Cleared Traditional

K893685 - CERAMIC FEMORAL HEAD

K893685 is an FDA 510(k) clearance for CERAMIC FEMORAL HEAD, 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 133-day FDA review.

K893685 · Dow Corning Wright · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1989
Decision
133d
Days
Class 2
Risk

K893685 is an FDA 510(k) clearance for the CERAMIC FEMORAL HEAD. 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 September 26, 1989 after a review of 133 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 - K893685

510(k) Number K893685 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 1989
Decision Date September 26, 1989
Days to Decision 133 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
11d slower than avg
Panel avg: 122d · This submission: 133d
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 K893685.
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
ZIRCONIA CERAMIC HEAD (YITRIA STABILIZED)
K885069 · Richards Medical Co., Inc. · Sep 1989
ATH CERAMIC UHMWPE TOTAL HIP SYSTEM
K890472 · Kinamed, Inc. · Sep 1989
OMNIFIT CERAMIC MORSE TAPER HEAD (1002 SERIES)
K885102 · Osteonics Corp. · Jun 1989