Cleared Traditional

K902727 - LSF CEMENTED FEMORAL HIP

K902727 is an FDA 510(k) clearance for LSF CEMENTED FEMORAL 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 49-day FDA review.

K902727 · Implant Technology, Inc. · Orthopedic device
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Aug 1990
Decision
49d
Days
Class 2
Risk

K902727 is an FDA 510(k) clearance for the LSF CEMENTED FEMORAL 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 August 9, 1990 after a review of 49 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 - K902727

510(k) Number K902727 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 1990
Decision Date August 09, 1990
Days to Decision 49 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 122d · This submission: 49d
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 K902727.
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ACETABULAR CUP
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K903243 · Onyx Medical Corp. · Jul 1990
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K902137 · Johnson & Johnson Orthopaedics, Inc. · Jun 1990