Cleared Traditional

K211047 - CoCr Head

K211047 is the FDA 510(k) clearance for CoCr Head by Zimmer GmbH. It is a Class 2 Orthopedic device (product code LPH) cleared through the Traditional 510(k) pathway after a 642-day FDA review.

K211047 · Zimmer GmbH · Orthopedic device
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Jan 2023
Decision
642d
Days
Class 2
Risk

K211047 is an FDA 510(k) clearance for the CoCr Head. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (product code LPH), Class II - Special Controls.

Submitted by Zimmer GmbH (Winterthur, CH). The FDA issued a Cleared decision on January 10, 2023 after a review of 642 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 Zimmer GmbH devices

Submission Details

510(k) Number K211047 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 2021
Decision Date January 10, 2023
Days to Decision 642 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
520d slower than avg
Panel avg: 122d · This submission: 642d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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

Regulatory Peers - LPH Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented

All 428
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