Cleared Traditional

K163011 - PHA S1 Spinal System

K163011 is an FDA 510(k) clearance for PHA S1 Spinal System, manufactured by Phamedica, Inc.. The device is a Class 2 Orthopedic device with product code NKB cleared through the Traditional 510(k) pathway after a 244-day FDA review.

K163011 · Phamedica, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2017
Decision
244d
Days
Class 2
Risk

K163011 is an FDA 510(k) clearance for the PHA S1 Spinal System. Classified as Thoracolumbosacral Pedicle Screw System within the NKB classification (a category for thoracolumbosacral pedicle screw systems), Class II - Special Controls.

Submitted by Phamedica, Inc. (Plainview, US). The FDA issued a Cleared decision on June 29, 2017 after a review of 244 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 - K163011

510(k) Number K163011 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 2016
Decision Date June 29, 2017
Days to Decision 244 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
122d slower than avg
Panel avg: 122d · This submission: 244d
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 Consultant

Empirical Consulting, LLC
Kenneth C. Maxwell II

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - NKB Thoracolumbosacral Pedicle Screw System

All 913
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K163011.
True Spinal Fixation System
K170710 · Innovative Surgical Designs, Inc. · Jul 2017
Vitality® Spinal Fixation System
K171907 · Zimmer Biomet Spine, Inc. · Jul 2017
OpenLoc-L Spinal Fixation System, LnK Spinal Fixation System
K171813 · L & K Biomed Co., Ltd. · Jul 2017
Swedge™ Pedicle Screw Fixation System
K170045 · Spinal Resources, Inc. · Jun 2017
Iliad® Pedicle Screw System and Zenius® Pedicle Screw System
K171509 · Medyssey USA, Inc. · Jun 2017
ChoiceSpine™ Proliant® Posterior Pedicle Screw and Hook Fixation System
K170821 · Choicespine, LP · Jun 2017
K163011 · PHA S1 Spinal System
Download PDF FDA Summary Phamedica, Inc.