Cleared Traditional

K943985 - LIMITED REUSE BLADES

K943985 is the FDA 510(k) clearance for LIMITED REUSE BLADES by Linvatec Corp.. It is a Class 2 Orthopedic device (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.

View all Linvatec Corp. devices

Submission Details

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.

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 K943985.
MENISCAL SUTURE INSTRUMENTARIUM
K940287 · Richard Wolf Medical Instruments Corp. · Nov 1994
DANEKSCOPE OPTI-PROBE
K943676 · Danek Medical, Inc. · Nov 1994
SE5 ARTHROSCOPY SYTEM
K941333 · Stryker Endoscopy · Nov 1994
ACUFEX ACL SHEATH FOR INTERFERENCE SCREWS
K940290 · Acufex Microsurgical, Inc. · Sep 1994
CURVED ROTATABLE DISPOSABLE ARTHROSCOPIC SURGERY BLADES
K941036 · Smith & Nephew, Inc. · Sep 1994
MANUAL SURGICAL INSTRUMENTS
K942079 · Acufex Microsurgical, Inc. · Sep 1994