Cleared Traditional

K961360 - TRUE/FIT FEMORAL INTRAMEDULLARY ROD SYSTEM

K961360 is an FDA 510(k) clearance for TRUE/FIT FEMORAL INTRAMEDULLARY ROD SYSTEM, manufactured by Encore Orthopedics, Inc.. The device is a Class 2 Orthopedic device with product code HSB cleared through the Traditional 510(k) pathway after a 338-day FDA review.

K961360 · Encore Orthopedics, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1997
Decision
338d
Days
Class 2
Risk

K961360 is an FDA 510(k) clearance for the TRUE/FIT FEMORAL INTRAMEDULLARY ROD SYSTEM. Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by Encore Orthopedics, Inc. (Austin, US). The FDA issued a Cleared decision on March 13, 1997 after a review of 338 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Encore Orthopedics, Inc. devices

FDA 510(k) Submission Details - K961360

510(k) Number K961360 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 1996
Decision Date March 13, 1997
Days to Decision 338 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
216d slower than avg
Panel avg: 122d · This submission: 338d
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 K961360.
FIXANO D.S.S. (DOUBLE SLIDING SCREWS) SYSTEM FOR OSTEOSYNTHESIS OF SUB-TROCHANTERIAN FRACTURES
K970257 · Ferguson Medical · May 1997
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
INTRAMEDULLARY NAIL SYSTEM
K965098 · Zimmer, Inc. · Feb 1997
TRIMAX NAIL SYSTEM
K964163 · Smith & Nephew Richards, Inc. · Dec 1996
TBD
K963026 · Acu Med, Inc. · Oct 1996