Cleared Traditional

K965098 - INTRAMEDULLARY NAIL SYSTEM

K965098 is an FDA 510(k) clearance for INTRAMEDULLARY NAIL SYSTEM, manufactured by Zimmer, Inc.. The device is a Class 2 Orthopedic device with product code HSB cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K965098 · Zimmer, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1997
Decision
70d
Days
Class 2
Risk

K965098 is an FDA 510(k) clearance for the INTRAMEDULLARY NAIL SYSTEM. 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 February 28, 1997 after a review of 70 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

FDA 510(k) Submission Details - K965098

510(k) Number K965098 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 1996
Decision Date February 28, 1997
Days to Decision 70 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
52d faster than avg
Panel avg: 122d · This submission: 70d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HSB Device Classification - Class 2, Special Controls

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 K965098.
FIXANO D.S.S. (DOUBLE SLIDING SCREWS) SYSTEM FOR OSTEOSYNTHESIS OF PER-TROCHANTEROAM FRACTURES
K970280 · Ferguson Medical · May 1997
BTI DISTAL FEMORAL INTRAMEDULLARY ROD SYSTEM
K970897 · Biodynamic Technologies, Inc. · Apr 1997
TRUE/FIT FEMORAL INTRAMEDULLARY ROD SYSTEM
K961360 · Encore Orthopedics, Inc. · Mar 1997
TRIMAX NAIL SYSTEM
K964163 · Smith & Nephew Richards, Inc. · Dec 1996
TBD
K963026 · Acu Med, Inc. · Oct 1996
TBD
K963077 · Acu Med, Inc. · Oct 1996