Cleared Traditional

K191463 - DePuy Synthes Hammertoe Continuous Comp...

K191463 is the FDA 510(k) clearance for DePuy Synthes Hammertoe Continuous Comp... by Synthes USA Products, LLC. It is a Class 2 Orthopedic device (product code JDR) cleared through the Traditional 510(k) pathway after a 268-day FDA review.

K191463 · Synthes USA Products, LLC · Orthopedic device
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Feb 2020
Decision
268d
Days
Class 2
Risk

K191463 is an FDA 510(k) clearance for the DePuy Synthes Hammertoe Continuous Compression Implant. Classified as Staple, Fixation, Bone (product code JDR), Class II - Special Controls.

Submitted by Synthes USA Products, LLC (West Chester, US). The FDA issued a Cleared decision on February 26, 2020 after a review of 268 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 Synthes USA Products, LLC devices

Submission Details

510(k) Number K191463 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 2019
Decision Date February 26, 2020
Days to Decision 268 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
146d slower than avg
Panel avg: 122d · This submission: 268d
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 99
Devices cleared under the same product code (JDR) and FDA review panel - the closest regulatory comparables to K191463.
Arthrex DynaNite Nitinol Staples
K203180 · Arthrex, Inc. · Dec 2020
DynaClip Bone Staple
K193305 · MedShape, Inc. · Apr 2020
Superelastic Staple
K192447 · Neosteo · Feb 2020
TriMAX Implant System
K190722 · Crossroads Extemity Systems, LLC · Aug 2019
APTUS Foot System
K191636 · Medartis AG · Aug 2019
TriMed Nitinol Staple System
K190166 · TriMed, Inc. · Jul 2019