Cleared Traditional

K943985 - LIMITED REUSE BLADES

K943985 is an FDA 510(k) clearance for LIMITED REUSE BLADES, manufactured by Linvatec Corp.. The device is a Class 2 Orthopedic device with product code HRX cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K943985 · Linvatec Corp. · Orthopedic device
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Nov 1994
Decision
83d
Days
Class 2
Risk

K943985 is an FDA 510(k) clearance for the LIMITED REUSE BLADES. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Linvatec Corp. (Largo, US). The FDA issued a Cleared decision on November 7, 1994 after a review of 83 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.

FDA 510(k) Submission Details - K943985

510(k) Number K943985 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 1994
Decision Date November 07, 1994
Days to Decision 83 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 122d · This submission: 83d
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 684
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K943985.
ENVISION ARTHROSCOPY VISUALIZATION SYSTEM
K943666 · Envision Surgical System, Inc. · Nov 1994
SE5 ARTHROSCOPY SYTEM
K941333 · Stryker Endoscopy · Nov 1994
ENVISION ARTHROSCOPY SYSTEM
K942081 · Envision Surgical System, Inc. · Nov 1994
ENDOSCOPIC PLANTAR FASCIA KIT
K940847 · Citation Medical Corp. · Oct 1994
GALILEO ARTHROSCOPES
K934707 · Galileo Electro-Optics Corp. · Oct 1994
3M FLUID IRRIGATION SYSTEM
K941388 · 3M Healthcare · Oct 1994
K943985 · LIMITED REUSE BLADES
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