Cleared Traditional

SARMIENTO FOREARM NAIL (K871814) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K871814 · Depuy, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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 256
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K871814.
ALTA HOLLOW TIBIAL RODS
K890936 · Howmedica Corp. · Jun 1989
ALTA NON-REAMED TIBIAL ROD
K884500 · Howmedica Corp. · Jan 1989
INTERLOCKING INTRAMEDULLARY NAILS
K884610 · Depuy, Inc. · Dec 1988
HI MARC INTERLOCKING NAIL
K871872 · Depuy, Inc. · Jun 1987
GROSSE AND KEMPF LOCKING NAIL SYSTEM, NON-SLOT ROD
K860756 · Howmedica Corp. · Mar 1986
FEMOROTIBIAL MEDULLARY NAIL
K853250 · Zimmer, Inc. · Feb 1986