Cleared Traditional

K934321 - LINVATEC STASYS-PES FIXATION DEVICE

K934321 is the FDA 510(k) clearance for LINVATEC STASYS-PES FIXATION DEVICE by Linvatec Corp.. It is a Class 2 Orthopedic device (product code HWC) cleared through the Traditional 510(k) pathway after a 614-day FDA review.

K934321 · Linvatec Corp. · Orthopedic device
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May 1995
Decision
614d
Days
Class 2
Risk

K934321 is an FDA 510(k) clearance for the LINVATEC STASYS-PES FIXATION DEVICE. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Linvatec Corp. (Largo, US). The FDA issued a Cleared decision on May 10, 1995 after a review of 614 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Orthopedic submissions.

View all Linvatec Corp. devices

Submission Details

510(k) Number K934321 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 1993
Decision Date May 10, 1995
Days to Decision 614 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
492d slower than avg
Panel avg: 122d · This submission: 614d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HWC Screw, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
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 - HWC Screw, Fixation, Bone

All 556
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K934321.
HARPOON SUTURE ANCHORS
K943806 · Biomet, Inc. · Jul 1995
SYNTHES 2.7 MM CANNULATED SCREW AND THREADED WASHER
K951304 · Synthes (Usa) · Jun 1995
IMPROVED PASSIVATION METHOD FOR METALLIC ORTHOPAEDIC IMPLANTS
K934590 · Smith & Nephew Richards, Inc. · Jun 1995
ACUTRAK PLUS FIXATION SYSTEM
K944330 · Acu Med, Inc. · May 1995
ARTHREX CANCELLOUS SCREW AND WASHER
K945426 · Arthrex, Inc. · Apr 1995
BONE MULCH SCREW
K941941 · Biomet, Inc. · Feb 1995