Cleared Traditional

K213387 - AltiVate® Anatomic Shoulder AG e+™ with Markers

K213387 is an FDA 510(k) clearance for AltiVate Anatomic Shoulder AG e+ with M..., manufactured by Encore Medical, L.P.. The device is a Class 2 Orthopedic device with product code KWS cleared through the Traditional 510(k) pathway after a 266-day FDA review.

K213387 · Encore Medical, L.P. · Orthopedic device
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Jul 2022
Decision
266d
Days
Class 2
Risk

K213387 is an FDA 510(k) clearance for the AltiVate® Anatomic Shoulder AG e+™ with Markers. Classified as Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented (product code KWS), Class II - Special Controls.

Submitted by Encore Medical, L.P. (Austin, US). The FDA issued a Cleared decision on July 7, 2022 after a review of 266 days - an extended review 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: 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 Encore Medical, L.P. devices

FDA 510(k) Submission Details - K213387

510(k) Number K213387 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 14, 2021
Decision Date July 07, 2022
Days to Decision 266 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
144d slower than avg
Panel avg: 122d · This submission: 266d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KWS Device Classification - Class 2, Special Controls

Product Code KWS Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3660
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 - KWS Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented

All 183
Devices cleared under the same product code (KWS) and FDA review panel - the closest regulatory comparables to K213387.
AETOS Shoulder System
K230572 · Smith & Nephew, Inc. · Jun 2023
AETOS Shoulder System
K220847 · Smith & Nephew, Inc. · Jan 2023
Catalyst EA Convertible Stemmed Shoulder
K222317 · Catalyst Orthoscience, Inc. · Nov 2022
SMR TT Hybrid Glenoid, SMR 3-Pegs Cemented Glenoid
K213785 · Limacorporate · May 2022
TITAN Total Shoulder System (TSS), TITAN Reverse Shoulder System (RSS), TITAN Humeral Resurfacing Arthroplasty System (HRA), Modular Radial Head System (MRH), Katalyst Bipolar Radial Head System (Katalyst)
K213827 · Smith & Nephew, Inc. · Mar 2022
Exactech® Equinoxe® Laser Cage Glenoid
K212356 · Exactech, Inc. · Mar 2022