Cleared Traditional

ARMSTRONG SPINAL APPLIANCE (K810224) - FDA 510(k) Clearance

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

K810224 · Howmedica Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1981
Decision
14d
Days
Class 2
Risk

K810224 is an FDA 510(k) clearance for the ARMSTRONG SPINAL APPLIANCE. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by Howmedica Corp. (Walker, US). The FDA issued a Cleared decision on February 10, 1981 after a review of 14 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 Corp. devices

Submission Details

510(k) Number K810224 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 1981
Decision Date February 10, 1981
Days to Decision 14 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
108d faster than avg
Panel avg: 122d · This submission: 14d
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 429
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K810224.
SYNAPSE SYSTEM 4.0MM, OC FUSION SYSTEM 4.0MM
K091689 · Synthes (Usa) · Jul 2009
SYNTHES PANGEA SYSTEM
K052123 · Synthes (Usa) · Sep 2005
CLICK'X MONOAXIAL SCREWS AND HOOKS
K031175 · Synthes (Usa) · Nov 2003
XIA SPINAL SYSTEM AND XIA STAINLESS STEEL SYSTEM
K031893 · Howmedica Osteonics Corp. · Jul 2003
MODIFICATION TO XIA STAINLESS STEEL SYSTEM
K031090 · Howmedica Osteonics Corp. · Apr 2003
SYNTHES CERVIFIX/ AXON
K023675 · Synthes (Usa) · Nov 2002