTEBRAL SPACER TI by Synthes (Usa). It is a Class 2 Orthopedic device (product code MQP) cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K020152 · Synthes (Usa) · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2002
Decision
89d
Days
Class 2
Risk

K020152 is an FDA 510(k) clearance for the SYNTHES VERTEBRAL SPACER TI. Classified as Spinal Vertebral Body Replacement Device (product code MQP), Class II - Special Controls.

Submitted by Synthes (Usa) (Paoli, US). The FDA issued a Cleared decision on April 16, 2002 after a review of 89 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3060 - 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 K020152 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 17, 2002
Decision Date April 16, 2002
Days to Decision 89 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
33d faster than avg
Panel avg: 122d · This submission: 89d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MQP Spinal Vertebral Body Replacement Device
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3060
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 - MQP Spinal Vertebral Body Replacement Device

All 158
Devices cleared under the same product code (MQP) and FDA review panel - the closest regulatory comparables to K020152.
VERTEBRAL SPACER
K011037 · Synthes (Usa) · Jul 2002
MODIFICATION TO HEDROCEL VERTEBRAL BODY REPLACEMENT, MODEL XX-YYY-ZZZZ
K021025 · Implex Corp. · May 2002
EBI AIS SPINE SYSTEM
K020887 · Ebi, L.P. · May 2002
MODIFICATION TO SURGICAL TITANIUM MESH SYSTEM
K020522 · Depuyacromed · Mar 2002
TELESCOPIC PLATE SPACER THORACOLUMBAR (TPS-TL) SPINAL SYSTEM, MODELS 8123, 8124, 8132, 8133, 8156, 8157, 8158, & 8189
K020204 · Interpore Cross Intl. · Feb 2002
MODIFICATION TO GEO STRUCTURE
K020048 · Interpore Cross Intl. · Feb 2002