Cleared Traditional

K915548 - IONGUARD TITANIUM MODULAR HEADS

K915548 is an FDA 510(k) clearance for IONGUARD TITANIUM MODULAR HEADS, manufactured by Biomet, Inc.. The device is a Class 2 Orthopedic device with product code LZY cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K915548 · Biomet, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1992
Decision
90d
Days
Class 2
Risk

K915548 is an FDA 510(k) clearance for the IONGUARD TITANIUM MODULAR HEADS. Classified as Prosthesis, Hip, Hemi-, Femoral, Metal Ball (product code LZY), Class II - Special Controls.

Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on March 10, 1992 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3360 - 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 Biomet, Inc. devices

FDA 510(k) Submission Details - K915548

510(k) Number K915548 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 1991
Decision Date March 10, 1992
Days to Decision 90 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 122d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LZY Device Classification - Class 2, Special Controls

Product Code LZY Prosthesis, Hip, Hemi-, Femoral, Metal Ball
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3360
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.