Cleared Special

K171327 - Tyber Medical Wedge System

K171327 is an FDA 510(k) clearance for Tyber Medical Wedge System, manufactured by Tyber Medical, LLC. The device is a Class 2 Orthopedic device with product code PLF cleared through the Special 510(k) pathway after a 11-day FDA review.

K171327 · Tyber Medical, LLC · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2017
Decision
11d
Days
Class 2
Risk

K171327 is an FDA 510(k) clearance for the Tyber Medical Wedge System. Classified as Bone Wedge (product code PLF), Class II - Special Controls.

Submitted by Tyber Medical, LLC (Bethlehem, US). The FDA issued a Cleared decision on May 16, 2017 after a review of 11 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K171327

510(k) Number K171327 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 05, 2017
Decision Date May 16, 2017
Days to Decision 11 days
Submission Type Special
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
111d faster than avg
Panel avg: 122d · This submission: 11d
Pathway characteristics
Modification to existing cleared device.

PLF Device Classification - Class 2, Special Controls

Product Code PLF Bone Wedge
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
Definition Intended To Be Used With Ancillary Fixation For Opening Wedge Osteotomies Or Fusion In The Ankle, Foot, Proximal Tibia.
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 - PLF Bone Wedge

All 17
Devices cleared under the same product code (PLF) and FDA review panel - the closest regulatory comparables to K171327.
Trigon HA Stand-Alone Wedge Fixation System
K193414 · Nvision Biomedical Technologies, Inc. · Feb 2020
Trigon™ Ti Stand-Alone Wedge Fixation System
K192645 · Nvision Biomedical Technologies, Inc. · Dec 2019
ADI TiDAL Osteotomy Wedge
K191047 · Additive Device, Inc. (Adi) D/B/A Restor3D · Nov 2019
TITAN 3-D™ Wedge System
K162241 · Paragon 28 · Apr 2017
Arthrex BioSync® Bone Wedge
K151256 · Arthex, Inc. · Aug 2015
Tyber Medical Wedge System
K150394 · Tyber Medical, LLC · Jul 2015
K171327 · Tyber Medical Wedge System
Download PDF FDA Summary Tyber Medical, LLC