Cleared Traditional

K971020 - LSF TRIAD TOTAL HIP SYSTEM

K971020 is an FDA 510(k) clearance for LSF TRIAD TOTAL HIP SYSTEM, manufactured by Osteoimplant Technology, Inc.. The device is a Class 2 Orthopedic device with product code LPH cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K971020 · Osteoimplant Technology, Inc. · Orthopedic device
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Jun 1997
Decision
90d
Days
Class 2
Risk

K971020 is an FDA 510(k) clearance for the LSF TRIAD TOTAL HIP SYSTEM. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (product code LPH), Class II - Special Controls.

Submitted by Osteoimplant Technology, Inc. (Hunt Valley, US). The FDA issued a Cleared decision on June 18, 1997 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3358 - 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 Osteoimplant Technology, Inc. devices

FDA 510(k) Submission Details - K971020

510(k) Number K971020 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 1997
Decision Date June 18, 1997
Days to Decision 90 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 122d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LPH Device Classification - Class 2, Special Controls

Product Code LPH Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3358
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 - LPH Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented

All 476
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K971020.
NATURAL-HIP SYSTEM POROUS STEM WITH HA/CSTI
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K964650 · Depuy, Inc. · Jun 1997
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K970705 · Sulzer Orthopedics, Inc. · May 1997
INTER-OP POROUS PROTRUSIO SHELL WITH SEALABLE SCREWHOLES
K970706 · Sulzer Orthopedics, Inc. · May 1997
PEGGED ACETABULAR COMPONENT
K970501 · Biomet, Inc. · Apr 1997