Cleared Traditional

K991962 - EIS DYNAMIC MEMORY STAPLES SYSTEM

K991962 is an FDA 510(k) clearance for EIS DYNAMIC MEMORY STAPLES SYSTEM, manufactured by Groupe Lepine. The device is a Class 2 Orthopedic device with product code JDR cleared through the Traditional 510(k) pathway after a 214-day FDA review.

K991962 · Groupe Lepine · Orthopedic device
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Jan 2000
Decision
214d
Days
Class 2
Risk

K991962 is an FDA 510(k) clearance for the EIS DYNAMIC MEMORY STAPLES SYSTEM. Classified as Staple, Fixation, Bone (product code JDR), Class II - Special Controls.

Submitted by Groupe Lepine (Sarasota, US). The FDA issued a Cleared decision on January 10, 2000 after a review of 214 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - 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 - K991962

510(k) Number K991962 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 1999
Decision Date January 10, 2000
Days to Decision 214 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
92d slower than avg
Panel avg: 122d · This submission: 214d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JDR Device Classification - Class 2, Special Controls

Product Code JDR Staple, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
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 - JDR Staple, Fixation, Bone

All 159
Devices cleared under the same product code (JDR) and FDA review panel - the closest regulatory comparables to K991962.
THE UNI-CLIP STAPLE
K011716 · New Deal, S.A. · Aug 2001
SCAPHIX, STAPLE, FIXATION, BONE
K003033 · Avanta Orthopaedics, Inc. · May 2001
MEMOGRAPH STAPLE, WARM SYSTEM
K993714 · Biomedical Ent., Inc. · Feb 2000
SOLUSTAPLE
K991566 · New Deal, S.A. · Aug 1999
UNI-CLIP STAPLE
K991482 · New Deal, S.A. · Jun 1999
POLYMER OBL SB ANCHOR / SUTURE COMBINATION
K982996 · Orthopaedic Biosystems, Ltd. · Mar 1999