Cleared Traditional

K241990 - SpineSite Endoscope System

K241990 is an FDA 510(k) clearance for SpineSite Endoscope System, manufactured by Hydrocision, Inc.. The device is a Class 2 Orthopedic device with product code HRX cleared through the Traditional 510(k) pathway after a 387-day FDA review.

K241990 · Hydrocision, Inc. · Orthopedic device
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Jul 2025
Decision
387d
Days
Class 2
Risk

K241990 is an FDA 510(k) clearance for the SpineSite Endoscope System. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Hydrocision, Inc. (North Billerica, US). The FDA issued a Cleared decision on July 30, 2025 after a review of 387 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.1100 - 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. Elevated predicate reliance profile. 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 Hydrocision, Inc. devices

FDA 510(k) Submission Details - K241990

510(k) Number K241990 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 2024
Decision Date July 30, 2025
Days to Decision 387 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
265d slower than avg
Panel avg: 122d · This submission: 387d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HRX Device Classification - Class 2, Special Controls

Product Code HRX Arthroscope
Device Class Class 2 - 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).
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 - HRX Arthroscope

All 411
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K241990.
TunnelVision Endoscopic Soft Tissue Release System and the HBL Blade Assembly
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K252594 · Sonex Health · Sep 2025
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K243774 · Lesspine Innovations · Aug 2025
Arthrex Spine Endoscope
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MIDASVu
K243020 · Intravu, Inc. · Dec 2024