Cleared Traditional

K853259 - MALLORY/HEAD TOTAL HIP SYSTEM

K853259 is an FDA 510(k) clearance for MALLORY/HEAD TOTAL HIP SYSTEM, manufactured by Biomet, Inc.. The device is a Class 2 Orthopedic device with product code KMC cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K853259 · Biomet, Inc. · Orthopedic device
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Nov 1985
Decision
91d
Days
Class 2
Risk

K853259 is an FDA 510(k) clearance for the MALLORY/HEAD TOTAL HIP SYSTEM. Classified as Prosthesis, Hip, Semi-constrained, Composite/metal (product code KMC), Class II - Special Controls.

Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on November 1, 1985 after a review of 91 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3340 - 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 - K853259

510(k) Number K853259 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received August 02, 1985
Decision Date November 01, 1985
Days to Decision 91 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 122d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KMC Device Classification - Class 2, Special Controls

Product Code KMC Prosthesis, Hip, Semi-constrained, Composite/metal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3340
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.