Cleared Traditional

K913616 - LSF DIAGNOSTIC RELATED GROUP CEMENTED HIP

K913616 is an FDA 510(k) clearance for LSF DIAGNOSTIC RELATED GROUP CEMENTED HIP, 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 86-day FDA review.

K913616 · Implant Technology, Inc. · Orthopedic device
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Nov 1991
Decision
86d
Days
Class 2
Risk

K913616 is an FDA 510(k) clearance for the LSF DIAGNOSTIC RELATED GROUP CEMENTED HIP. 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 November 7, 1991 after a review of 86 days - a notably fast clearance cycle.

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

FDA 510(k) Submission Details - K913616

510(k) Number K913616 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 1991
Decision Date November 07, 1991
Days to Decision 86 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
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.

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 K913616.
INFINITY(TM) MICROTAPER HIP SYSTEM
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K913812 · Osteonics Corp. · Nov 1991
MODULAR CALCAR REPLACEMENT
K913649 · Zimmer, Inc. · Nov 1991
HYBRID FIT TOTAL HIP SYSTEM
K913246 · Kirschner Medical Corp. · Oct 1991
NATURAL POROUS HIP SYSTEM
K913060 · Intermedics Orthopedics · Oct 1991
APR II NON-POROUS HIP STEM
K913208 · Intermedics Orthopedics · Oct 1991