Cleared Traditional

K212512 - G7® Vivacit-E® Freedom® Constrained Liner (FDA 510(k) Clearance)

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

K212512 · Zimmer, Inc. · Orthopedic device
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Apr 2022
Decision
261d
Days
Class 2
Risk

K212512 is an FDA 510(k) clearance for the G7® Vivacit-E® Freedom® Constrained Liner. Classified as Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/polymer, + Additive (product code PBI), Class II - Special Controls.

Submitted by Zimmer, Inc. (Warsaw, US). The FDA issued a Cleared decision on April 28, 2022 after a review of 261 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3310 - 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 Zimmer, Inc. devices

Submission Details

510(k) Number K212512 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 2021
Decision Date April 28, 2022
Days to Decision 261 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
139d slower than avg
Panel avg: 122d · This submission: 261d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PBI Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/polymer, + Additive
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3310
Definition For Use As A Component Of A Total Hip Prosthesis In Primary And Revision Patients At High Risk Of Dislocation Due To A History Of Prior Dislocation, Bone Loss, Joint Or Soft Tissue Laxity, Neuromuscular Disease, Or Intraoperative Instability, And For Whom All Other Options To Constrained Acetabular Components Have Been Considered.
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.