Cleared Traditional

K191463 - DePuy Synthes Hammertoe Continuous Compression Implant

K191463 is an FDA 510(k) clearance for DePuy Synthes Hammertoe Continuous Comp..., manufactured by Synthes USA Products, LLC. The device is a Class 2 Orthopedic device with 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

FDA 510(k) Submission Details - K191463

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.

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 190
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