Cleared Traditional

NUCLEOTOME E KIT (K931109) - FDA 510(k) Clearance

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

K931109 · Surgical Dynamics, Inc. · Orthopedic device
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Mar 1994
Decision
391d
Days
Class 2
Risk

K931109 is an FDA 510(k) clearance for the NUCLEOTOME E KIT. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Surgical Dynamics, Inc. (Alameda, US). The FDA issued a Cleared decision on March 29, 1994 after a review of 391 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 Surgical Dynamics, Inc. devices

Submission Details

510(k) Number K931109 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received March 03, 1993
Decision Date March 29, 1994
Days to Decision 391 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
269d slower than avg
Panel avg: 122d · This submission: 391d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 178
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K931109.
ARTHREX ARTHROSCOPE
K921119 · Arthrex, Inc. · Apr 1994
SHAVER BLADE SET
K940075 · Arthrex, Inc. · Apr 1994
MOD. PERCUTANEOUS ARTHROSCOPIC MICRO DISCECTOMY
K922519 · Smith & Nephew, Inc. · Mar 1994
AUTO SUTURE DISPOSABLE ARTHROSCOPIC TROCAR AND SLEEVE
K934720 · United States Surgical, A Division of Tyco Healthc · Mar 1994
ARTHTOTEK PRECISION HAND INSTRUMENTATION
K933070 · Biomet, Inc. · Mar 1994
ARTHROTEK CANNULA SYSTEM
K934401 · Biomet, Inc. · Mar 1994