Cleared Traditional

K902074 - KINAMED CEMENTED CTH STEM

K902074 is the FDA 510(k) clearance for KINAMED CEMENTED CTH STEM by Kinamed, Inc.. It is a Class 2 Orthopedic device (product code LZO) cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K902074 · Kinamed, Inc. · Orthopedic device
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Jun 1990
Decision
32d
Days
Class 2
Risk

K902074 is an FDA 510(k) clearance for the KINAMED CEMENTED CTH STEM. Classified as Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (product code LZO), Class II - Special Controls.

Submitted by Kinamed, Inc. (Newbury Park, US). The FDA issued a Cleared decision on June 8, 1990 after a review of 32 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3353 - 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 Kinamed, Inc. devices

Submission Details

510(k) Number K902074 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received May 07, 1990
Decision Date June 08, 1990
Days to Decision 32 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
90d faster than avg
Panel avg: 122d · This submission: 32d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LZO Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3353
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 - LZO Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented

All 435
Devices cleared under the same product code (LZO) and FDA review panel - the closest regulatory comparables to K902074.
CTH STABILO TOTAL HIP REPLACEMENT SYSTEM
K903976 · Kinamed, Inc. · Jan 1991
OSTEONICS PS HEAD AND NECK HIP STEM SERIES
K902712 · Osteonics Corp. · Aug 1990
KINAMED CEMENTED ATH-LONG STEM
K902073 · Kinamed, Inc. · Jun 1990
MODULAR HIP SYSTEM
K900628 · Richards Medical Co., Inc. · May 1990
KINAMED CERAMIC ATH TOTAL HIP - 28MM BALL
K894904 · Kinamed, Inc. · Mar 1990
KIM MODULAR FEMORAL HIP PROSTHESIS
K895399 · Dow Corning Wright · Dec 1989