Cleared Traditional

K894904 - KINAMED CERAMIC ATH TOTAL HIP - 28MM BALL

K894904 is the FDA 510(k) clearance for KINAMED CERAMIC ATH TOTAL HIP - 28MM BALL by Kinamed, Inc.. It is a Class 2 Orthopedic device (product code LZO) cleared through the Traditional 510(k) pathway after a 230-day FDA review.

K894904 · Kinamed, Inc. · Orthopedic device
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Mar 1990
Decision
230d
Days
Class 2
Risk

K894904 is an FDA 510(k) clearance for the KINAMED CERAMIC ATH TOTAL HIP - 28MM BALL. 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. (Washington, US). The FDA issued a Cleared decision on March 19, 1990 after a review of 230 days - an extended review 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: 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 Kinamed, Inc. devices

Submission Details

510(k) Number K894904 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received August 01, 1989
Decision Date March 19, 1990
Days to Decision 230 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
108d slower than avg
Panel avg: 122d · This submission: 230d
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 K894904.
KINAMED CEMENTED ATH-LONG STEM
K902073 · Kinamed, Inc. · Jun 1990
KINAMED CEMENTED CTH STEM
K902074 · Kinamed, Inc. · Jun 1990
MODULAR HIP SYSTEM
K900628 · Richards Medical Co., Inc. · May 1990
KIM MODULAR FEMORAL HIP PROSTHESIS
K895399 · Dow Corning Wright · Dec 1989
ZIRCONIA CERAMIC HEAD ADD'L SIZES
K896204 · Richards Medical Co., Inc. · Nov 1989
OMNIFIT CERAMIC MORSE TAPER HEAD
K894694 · Osteonics Corp. · Oct 1989