Cleared Traditional

K991566 - SOLUSTAPLE

K991566 is the FDA 510(k) clearance for SOLUSTAPLE by New Deal, S.A.. It is a Class 2 Orthopedic device (product code JDR) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K991566 · New Deal, S.A. · Orthopedic device
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Aug 1999
Decision
90d
Days
Class 2
Risk

K991566 is an FDA 510(k) clearance for the SOLUSTAPLE. 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 3, 1999 after a review of 90 days - within the typical 510(k) review window.

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 New Deal, S.A. devices

Submission Details

510(k) Number K991566 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 05, 1999
Decision Date August 03, 1999
Days to Decision 90 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
32d faster than avg
Panel avg: 122d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 124
Devices cleared under the same product code (JDR) and FDA review panel - the closest regulatory comparables to K991566.
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
THE UNI-CLIP STAPLE
K011716 · New Deal, S.A. · Aug 2001
UNI-CLIP STAPLE
K991482 · New Deal, S.A. · Jun 1999
MITEK MICRO ANCHOR
K982420 · Mitek Products · Aug 1998
LACTOSORB POP RIVET
K981798 · Biomet, Inc. · Jul 1998