Cleared Traditional

K072321 - BIOFLEX

K072321 is an FDA 510(k) clearance for BIOFLEX, manufactured by Biospine Co., Ltd.. The device is a Class 2 Orthopedic device with product code NQP cleared through the Traditional 510(k) pathway after a 218-day FDA review.

K072321 · Biospine Co., Ltd. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Mar 2008
Decision
218d
Days
Class 2
Risk

K072321 is an FDA 510(k) clearance for the BIOFLEX. Classified as Posterior Metal/polymer Spinal System, Fusion (product code NQP), Class II - Special Controls.

Submitted by Biospine Co., Ltd. (Washington, US). The FDA issued a Cleared decision on March 25, 2008 after a review of 218 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3070 - 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 Biospine Co., Ltd. devices

FDA 510(k) Submission Details - K072321

510(k) Number K072321 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 2007
Decision Date March 25, 2008
Days to Decision 218 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
96d slower than avg
Panel avg: 122d · This submission: 218d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NQP Device Classification - Class 2, Special Controls

Product Code NQP Posterior Metal/polymer Spinal System, Fusion
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3070
Definition This Device Is A Posterior Spinal System That Contains Polymer And Metal Components. This Spinal System Is To Be Used With Bone Graft And Is An Adjunct To Fusion In The Treatment Of Acute And Chronic Instabilities Or Deformities Of The Thoracic, Lumbar, And Sacral Spine.
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 - NQP Posterior Metal/polymer Spinal System, Fusion

All 12
Devices cleared under the same product code (NQP) and FDA review panel - the closest regulatory comparables to K072321.
ZIMMER DTO PIN PRESS INSTRUMENT
K101704 · Zimmer Spine, Inc. · Aug 2010
DYNESYS TOP-LOADING SPINAL SYSTEM
K092234 · Zimmer Spine, Inc. · Oct 2009
TRANSITION STABILIZATION SYSTEM
K073439 · Globus Medical, Inc. · Feb 2009
DYNESYS TOP-LOADING SPINAL SYSTEM
K073347 · Zimmer Spine, Inc. · Feb 2008
ZIMMER DTO IMPLANT
K071879 · Zimmer Spine, Inc. · Oct 2007
CD HORIZON SPINAL SYSTEM
K061304 · Medtronic Sofamor Danek · Jul 2006