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U.S. Department of Health and Human Services

Product Classification

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Device prosthesis, total anatomic shoulder, uncemented metaphyseal humeral stem with no diaphyseal incursion, semi-constrained
Regulation Description Shoulder joint metal/polymer semi-constrained cemented prosthesis.
Definition Replacement of the humeral head for total anatomic shoulder arthroplasty
Physical State Short metallic humeral stem contained entirely within the metaphysis.
Technical Method Humeral head is resected and canal is created to accept humeral stem component
Target Area Shoulder. Proximal humerus.
Regulation Medical Specialty Orthopedic
Review Panel Orthopedic
Product CodePKC
Premarket Review Office of Orthopedic Devices (OHT6)
Joint Arthroplasty Devices (DHT6A)
Submission Type 510(k)
Regulation Number 888.3660
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? Yes
Life-Sustain/Support Device? No
Recognized Consensus Standards
Third Party Review Not Third Party Eligible