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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
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.

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
Combination Product No
PCCP Authorized No
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 21
Devices cleared under the same product code (NQP) and FDA review panel - the closest regulatory comparables to K072321.
DDS STABILIZATION SYSTEM
K080241 · Paradigm Spine, LLC · Nov 2008
DSS STABILIZATION SYSTEM
K080963 · Paradigm Spine · May 2008
ISOBAR SEMI-RIGID DUAL DAMPENER
K071261 · Scient'X · Apr 2008
DYNESYS TOP-LOADING SPINAL SYSTEM
K073347 · Zimmer Spine, Inc. · Feb 2008
DSS
K072969 · Paradigm Spine, LLC · Jan 2008
NGARDE SYSTEM
K072685 · N-Spine, Inc. · Oct 2007
K072321 · BIOFLEX
Download PDF FDA Summary Biospine Co., Ltd.