Cleared Traditional

K895399 - KIM MODULAR FEMORAL HIP PROSTHESIS

K895399 is an FDA 510(k) clearance for KIM MODULAR FEMORAL HIP PROSTHESIS, manufactured by Dow Corning Wright. The device is a Class 2 Orthopedic device with product code LZO cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K895399 · Dow Corning Wright · Orthopedic device
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Dec 1989
Decision
98d
Days
Class 2
Risk

K895399 is an FDA 510(k) clearance for the KIM MODULAR FEMORAL HIP PROSTHESIS. Classified as Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (product code LZO), Class II - Special Controls.

Submitted by Dow Corning Wright (Arlington, US). The FDA issued a Cleared decision on December 14, 1989 after a review of 98 days - within the typical 510(k) review window.

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 Dow Corning Wright devices

FDA 510(k) Submission Details - K895399

510(k) Number K895399 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 1989
Decision Date December 14, 1989
Days to Decision 98 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
24d faster than avg
Panel avg: 122d · This submission: 98d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LZO Device Classification - Class 2, Special Controls

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 K895399.
KINAMED CEMENTED CTH STEM
K902074 · 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
ZIRCONIA CERAMIC HEAD ADD'L SIZES
K896204 · Richards Medical Co., Inc. · Nov 1989
OMNIFIT CERAMIC MORSE TAPER HEAD
K894694 · Osteonics Corp. · Oct 1989
CERAMIC FEMORAL HEAD
K893685 · Dow Corning Wright · Sep 1989