Cleared Traditional

K991964 - EIS THREADED SCREW FRACTURE FIXATION

K991964 is an FDA 510(k) clearance for EIS THREADED SCREW FRACTURE FIXATION, manufactured by Groupe Lepine. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 193-day FDA review.

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

FDA 510(k) Submission Details - K991964

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
Combination Product No
PCCP Authorized No
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.

HWC Device Classification - Class 2, Special Controls

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 804
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K991964.
I.CO.S SCREW
K993762 · New Deal, S.A. · Feb 2000
SYNTHES 4.0 AND 5.0 MM LOCKING SCREWS
K000089 · Synthes (Usa) · Feb 2000
BIORCI SCREW
K992396 · Smith & Nephew Endoscopy, Inc. · Jan 2000
ABSOLUTE ABSORBABLE INTERFERENCE SCREW
K993975 · Innovasive Devices, Inc. · Dec 1999
RCI FIXATION SCREWS (WITH ASSORTED SIZES)
K992945 · Smith & Nephew, Inc. · Nov 1999
BONE BULLET SUTURE ANCHOR
K991024 · Linvatec Corp. · Nov 1999