Cleared Traditional

K961590 - APEX UNIVERSAL IRRIGATION SYSTEM & TWO-...

K961590 is the FDA 510(k) clearance for APEX UNIVERSAL IRRIGATION SYSTEM & TWO-... by Linvatec Corp.. It is a Class 2 Orthopedic device (product code HRX) cleared through the Traditional 510(k) pathway after a 167-day FDA review.

K961590 · Linvatec Corp. · Orthopedic device
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Oct 1996
Decision
167d
Days
Class 2
Risk

K961590 is an FDA 510(k) clearance for the APEX UNIVERSAL IRRIGATION SYSTEM & TWO-CONNECTION TUBING SET. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Linvatec Corp. (Largo, US). The FDA issued a Cleared decision on October 8, 1996 after a review of 167 days - an extended review 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: 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 K961590 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 1996
Decision Date October 08, 1996
Days to Decision 167 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
45d slower than avg
Panel avg: 122d · This submission: 167d
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 360
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K961590.
KSEA LARGE JOINT ARTHROSCOPY SET
K963524 · Karl Storz Endoscopy · Nov 1996
THERMO-PLASTIC SHAVER BLADES
K963332 · Stryker Endoscopy · Oct 1996
KARL STORZ MAGNIFYING ARTHROSOCPES
K961228 · KARL STORZ Endoscopy-America, Inc. · Oct 1996
ARTHOCARE ARTHROSCOPIC ELECTROSURGERY SYSTEM MODEL 970
K962321 · Arthrocare Corp. · Jul 1996
ARTHROCARE ARTHROSCOPIC ELECTROSURGERY SYSTEM (MODEL 970)
K961747 · Arthrocare Corp. · Jul 1996
PROLINE FAST PASS ARTHOSCOPIC NEEDLE PASSER
K961853 · Acufex Microsurgical, Inc. · Jun 1996