Cleared Traditional

CastleLoc-S Posterior Cervical Fixation System (K162136) - FDA 510(k) Clearance

Also marketed or referenced as:
LnK Posterior Cervical Fixation System

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K162136 · L & K Biomed Co., Ltd. · Orthopedic device
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Nov 2016
Decision
94d
Days
Class 2
Risk

K162136 is an FDA 510(k) clearance for the CastleLoc-S Posterior Cervical Fixation System. Classified as Posterior Cervical Screw System (product code NKG), Class II - Special Controls.

Submitted by L & K Biomed Co., Ltd. (Giheung-Gu, Yongin-Si, KR). The FDA issued a Cleared decision on November 3, 2016 after a review of 94 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3075 - 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 L & K Biomed Co., Ltd. devices

Submission Details

510(k) Number K162136 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 2016
Decision Date November 03, 2016
Days to Decision 94 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
28d faster than avg
Panel avg: 122d · This submission: 94d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NKG Posterior Cervical Screw System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3075
Definition Posterior Cervical Screw Systems Are Intended For Use In Fusion Procedures Of The Cervical Spine And/or Craniocervical Junction And/or Cervicothoracic Junction For: 1) Spinal Fractures And Dislocations; 2) Deformities; 3) Instabilities; 4) Failed Previous Fusions; 5) Tumors; 6) Inflammatory Disorders; 7) Spinal Degeneration, 8) Facet Degeneration With Instability; And 9) Reconstruction Following Decompression To Treat Radiculopathy And/or Myelopathy. These Systems Are Also Intended To Stabilize The Spine In The Absence Of Fusion For A Limited Time Period In Patients With Tumors Involving The Cervical Spine In Whom Life Expectancy Is Of Insufficient Duration To Permit Achievement Of 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 - NKG Posterior Cervical Screw System

All 76
Devices cleared under the same product code (NKG) and FDA review panel - the closest regulatory comparables to K162136.
M.U.S.T. MINI Posterior Cervical Screws System
K171369 · Medacta International S.A. · Aug 2017
The Solstice OCT System
K170804 · Life Spine, Inc. · May 2017
The Cranial Fusion System
K162266 · Life Spine, Inc. · May 2017
Gibralt® Spine System and Gibralt® Occipital Spine System
K160697 · Exactech, Inc. · Jun 2016