Cleared Traditional

K940515 - POLY BLADES

K940515 is the FDA 510(k) clearance for POLY BLADES by Linvatec Corp.. It is a Class 2 Orthopedic device (product code HRX) cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K940515 · Linvatec Corp. · Orthopedic device
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May 1994
Decision
111d
Days
Class 2
Risk

K940515 is an FDA 510(k) clearance for the POLY BLADES. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Linvatec Corp. (Largo, US). The FDA issued a Cleared decision on May 26, 1994 after a review of 111 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Linvatec Corp. devices

Submission Details

510(k) Number K940515 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 1994
Decision Date May 26, 1994
Days to Decision 111 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
11d faster than avg
Panel avg: 122d · This submission: 111d
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 K940515.
ACUFEX DISPOSABLE MENISCAL CANNULA
K932090 · Acufex Microsurgical, Inc. · Jun 1994
ACUMED FLEXIBLE CANNULA
K932099 · Acu Med, Inc. · Jun 1994
ARTHROSCOPE
K940090 · Richard Wolf Medical Instruments Corp. · Jun 1994
GORE SMOOTHER II AND GORE BPTB
K941269 · W.L. Gore & Associates, Inc. · May 1994
ACUFEX LINEAR/ROTARY INSTRUMENTS
K940981 · Acufex Microsurgical, Inc. · May 1994
ACUFEX(R) ARTHROPLASTY INSTRUMENTS
K940985 · Acufex Microsurgical, Inc. · May 1994