Cleared Traditional

K001653 - XIA SPINE SYSTEM SACRAL BLOCK ASSEMBLY

K001653 is the FDA 510(k) clearance for XIA SPINE SYSTEM SACRAL BLOCK ASSEMBLY by Howmedica Osteonics Corp.. It is a Class 2 Orthopedic device (product code KWP) cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K001653 · Howmedica Osteonics Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2000
Decision
80d
Days
Class 2
Risk

K001653 is an FDA 510(k) clearance for the XIA SPINE SYSTEM SACRAL BLOCK ASSEMBLY. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by Howmedica Osteonics Corp. (Allendale, US). The FDA issued a Cleared decision on August 18, 2000 after a review of 80 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 Howmedica Osteonics Corp. devices

Submission Details

510(k) Number K001653 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 2000
Decision Date August 18, 2000
Days to Decision 80 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
42d faster than avg
Panel avg: 122d · This submission: 80d
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 271
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K001653.
XIA SPINE SYSTEM
K002505 · Howmedica Osteonics Corp. · Oct 2000
USS VAS
K002517 · Synthes (Usa) · Sep 2000
MOSS MIAMI 6.35MM ROD SYSTEM MONOAXIAL SCREWS, POLYAXIAL REDUCTION SCREWS AND SACRAL EXTENDERS
K002607 · Depuyacromed · Sep 2000
E-Z LINK CROSS CONNECTOR
K001470 · Depuyacromed · Aug 2000
E-Z LINK CROSS CONNECTOR
K001372 · Depuyacromed · Jul 2000
SPINE SYSTEM EVOLUTION
K001080 · Aesculap, Inc. · Jun 2000