Cleared Traditional

K032634 - NORMED COMPRESSION BONE SCREW SYSTEM

K032634 is an FDA 510(k) clearance for NORMED COMPRESSION BONE SCREW SYSTEM, manufactured by Noviace Corporation. The device is a Class 2 Orthopedic device with product code JDS cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K032634 · Noviace Corporation · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2003
Decision
41d
Days
Class 2
Risk

K032634 is an FDA 510(k) clearance for the NORMED COMPRESSION BONE SCREW SYSTEM. Classified as Nail, Fixation, Bone (product code JDS), Class II - Special Controls.

Submitted by Noviace Corporation (Paramus, US). The FDA issued a Cleared decision on October 6, 2003 after a review of 41 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - 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 Noviace Corporation devices

FDA 510(k) Submission Details - K032634

510(k) Number K032634 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 2003
Decision Date October 06, 2003
Days to Decision 41 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
81d faster than avg
Panel avg: 122d · This submission: 41d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JDS Device Classification - Class 2, Special Controls

Product Code JDS Nail, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
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 - JDS Nail, Fixation, Bone

All 41
Devices cleared under the same product code (JDS) and FDA review panel - the closest regulatory comparables to K032634.
SYNTHES (USA) TIBIAL NAIL SYSTEM EX
K040762 · Synthes (Usa) · Apr 2004
TRIGEN INTERTAN
K040212 · Smith & Nephew, Inc. · Feb 2004
SYNTHES (USA) CANNULATED TITANIUM HUMERAL NAIL SYSTEM
K033071 · Synthes (Usa) · Nov 2003
BNF
K021782 · Aap Implantate AG · Aug 2002
SYNTHES PROXIMAL HUMERAL NAIL
K002729 · Synthes (Usa) · Oct 2000
PEDIATRIC FIXATION RODS
K000764 · Biomet, Inc. · Apr 2000