Cleared Traditional

K163422 - Shanghai Sanyou PEEK Cage System

K163422 is an FDA 510(k) clearance for Shanghai Sanyou PEEK Cage System, manufactured by Shanghai Sanyou Medical Co, Ltd.. The device is a Class 2 Orthopedic device with product code ODP cleared through the Traditional 510(k) pathway after a 286-day FDA review.

K163422 · Shanghai Sanyou Medical Co, Ltd. · Orthopedic device
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Sep 2017
Decision
286d
Days
Class 2
Risk

K163422 is an FDA 510(k) clearance for the Shanghai Sanyou PEEK Cage System. Classified as Intervertebral Fusion Device With Bone Graft, Cervical (product code ODP), Class II - Special Controls.

Submitted by Shanghai Sanyou Medical Co, Ltd. (Jiading District, CN). The FDA issued a Cleared decision on September 18, 2017 after a review of 286 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3080 - 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 - K163422

510(k) Number K163422 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 2016
Decision Date September 18, 2017
Days to Decision 286 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
164d slower than avg
Panel avg: 122d · This submission: 286d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ODP Device Classification - Class 2, Special Controls

Product Code ODP Intervertebral Fusion Device With Bone Graft, Cervical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3080
Definition Intended To Stabilize Cervical Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft.
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 - ODP Intervertebral Fusion Device With Bone Graft, Cervical

All 243
Devices cleared under the same product code (ODP) and FDA review panel - the closest regulatory comparables to K163422.
Vertera Spine Cohere Cervical Interbody Fusion Device
K173030 · Nu Vasive, Incorporated · Nov 2017
CONSTRUX® Mini PTC Spacer System, FORZA® PTC Spacer System, PILLAR® SA PTC Spacer System
K172437 · Orthofix, Inc. · Nov 2017
SCARLET AC-T
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Mecta-C with titanium markers and Mecta-C TiPEEK with titanium markers
K172587 · Medacta International S.A. · Sep 2017
Reliance Cervical IBF System
K172489 · Reliance Medical Systems, LLC · Sep 2017
Tritanium C Anterior Cervical Cage
K171496 · Stryker Spine · Sep 2017