Cleared Traditional

K864999 - KENNEDY STEM

K864999 is an FDA 510(k) clearance for KENNEDY STEM, manufactured by Allo Pro Corp.. The device is a Class 2 Orthopedic device with product code JDI cleared through the Traditional 510(k) pathway after a 261-day FDA review.

K864999 · Allo Pro Corp. · Orthopedic device
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Sep 1987
Decision
261d
Days
Class 2
Risk

K864999 is an FDA 510(k) clearance for the KENNEDY STEM. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by Allo Pro Corp. (Clearwater, US). The FDA issued a Cleared decision on September 9, 1987 after a review of 261 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 Allo Pro Corp. devices

FDA 510(k) Submission Details - K864999

510(k) Number K864999 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 1986
Decision Date September 09, 1987
Days to Decision 261 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
139d slower than avg
Panel avg: 122d · This submission: 261d
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 519
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K864999.
POROUS COATED ACETABULAR CUP
K873585 · Johnson & Johnson Professionals, Inc. · Oct 1987
PREMIER-TOTAL (TM) HIP
K873999 · Intermedics Orthopedics · Oct 1987
MCCUTCHEN ACETABULAR CUP PROSTHESIS
K872732 · Dow Corning Wright · Oct 1987
BIOPRO 32MM BALL
K872856 · Biopro, Inc. · Aug 1987
MURRAY/WELCH TOTAL HIP SYSTEM
K871402 · Kirschner Medical Corp. · Jul 1987
WAGNER REVISIONAL FEMORAL HIP PROSTHESIS
K871347 · Protek, Inc. · Jul 1987