Cleared Traditional

K070928 - CERAMIC BALL HEADS

K070928 is an FDA 510(k) clearance for CERAMIC BALL HEADS, manufactured by Plus Orthopedics AG. The device is a Class 2 Orthopedic device with product code LZO cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K070928 · Plus Orthopedics AG · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2007
Decision
120d
Days
Class 2
Risk

K070928 is an FDA 510(k) clearance for the CERAMIC BALL HEADS, 28, 32 AND 36 MM. Classified as Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (product code LZO), Class II - Special Controls.

Submitted by Plus Orthopedics AG (Norfolk, US). The FDA issued a Cleared decision on August 1, 2007 after a review of 120 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 Plus Orthopedics AG devices

FDA 510(k) Submission Details - K070928

510(k) Number K070928 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 2007
Decision Date August 01, 2007
Days to Decision 120 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
2d faster than avg
Panel avg: 122d · This submission: 120d
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 436
Devices cleared under the same product code (LZO) and FDA review panel - the closest regulatory comparables to K070928.
DEPUY DELTA TS CERAMIC FEMORAL HEADS
K071830 · DePuy Orthopaedics, Inc. · Sep 2007
STRYKER MODULAR HIP SYSTEM
K071082 · Howmedica Osteonics Corp. · Sep 2007
DEPUY CORAIL AMT DYSPLASIA HIP PROSTHESIS
K070554 · DePuy Orthopaedics, Inc. · Sep 2007
UNIVERSAL TAPER DELTA FEMORAL HEAD
K070885 · Howmedica Osteonics Corp. · May 2007
EXACTECH NOVATION CROWN CUP AND LINERS
K070479 · Exactech, Inc. · Mar 2007
TRIDENT II ACETABULAR SYSTEM
K063616 · Howmedica Osteonics Corp. · Dec 2006