Cleared Traditional

K954440 - APEX TUBING SET

K954440 is the FDA 510(k) clearance for APEX TUBING SET by Linvatec Corp.. It is a Class 2 Orthopedic device (product code HRX) cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K954440 · Linvatec Corp. · Orthopedic device
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Nov 1995
Decision
38d
Days
Class 2
Risk

K954440 is an FDA 510(k) clearance for the APEX 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 November 2, 1995 after a review of 38 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 K954440 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 1995
Decision Date November 02, 1995
Days to Decision 38 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
84d faster than avg
Panel avg: 122d · This submission: 38d
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 K954440.
RETRACTOR
K954508 · Phx Technologies Corp. · Nov 1995
PROBE KNIFE
K954509 · Phx Technologies Corp. · Nov 1995
RRIANGLE KNIFE
K954510 · Phx Technologies Corp. · Nov 1995
BOAT NOSE OBTURATOR
K954458 · Phx Technologies Corp. · Oct 1995
CONICAL OBTURATOR
K954459 · Phx Technologies Corp. · Oct 1995
DISSECTING OBTURATOR
K954463 · Phx Technologies Corp. · Oct 1995