Cleared Traditional

K010115 - REFLEX ANTERIOR CERVICAL PLATE SYSTEM

K010115 is an FDA 510(k) clearance for REFLEX ANTERIOR CERVICAL PLATE SYSTEM, manufactured by Howmedica Osteonics Corp.. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K010115 · Howmedica Osteonics Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2001
Decision
90d
Days
Class 2
Risk

K010115 is an FDA 510(k) clearance for the REFLEX ANTERIOR CERVICAL PLATE SYSTEM. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Howmedica Osteonics Corp. (Allendale, US). The FDA issued a Cleared decision on April 16, 2001 after a review of 90 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Howmedica Osteonics Corp. devices

FDA 510(k) Submission Details - K010115

510(k) Number K010115 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 2001
Decision Date April 16, 2001
Days to Decision 90 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
32d faster than avg
Panel avg: 122d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KWQ Device Classification - Class 2, Special Controls

Product Code KWQ Appliance, Fixation, Spinal Intervertebral Body
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 - KWQ Appliance, Fixation, Spinal Intervertebral Body

All 592
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K010115.
MACS HMA ANTERIOR SPINAL STABILIZATION SYSTEM
K011556 · Aesculap, Inc. · Nov 2001
MACROPORE OS SPINAL SYSTEM
K010911 · Macropore Biosurgery, Inc. · Jul 2001
MACS MODULAR ANTERIOR CONSTRUCT SYSTEM
K002824 · Aesculap, Inc. · May 2001
EBI VUELOCK ANTERIOR CERVICAL PLATE SYSTEM
K010003 · Ebi, L.P. · Jan 2001
MODIFICATION TO EBI ANTERIOR CERVICAL PLATE SYSTEM
K002980 · Ebi, L.P. · Oct 2000
XIA SPINE SYSTEM
K002858 · Howmedica Osteonics Corp. · Oct 2000