Cleared Traditional

K925160 - ARTHRO FMS 4

K925160 is an FDA 510(k) clearance for ARTHRO FMS 4, manufactured by Orthoconcept, Inc.. The device is a Class 2 Orthopedic device with product code HRX cleared through the Traditional 510(k) pathway after a 492-day FDA review.

K925160 · Orthoconcept, Inc. · Orthopedic device
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Feb 1994
Decision
492d
Days
Class 2
Risk

K925160 is an FDA 510(k) clearance for the ARTHRO FMS 4. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Orthoconcept, Inc. (New York City, US). The FDA issued a Cleared decision on February 17, 1994 after a review of 492 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 Orthoconcept, Inc. devices

FDA 510(k) Submission Details - K925160

510(k) Number K925160 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 13, 1992
Decision Date February 17, 1994
Days to Decision 492 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
370d slower than avg
Panel avg: 122d · This submission: 492d
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 394
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K925160.
ACUFEX METAL ACL CANNULA
K932718 · Acufex Microsurgical, Inc. · Mar 1994
DISPOSABLE ARTHROSCOPIC ACCESSORY
K933949 · United States Surgical, A Division of Tyco Healthc · Mar 1994
ARTHREX TIBIAL TUNNEL CANNULA
K930152 · Arthrex, Inc. · Mar 1994
ACUFEX ARTHROSCOPE
K934270 · Acufex Microsurgical, Inc. · Feb 1994
ARTHREX INSTRUMENTS ( HIP )
K926212 · Arthrex, Inc. · Jan 1994
ARTHREX INSTRUMENTS (WRIST)
K926303 · Arthrex, Inc. · Jan 1994