Cleared Traditional

WishBone Medical Plate and Screw System (K180736) - FDA 510(k) Clearance

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

K180736 · Wishbone Medical, Inc. · Orthopedic device
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Oct 2018
Decision
196d
Days
Class 2
Risk

K180736 is an FDA 510(k) clearance for the WishBone Medical Plate and Screw System. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Wishbone Medical, Inc. (Warsaw, US). The FDA issued a Cleared decision on October 4, 2018 after a review of 196 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - 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 Wishbone Medical, Inc. devices

Submission Details

510(k) Number K180736 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 2018
Decision Date October 04, 2018
Days to Decision 196 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
74d slower than avg
Panel avg: 122d · This submission: 196d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HRS Plate, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
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 - HRS Plate, Fixation, Bone

All 700
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K180736.
Piccolo Composite® Plate System
K182015 · CarboFix Orthopedics , Ltd. · Oct 2018
Geminus Volar Distal Radius Plate System
K182492 · Skeletal Dynamics, LLC · Oct 2018
ORTHOLOC SPS Shoulder Plating System
K181587 · Tornier, Inc. · Oct 2018
ARIX Clavicle System
K180972 · Jeil Medical Corporation · Oct 2018
CoLink View Plating System
K182402 · In2bones USA, LLC · Sep 2018
Tandry Locking Plate System
K171904 · Microware Precision Co., Ltd. · Sep 2018