Cleared Traditional

K925512 - CERAMIC FEMORAL HEAD-28MM LONG

K925512 is an FDA 510(k) clearance for CERAMIC FEMORAL HEAD-28MM LONG, 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 210-day FDA review.

K925512 · Dow Corning Wright · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1993
Decision
210d
Days
Class 2
Risk

K925512 is an FDA 510(k) clearance for the CERAMIC FEMORAL HEAD-28MM LONG, MODIFICATION. 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 February 12, 1993 after a review of 210 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 Dow Corning Wright devices

FDA 510(k) Submission Details - K925512

510(k) Number K925512 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 1992
Decision Date February 12, 1993
Days to Decision 210 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
88d slower than avg
Panel avg: 122d · This submission: 210d
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 K925512.
TOTAL HIP PROTHESIS FEMORAL COMPONENT
K923734 · Intermedics Orthopedics · Jun 1993
INFINITY(R) COLLARLESS/MICROTAPER TROCHANTERIC MOD
K920968 · Dow Corning Wright · May 1993
OMNIFIT ZIRCONIA C-TAPER FEMORAL BEARING HEAD
K925695 · Osteonics Corp. · Apr 1993
ORTHOMET PERFECTA TOTAL HIP SYSTEM
K923583 · Orthomet, Inc. · Dec 1992
PERFECTA TOTAL HIP SYSTEM, CERAMIC FEMORAL HEAD
K921836 · Orthomet, Inc. · Nov 1992
ZIRCONIA CERAMIC MODULAR HEAD 9TYPE II TAPER
K915641 · Biomet, Inc. · Nov 1992