Cleared Traditional

K152781 - Adena-Zina System

K152781 is an FDA 510(k) clearance for Adena-Zina System, manufactured by Shanghai Sanyou Medical Co, Ltd.. The device is a Class 2 Orthopedic device with product code NKB cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K152781 · Shanghai Sanyou Medical Co, Ltd. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2016
Decision
140d
Days
Class 2
Risk

K152781 is an FDA 510(k) clearance for the Adena-Zina System. Classified as Thoracolumbosacral Pedicle Screw System within the NKB classification (a category for thoracolumbosacral pedicle screw systems), Class II - Special Controls.

Submitted by Shanghai Sanyou Medical Co, Ltd. (Jiading District, CN). The FDA issued a Cleared decision on February 12, 2016 after a review of 140 days - within the typical 510(k) review window.

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 Shanghai Sanyou Medical Co, Ltd. devices

FDA 510(k) Submission Details - K152781

510(k) Number K152781 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 2015
Decision Date February 12, 2016
Days to Decision 140 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
18d slower than avg
Panel avg: 122d · This submission: 140d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NKB Device Classification - Class 2, Special Controls

Product Code NKB Thoracolumbosacral Pedicle Screw System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3070
Definition Intended To Provide Immobilization And Stabilization Of Spinal Segments In Thoracic, Lumbar, And Sacral Spine As An Adjunct To Fusion.
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 - NKB Thoracolumbosacral Pedicle Screw System

All 707
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K152781.
Response 5.5 Spine System
K160466 · OrthoPediatrics Corp. · Mar 2016
Palisade Pedicular Fixation System
K153323 · Spineology, Inc. · Feb 2016
CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with the STEALTHSTATION System, Medtronic Reusable Instruments for Use with the IPC POWEREASE System, Medtronic Navigated Reusable Instruments for Use with the STEALTHSTATION and IPC POWEREASE Systems
K153442 · Medtronic Sofamor Danek USA, Inc. · Feb 2016
CD HORIZON Spinal System
K153589 · Medtronic Sofamor Danek USA, Inc. · Feb 2016
Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System
K153428 · Orthofix, Inc. · Jan 2016
M.U.S.T. Pedicle Screw System
K153664 · Medacta International · Jan 2016