Cleared Traditional

SUPRACONDYLAR INTRAMEDULLARY NAIL (K962561) - FDA 510(k) Clearance

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

K962561 · Zimmer, Inc. · Orthopedic device
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Sep 1996
Decision
86d
Days
Class 2
Risk

K962561 is an FDA 510(k) clearance for the SUPRACONDYLAR INTRAMEDULLARY NAIL. Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by Zimmer, Inc. (Warsaw, US). The FDA issued a Cleared decision on September 25, 1996 after a review of 86 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 Zimmer, Inc. devices

Submission Details

510(k) Number K962561 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 1996
Decision Date September 25, 1996
Days to Decision 86 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
36d faster than avg
Panel avg: 122d · This submission: 86d
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 K962561.
ATLAS FRACTURE PROXIMAL HUMERAL NAIL
K971816 · Biomet, Inc. · Jul 1997
MAGELLAN INTRAMEDULLARY FEMORAL NAIL SYSTEM
K971135 · Wrightmedicaltechnologyinc · Jun 1997
INTRAMEDULLARY NAIL SYSTEM
K965098 · Zimmer, Inc. · Feb 1997
ALTA CFX IM ROD SYSTEM
K960524 · Howmedica Corp. · Mar 1996
TI-6AL-7NB URTN
K932330 · Synthes (Usa) · Mar 1996
ALTA TIBIAL/HUMERAL ROD
K954554 · Howmedica Corp. · Dec 1995