Cleared Traditional

ZINDRICK IM ROD (K871539) - FDA 510(k) Clearance

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

K871539 · Buckman Co., Inc. · Orthopedic device
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Aug 1987
Decision
119d
Days
Class 2
Risk

K871539 is an FDA 510(k) clearance for the ZINDRICK IM ROD. Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by Buckman Co., Inc. (Martinez, US). The FDA issued a Cleared decision on August 17, 1987 after a review of 119 days - within the typical 510(k) review window.

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: 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 Buckman Co., Inc. devices

Submission Details

510(k) Number K871539 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 1987
Decision Date August 17, 1987
Days to Decision 119 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
3d faster than avg
Panel avg: 122d · This submission: 119d
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 257
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K871539.
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
SARMIENTO FOREARM NAIL
K871814 · Depuy, Inc. · Jun 1987
HI MARC INTERLOCKING NAIL
K871872 · Depuy, Inc. · Jun 1987
GROSSE AND KEMPF LOCKING NAIL SYSTEM, NON-SLOT ROD
K860756 · Howmedica Corp. · Mar 1986