Cleared Special

SC CERAMIC BALL HEADS (K052237) - FDA 510(k) Clearance

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K052237 · Orthopedic Alliance, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2005
Decision
20d
Days
Class 2
Risk

K052237 is an FDA 510(k) clearance for the SC CERAMIC BALL HEADS. Classified as Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (product code LZO), Class II - Special Controls.

Submitted by Orthopedic Alliance, LLC (Murrieta, US). The FDA issued a Cleared decision on September 6, 2005 after a review of 20 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3353 - 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 Orthopedic Alliance, LLC devices

Submission Details

510(k) Number K052237 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 2005
Decision Date September 06, 2005
Days to Decision 20 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
102d faster than avg
Panel avg: 122d · This submission: 20d
Pathway characteristics
Modification to existing cleared device.

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 291
Devices cleared under the same product code (LZO) and FDA review panel - the closest regulatory comparables to K052237.
ACUMATCH M-SERIES LPB 12/14 FEMORAL STEM
K051858 · Exactech, Inc. · Dec 2005
EXACTECH ZIRAMIC ZIRCONIA 12/14 FEMORAL HEADS
K050398 · Exactech, Inc. · Nov 2005
V40 BIOLOX DELTA CERAMIC FEMORAL HEADS
K052718 · Howmedica Osteonics Corp. · Oct 2005
EXACTECH 12/14 ALUMINA FEMORAL HEADS 36 MM
K051682 · Exactech, Inc. · Jul 2005
MODIFICATION TO V-40/C-TAPER ADAPTER SLEEVE
K051737 · Howmedica Osteonics Corp. · Jul 2005
SECUR-FIT MAX AND PLUS MAX HIP STEMS
K051738 · Howmedica Osteonics Corp. · Jul 2005