Cleared Traditional

K172185 - Tyber Medical PT Interbody Spacer System

K172185 is the FDA 510(k) clearance for Tyber Medical PT Interbody Spacer System by Tyber Medical, LLC. It is a Class 2 Orthopedic device (product code ODP) cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K172185 · Tyber Medical, LLC · Orthopedic device
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Dec 2017
Decision
154d
Days
Class 2
Risk

K172185 is an FDA 510(k) clearance for the Tyber Medical PT Interbody Spacer System. Classified as Intervertebral Fusion Device With Bone Graft, Cervical (product code ODP), Class II - Special Controls.

Submitted by Tyber Medical, LLC (Bethlehem, US). The FDA issued a Cleared decision on December 21, 2017 after a review of 154 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 Tyber Medical, LLC devices

Submission Details

510(k) Number K172185 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 2017
Decision Date December 21, 2017
Days to Decision 154 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
32d slower than avg
Panel avg: 122d · This submission: 154d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 223
Devices cleared under the same product code (ODP) and FDA review panel - the closest regulatory comparables to K172185.
Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TAS Hyperlordotic Interbody Fusion Device and Endoskeleton® TCS Interbody Fusion Device
K173535 · Titan Spine, LLC · Feb 2018
MATISSE Anterior Cervical Interbody Fusion Cage System, Ti-PEEK™
K172212 · Ctl Medical Corporation · Jan 2018
Cervical Spinal Truss System (CSTS) Interbody Fusion Device
K173159 · 4Web, Inc. · Jan 2018
SeaSpine Vu cPOD, Zuma-C, Complete Cervical
K172926 · SeaSpine Orthopedics Corporation · Dec 2017
COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and COALITION AGX® TPS
K173115 · Globus Medical, Inc. · Dec 2017
NuVasive® Modulus-C Interbody System
K172676 · Nu Vasive, Incorporated · Dec 2017