Cleared Traditional

EIS THREADED SCREW FRACTURE FIXATION (K991964) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K991964 · Groupe Lepine · Orthopedic device
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Dec 1999
Decision
193d
Days
Class 2
Risk

K991964 is an FDA 510(k) clearance for the EIS THREADED SCREW FRACTURE FIXATION. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Groupe Lepine (Sarasota, US). The FDA issued a Cleared decision on December 20, 1999 after a review of 193 days - an extended review cycle.

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: 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 Groupe Lepine devices

Submission Details

510(k) Number K991964 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 1999
Decision Date December 20, 1999
Days to Decision 193 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
71d slower than avg
Panel avg: 122d · This submission: 193d
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 405
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K991964.
ASNIS III CANNULATED SCREW SYSTEM
K000080 · Howmedica Osteonics Corp. · Apr 2000
ACUFEX SPIKED WASHER SYSTEM, ACUFEX SUTURE WASHER SYSTEM, ACUFEX CANCELLOUS SCREW AND SPIKED WASHER SYSTEM
K994202 · Smith & Nephew, Inc. · Feb 2000
SYNTHES 4.0 AND 5.0 MM LOCKING SCREWS
K000089 · Synthes (Usa) · Feb 2000
RCI FIXATION SCREWS (WITH ASSORTED SIZES)
K992945 · Smith & Nephew, Inc. · Nov 1999
MODIFICATION TO BONE MULCH SCREW SYSTEM
K993025 · Biomet, Inc. · Oct 1999
BONE MULCH SCREW SYSTEM
K991298 · Biomet, Inc. · May 1999