Cleared Traditional

K971059 - UNIVERSAL DRIVE SYSTEM

K971059 is an FDA 510(k) clearance for UNIVERSAL DRIVE SYSTEM, 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 86-day FDA review.

K971059 · Linvatec Corp. · Orthopedic device
Download Printable Device Report (PDF)
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Jun 1997
Decision
86d
Days
Class 2
Risk

K971059 is an FDA 510(k) clearance for the UNIVERSAL DRIVE SYSTEM. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Linvatec Corp. (Largo, US). The FDA issued a Cleared decision on June 18, 1997 after a review of 86 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

FDA 510(k) Submission Details - K971059

510(k) Number K971059 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 1997
Decision Date June 18, 1997
Days to Decision 86 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 122d · This submission: 86d
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 521
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K971059.
MEDIVISION ARTHROSCOP
K971996 · Medivision Scope Service Center, Inc. · Jul 1997
LIMITED REUSE ENDOSCOPIC BLADES
K971676 · Smith & Nephew, Inc. · Jun 1997
ARTHROSCOPE
K971083 · Electro-Biology, Inc. · Jun 1997
VARIOUS ARTHROSCOPES, ENDOSCOPIC BLADES, MANUAL INSTRUMENTS
K971253 · Smith & Nephew, Inc. · Jun 1997
TENOSCOPE
K970642 · Luxtec Corp. · May 1997
TENOSNARE
K970562 · Luxtec Corp. · May 1997