Cleared Traditional

K871814 - SARMIENTO FOREARM NAIL

K871814 is the FDA 510(k) clearance for SARMIENTO FOREARM NAIL by Depuy, Inc.. It is a Class 2 Orthopedic device (product code HSB) cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K871814 · Depuy, Inc. · Orthopedic device
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Jun 1987
Decision
50d
Days
Class 2
Risk

K871814 is an FDA 510(k) clearance for the SARMIENTO FOREARM NAIL. Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by Depuy, Inc. (Warsaw, US). The FDA issued a Cleared decision on June 30, 1987 after a review of 50 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3020 - 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 Depuy, Inc. devices

Submission Details

510(k) Number K871814 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 1987
Decision Date June 30, 1987
Days to Decision 50 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 122d · This submission: 50d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HSB Rod, Fixation, Intramedullary And Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3020
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 - HSB Rod, Fixation, Intramedullary And Accessories

All 338
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K871814.
ZINDRICK IM ROD INSTRUMENTS
K882443 · Buckman Co., Inc. · Jun 1988
ZINDRICK IM ROD
K871539 · Buckman Co., Inc. · Aug 1987
MODIFIED HUCKSTEP INTRAMEDULLARY NAIL
K871947 · Downs Surgical , Ltd. · Aug 1987
HI MARC INTERLOCKING NAIL
K871872 · Depuy, Inc. · Jun 1987
RODRIGUEZ NAIL
K871608 · Richards Medical Co., Inc. · May 1987
FASICULATED NAIL
K861365 · Lake Region Mfg., Inc. · May 1986