Cleared Traditional

K201157 - Prime BIOFOAM® Multi-Hole Shells (FDA 510(k) Clearance)

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K201157 · Microport Orthopedics, Inc. · Orthopedic device
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Aug 2021
Decision
481d
Days
Class 2
Risk

K201157 is an FDA 510(k) clearance for the Prime BIOFOAM® Multi-Hole Shells. Classified as Prosthesis, Hip, Semi-constrained, Uncemented, Metal/polymer, Porous (product code MBL), Class II - Special Controls.

Submitted by Microport Orthopedics, Inc. (Arlington, US). The FDA issued a Cleared decision on August 24, 2021 after a review of 481 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3358 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Orthopedic submissions.

View all Microport Orthopedics, Inc. devices

Submission Details

510(k) Number K201157 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 2020
Decision Date August 24, 2021
Days to Decision 481 days
Submission Type Traditional
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
359d slower than avg
Panel avg: 122d · This submission: 481d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MBL Prosthesis, Hip, Semi-constrained, Uncemented, Metal/polymer, Porous
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.