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U.S. Department of Health and Human Services

Product Classification

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Device prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented
Regulation Description Shoulder joint metal/polymer semi-constrained cemented prosthesis.
Definition Total shoulders are indicated for arthritis (osteo-, rheumatoid, traumatic), avascular necrosis, correction of functional deformity, and revision procedures.
Physical State May include: Humeral stem Humeral neck Humeral tray Glenoid component Glenoid tray Glenosphere Fixation screws Instrumentation
Technical Method To be implanted to replace a shoulder joint. It limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across the joint. This generic type of device includes prosthesis that have a muheral component mode of alloys, such as CoCr or Ti alloys, and and a glenoid components made of ultra-high molecular weight polyethylene plus an additive, such as á-tocopherol. Reverse shoulder have a glenosphere made from CoCr and a humeral tray made from ultra-high molecular weight polyethylene plus an additive. The tray attaches to a metallic humeral stem.
Target Area Shoulder
Regulation Medical Specialty Orthopedic
Review Panel Orthopedic
Product CodePAO
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