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U.S. Department of Health and Human Services

Product Classification

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Device shoulder prosthesis, reverse configuration
Regulation Description Shoulder joint metal/polymer semi-constrained cemented prosthesis.
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.
Physical State Typically includes humeral stem, humeral socket, humeral cup, glenosphere, and glenoid baseplate with fixation screws. The humeral stem and humeral socket may be one single piece or two separate pieces locked together. The humeral cup is snap fit into the humeral socket. The humeral cup is made from UHMWPE and articulates with the glenosphere made of CoCrMo alloy, Titanium alloy, or stainless steel. The glenosphere locks to glenoid baseplate which is fixed to the glenoid bone by 2-6 screws. The glenoid baseplate has HA coating, metallic coating or no coating and may feature a central peg, central screw, central cage, or keel.
Technical Method Relative to the native shoulder joint, the device moves the center of rotation medially and distally to the anatomic position which increases the length of the deltoid muscle's lever arm, allowing the same rotational moment with less applied force.
Target Area Shoulder joint
Regulation Medical Specialty Orthopedic
Review Panel Orthopedic
Product CodePHX
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