Cleared Special

K993352 - CROSSFIRE SYSTEM 12 ACETABULAR INSERTS

K993352 is the FDA 510(k) clearance for CROSSFIRE SYSTEM 12 ACETABULAR INSERTS by Howmedica Osteonics Corp.. It is a Class 2 Orthopedic device (product code LPH) cleared through the Special 510(k) pathway after a 45-day FDA review.

K993352 · Howmedica Osteonics Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1999
Decision
45d
Days
Class 2
Risk

K993352 is an FDA 510(k) clearance for the CROSSFIRE SYSTEM 12 ACETABULAR INSERTS. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (product code LPH), Class II - Special Controls.

Submitted by Howmedica Osteonics Corp. (Allendale, US). The FDA issued a Cleared decision on November 19, 1999 after a review of 45 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3358 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Howmedica Osteonics Corp. devices

Submission Details

510(k) Number K993352 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 05, 1999
Decision Date November 19, 1999
Days to Decision 45 days
Submission Type Special
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
77d faster than avg
Panel avg: 122d · This submission: 45d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code LPH Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3358
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 - LPH Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented

All 444
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K993352.
MODULAR REACH HIP
K994038 · Biomet, Inc. · Dec 1999
DURATION IV STERILIZATION PROCESS (ACETABULAR INSERTS)
K990849 · Howmedica Osteonics Corp. · Dec 1999
EXACTECH ACUMATCH INTEGRATED HIP SYSTEM A-SERIES POROUS COATED ACETABULAR COMPONENT
K993082 · Exactech, Inc. · Nov 1999
ZMR HIP SYSTEM-REVISION TAPER
K992667 · Zimmer, Inc. · Oct 1999
REFLECTION CROSSLINKED UHMWPE ACETABULAR COMPONENTS
K991026 · Smith & Nephew, Inc. · Oct 1999
ENCORE FULLY COATED HIP
K992109 · Encore Orthopedics, Inc. · Aug 1999