Cleared Traditional

K914282 - NUCLEOTOME(R) II (VERSION2) TISSUE ASPIRA/CUTTER

K914282 is an FDA 510(k) clearance for NUCLEOTOME II (VERSION2) TISSUE ASPIRA/..., 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 86-day FDA review.

K914282 · Surgical Dynamics, Inc. · Orthopedic device
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Dec 1991
Decision
86d
Days
Class 2
Risk

K914282 is an FDA 510(k) clearance for the NUCLEOTOME(R) II (VERSION2) TISSUE ASPIRA/CUTTER. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Surgical Dynamics, Inc. (Alameda, US). The FDA issued a Cleared decision on December 19, 1991 after a review of 86 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Surgical Dynamics, Inc. devices

FDA 510(k) Submission Details - K914282

510(k) Number K914282 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 1991
Decision Date December 19, 1991
Days to Decision 86 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
36d faster than avg
Panel avg: 122d · This submission: 86d
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 K914282.
SUCTION CONTROL FOOTSWITCH WITH SPEED CONTROL
K913401 · Smith & Nephew Dyonics, Inc. · Mar 1992
SMALL JOINT SYSTEM
K914559 · Smith & Nephew Dyonics, Inc. · Feb 1992
DANEK SPINALSCOPE
K901692 · Danek Medical, Inc. · Feb 1992
3M FLUID CONTROL SYSTEM SMALL JOINT COPS CANNULA
K912099 · 3M Company · Dec 1991
ARTHRO-FLOW IRRIGATION 2 SYSTEM
K913028 · Davol, Inc. · Oct 1991
CONCEPT MICROMILL
K912957 · Concept, Inc. · Oct 1991