Cleared Traditional

K011716 - THE UNI-CLIP STAPLE

K011716 is an FDA 510(k) clearance for THE UNI-CLIP STAPLE, manufactured by New Deal, S.A.. The device is a Class 2 Orthopedic device with product code JDR cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K011716 · New Deal, S.A. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2001
Decision
87d
Days
Class 2
Risk

K011716 is an FDA 510(k) clearance for the THE UNI-CLIP STAPLE. Classified as Staple, Fixation, Bone (product code JDR), Class II - Special Controls.

Submitted by New Deal, S.A. (Potomac, US). The FDA issued a Cleared decision on August 30, 2001 after a review of 87 days - a notably fast clearance 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: 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 New Deal, S.A. devices

FDA 510(k) Submission Details - K011716

510(k) Number K011716 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 2001
Decision Date August 30, 2001
Days to Decision 87 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 122d · This submission: 87d
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 202
Devices cleared under the same product code (JDR) and FDA review panel - the closest regulatory comparables to K011716.
SURETAC III, MODELS 7209900, 7209901
K023417 · Smith & Nephew, Inc. · Nov 2002
SMITH & NEPHEW SURETAC - EXPANDED INDICATIONS II
K020948 · Smith & Nephew, Inc. · Oct 2002
DYNAMIC COMPRESSION SHAPE MEMORY ALLOY (SMA) STAPLE SYSTEM
K012081 · Medtronic Sofamor Danek, Inc. · Oct 2001
SCAPHIX, STAPLE, FIXATION, BONE
K003033 · Avanta Orthopaedics, Inc. · May 2001
MEMOGRAPH STAPLE, WARM SYSTEM
K993714 · Biomedical Ent., Inc. · Feb 2000
EIS DYNAMIC MEMORY STAPLES SYSTEM
K991962 · Groupe Lepine · Jan 2000