Cleared Traditional

K002040 - FMS SOLO

K002040 is the FDA 510(k) clearance for FMS SOLO by Future Medical Systems, Inc.. It is a Class 2 Orthopedic device (product code HRX) cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K002040 · Future Medical Systems, Inc. · Orthopedic device
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Sep 2000
Decision
68d
Days
Class 2
Risk

K002040 is an FDA 510(k) clearance for the FMS SOLO. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Future Medical Systems, Inc. (Glen Burnie, US). The FDA issued a Cleared decision on September 11, 2000 after a review of 68 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 Future Medical Systems, Inc. devices

Submission Details

510(k) Number K002040 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 2000
Decision Date September 11, 2000
Days to Decision 68 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
54d faster than avg
Panel avg: 122d · This submission: 68d
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 361
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K002040.
METRX SYSTEM
K002931 · Medtronic Sofamor Danek, Inc. · Nov 2000
RADIONICS RF DISC CATHETER ELECTRODE SYSTEM
K001741 · Radionics, Inc. · Oct 2000
KSEA PERCUTANEOUS FORAMINOSCOPY SET
K001918 · KARL STORZ Endoscopy-America, Inc. · Sep 2000
SURGICAL DYNAMICS SPINAL RETRACTOR
K002008 · United States Surgical, A Division of Tyco Healthc · Aug 2000
SMITH + NEPHEW RF ARTHROSCOPIC WAND SYSTEM
K001226 · Smith & Nephew, Inc. · Jun 2000
KNIGHT ENDOSCOPIC SPINE SYSTEM (KESS)
K000046 · Richard Wolf Medical Instruments Corp. · Mar 2000