Cleared Traditional

K212992 - LINK Embrace Shoulder System - Reverse ...

K212992 is the FDA 510(k) clearance for LINK Embrace Shoulder System - Reverse ... by Waldemar Link GmbH & Co. KG. It is a Class 2 Orthopedic device (product code PHX) cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K212992 · Waldemar Link GmbH & Co. KG · Orthopedic device
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Nov 2021
Decision
59d
Days
Class 2
Risk

K212992 is an FDA 510(k) clearance for the LINK® Embrace Shoulder System - Reverse Configuration. Classified as Shoulder Prosthesis, Reverse Configuration (product code PHX), Class II - Special Controls.

Submitted by Waldemar Link GmbH & Co. KG (Norderstedt, DE). The FDA issued a Cleared decision on November 18, 2021 after a review of 59 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3660 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Waldemar Link GmbH & Co. KG devices

Submission Details

510(k) Number K212992 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 2021
Decision Date November 18, 2021
Days to Decision 59 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
63d faster than avg
Panel avg: 122d · This submission: 59d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PHX Shoulder Prosthesis, Reverse Configuration
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3660
Definition Intended To Be Used To Relieve Pain And To Replace The Glenoid And Humeral Side Of The Shoulder Joint In Order To Restore Mobility In A Grossly Rotator Cuff Deficient Joint With Severe Arthropathy Or A Previous Joint Replacement With A Grossly Rotator Cuff Deficient Joint.
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 Consultant

LinkBio Corp.
Terry Powell

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - PHX Shoulder Prosthesis, Reverse Configuration

All 178
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