Cleared Traditional

K871462 - PROSTHETIC - FEMORAL HIP COMPONENT

K871462 is an FDA 510(k) clearance for PROSTHETIC - FEMORAL HIP COMPONENT, manufactured by Louis A. Serafin, Jr., M.D.. The device is a Class 2 Orthopedic device with product code JDI cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K871462 · Louis A. Serafin, Jr., M.D. · Orthopedic device
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Jun 1987
Decision
51d
Days
Class 2
Risk

K871462 is an FDA 510(k) clearance for the PROSTHETIC - FEMORAL HIP COMPONENT. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by Louis A. Serafin, Jr., M.D. (Port Huron, US). The FDA issued a Cleared decision on June 4, 1987 after a review of 51 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.

FDA 510(k) Submission Details - K871462

510(k) Number K871462 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received April 14, 1987
Decision Date June 04, 1987
Days to Decision 51 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 122d · This submission: 51d
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 552
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K871462.
MURRAY/WELCH TOTAL HIP SYSTEM
K871402 · Kirschner Medical Corp. · Jul 1987
WAGNER REVISIONAL FEMORAL HIP PROSTHESIS
K871347 · Protek, Inc. · Jul 1987
HPS II CALCAR FEMORAL PROSTHESIS
K871857 · Depuy, Inc. · Jun 1987
OMNIFIT II HIP PROSTHESES: CEMENT FIXATION
K870235 · Osteonics Corp. · May 1987
MODIFIED PROFILE HIP PMMA CEMENT SPACER
K871510 · Depuy, Inc. · May 1987
KIRSCHNER MODULAR HIP SYSTEM
K871401 · Kirschner Medical Corp. · May 1987
K871462 · PROSTHETIC - FEMORAL HIP COMPONENT
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