Cleared Traditional

Articulator Arthroscopic Bur

K252666 · Joint Preservation Innovations, LLC · Orthopedic

Nov 2025

Decision

88d

Days

Class 2

Risk

About This 510(k) Submission

K252666 is an FDA 510(k) clearance for the Articulator Arthroscopic Bur, a Arthroscope (Class II — Special Controls, product code HRX), submitted by Joint Preservation Innovations, LLC (Naperville, US). The FDA issued a Cleared decision on November 21, 2025, 88 days after receiving the submission on August 25, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.1100.

Submission Details

510(k) Number	K252666 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 25, 2025
Decision Date	November 21, 2025
Days to Decision	88 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	HRX — Arthroscope
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.1100
Definition	Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).