Cleared Traditional

K855017 - LSF* TOTAL HIP SYSTEM

K855017 is an FDA 510(k) clearance for LSF* TOTAL HIP SYSTEM, manufactured by Implant Technology, Inc.. The device is a Class 2 Orthopedic device with product code JDI cleared through the Traditional 510(k) pathway after a 177-day FDA review.

K855017 · Implant Technology, Inc. · Orthopedic device
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Jun 1986
Decision
177d
Days
Class 2
Risk

K855017 is an FDA 510(k) clearance for the LSF* TOTAL HIP SYSTEM. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by Implant Technology, Inc. (Secaucus, US). The FDA issued a Cleared decision on June 11, 1986 after a review of 177 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3350 - 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 Implant Technology, Inc. devices

FDA 510(k) Submission Details - K855017

510(k) Number K855017 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received December 16, 1985
Decision Date June 11, 1986
Days to Decision 177 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
55d slower than avg
Panel avg: 122d · This submission: 177d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JDI Device Classification - Class 2, Special Controls

Product Code JDI Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3350
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 - JDI Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented

All 524
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K855017.
UNIVERSAL ACETABULAR COMPONENT
K861433 · Biomet, Inc. · Oct 1986
EXACTECH TOTAL HIP SYSTEM
K862234 · Exactech, Inc. · Oct 1986
INTERNATIONAL TOTAL HIP SYSTEM
K862225 · Richards Medical Co., Inc. · Jul 1986
CM-6 TOTAL HIP SYSTEM
K861930 · Kirschner Medical Corp. · Jun 1986
MALLORY/HEAD - PF ACETABULAR COMPONENT
K861114 · Biomet, Inc. · Apr 1986
MODULAR PRESS FIT (MPF) STEM
K855200 · Depuy, Inc. · Apr 1986