Cleared Traditional

K170703 - Single Use Arthroscopic Electrode (with...

K170703 is an FDA 510(k) clearance for Single Use Arthroscopic Electrode (with..., manufactured by Modern Medical Equipment Manufacturing Limited. The device is a Class 2 Orthopedic device with product code HRX cleared through the Traditional 510(k) pathway after a 449-day FDA review.

K170703 · Modern Medical Equipment Manufacturing Limited · Orthopedic device
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May 2018
Decision
449d
Days
Class 2
Risk

K170703 is an FDA 510(k) clearance for the Single Use Arthroscopic Electrode (with Pencil). Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Modern Medical Equipment Manufacturing Limited (Hong Kong, CN). The FDA issued a Cleared decision on May 31, 2018 after a review of 449 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Orthopedic submissions.

View all Modern Medical Equipment Manufacturing Limited devices

FDA 510(k) Submission Details - K170703

510(k) Number K170703 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 2017
Decision Date May 31, 2018
Days to Decision 449 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
327d slower than avg
Panel avg: 122d · This submission: 449d
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 413
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