Cleared Special

WishBone Medical Plate and Screw System (K230527) - FDA 510(k) Clearance

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K230527 · Wishbone Medical, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2023
Decision
30d
Days
Class 2
Risk

K230527 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 March 29, 2023 after a review of 30 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.

View all Wishbone Medical, Inc. devices

Submission Details

510(k) Number K230527 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 2023
Decision Date March 29, 2023
Days to Decision 30 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 122d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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 K230527.
MotoBAND™ CP Implant System: DynaBunion™ 4D Minimal-incision Bunion System, DynaMET™ Lesser TMT Fusion System
K223342 · Crossroads Extremity Systems, LLC · Mar 2023
Medartis APTUS® Ulna Plates
K223853 · Medartis AG · Mar 2023
KLS Martin Level One Rib Fixation System
K222397 · KLS-Martin L.P. · Mar 2023
KLS Martin Pure Pectus System
K221938 · KLS-Martin L.P. · Mar 2023
LOQTEQ® VA Elbow Plates 2.7/3.5 System
K230141 · Aap Implantate AG · Mar 2023
Tyber Medical Anatomical Plating System
K222465 · Tyber Medical, LLC · Mar 2023