Cleared Traditional

K923525 - NUCLEOTOME 3.5 MM AUTOMATED PERCUTANEOUS LUMBAR

K923525 is an FDA 510(k) clearance for NUCLEOTOME 3.5 MM AUTOMATED PERCUTANEOU..., manufactured by Surgical Dynamics, Inc.. The device is a Class 2 Orthopedic device with product code HRX cleared through the Traditional 510(k) pathway after a 208-day FDA review.

K923525 · Surgical Dynamics, Inc. · Orthopedic device
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Feb 1993
Decision
208d
Days
Class 2
Risk

K923525 is an FDA 510(k) clearance for the NUCLEOTOME 3.5 MM AUTOMATED PERCUTANEOUS LUMBAR. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Surgical Dynamics, Inc. (Alameda, US). The FDA issued a Cleared decision on February 9, 1993 after a review of 208 days - an extended review cycle.

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. Standard predicate reliance. 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

FDA 510(k) Submission Details - K923525

510(k) Number K923525 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 1992
Decision Date February 09, 1993
Days to Decision 208 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
86d slower than avg
Panel avg: 122d · This submission: 208d
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 522
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K923525.
ARTHROSCOPIC ACL DRILL SYSTEM
K925986 · Arthrex, Inc. · Mar 1993
ARTHREX INSTRUMENTS (KNEE, GP 3)
K925995 · Arthrex, Inc. · Mar 1993
ARTHREX PLUS
K923142 · Arthrex, Inc. · Feb 1993
ARTHREX KNEE ARTHROSCOPIC SURGERY ACCESSORIES
K922890 · Arthrex, Inc. · Feb 1993
ARTHREX ATRAUMATIC MINI-GRASPER
K925455 · Arthrex, Inc. · Feb 1993
ARTHREX ARTHROSCOPY ICE BLADE
K921823 · Arthrex, Inc. · Oct 1992