FDA.report

Total reverse shoulder prosthesis

Definition
A sterile implantable artificial substitute for a shoulder joint designed to replace both articulating surfaces of the joint particularly in patients with chronic, longstanding rotator cuff muscle tears, arthritis, and/or humeral fractures unsuccessfully treated by previous surgery. The device reverses normal anatomy so that the head portion of the joint is attached to the scapula and the socket portion is attached to the humerus. It typically includes a humeral stem and glenosphere (head) with body and cup components. The device may include screws for implantation and may be implanted with or without bone cement.
GUDID devices
1,226
Last updated
2026-02-25 21:47:34

Related Product Codes

CodeDeviceSpecialtyClassDevices
KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer CementedOrthopedic2576
PHXShoulder Prosthesis, Reverse ConfigurationOrthopedic2474
HSDProsthesis, Shoulder, Hemi-, Humeral, Metallic UncementedOrthopedic2127
HRSPlate, Fixation, BoneOrthopedic236
KWTProsthesis, Shoulder, Non-Constrained, Metal/Polymer CementedOrthopedic226
HWTTemplateOrthopedic110
HWCScrew, Fixation, BoneOrthopedic24
PAOProsthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, CementedOrthopedic24
FZXGuide, Surgical, InstrumentGeneral, Plastic Surgery11
HWAImpactorOrthopedic11
LXHOrthopedic Manual Surgical InstrumentOrthopedic11
MBFProsthesis, Shoulder, Semi-Constrained, Metal/Polymer, UncementedOrthopedic21

Representative GUDID Devices

Primary DIBrandCompanyModelPublished
03700386944871Aequalis™ Ascend™ FlexTORNIERDWF615B2015-10-16
03700386944888Aequalis™ Ascend™ FlexTORNIERDWF615C2015-10-16
03700386944895Aequalis™ Ascend™ FlexTORNIERDWF616A2015-10-16
03700386944901Aequalis™ Ascend™ FlexTORNIERDWF616B2015-10-16
03700386944918Aequalis™ Ascend™ FlexTORNIERDWF616C2015-10-16
03700386944925Aequalis™ Ascend™ FlexTORNIERDWF617A2015-10-16
03700386944932Aequalis™ Ascend™ FlexTORNIERDWF617B2015-10-16
03700386944949Aequalis™ Ascend™ FlexTORNIERDWF617C2015-10-16
03700386944956Aequalis™ Ascend™ FlexTORNIERDWF618A2015-10-16
03700386944963Aequalis™ Ascend™ FlexTORNIERDWF618B2015-10-16
03700386944970Aequalis™ Ascend™ FlexTORNIERDWF618C2015-10-16
03700386945045Aequalis™ Ascend™ FlexTORNIERDWF702A2015-10-16
03700386945052Aequalis™ Ascend™ FlexTORNIERDWF702B2015-10-16
03700386945069Aequalis™ Ascend™ FlexTORNIERDWF702C2015-10-16
03700386945106Aequalis™ Ascend™ FlexTORNIERDWF704A2015-10-16
03700386945113Aequalis™ Ascend™ FlexTORNIERDWF704B2015-10-16
03700386945120Aequalis™ Ascend™ FlexTORNIERDWF704C2015-10-16
03700386945168Aequalis™ Ascend™ FlexTORNIERDWF706A2015-10-16
03700386945175Aequalis™ Ascend™ FlexTORNIERDWF706B2015-10-16
03700386945182Aequalis™ Ascend™ FlexTORNIERDWF706C2015-10-16
03700386945229Aequalis™ Ascend™ FlexTORNIERDWF708A2015-10-16
03700386945236Aequalis™ Ascend™ FlexTORNIERDWF708B2015-10-16
03700386945243Aequalis™ Ascend™ FlexTORNIERDWF708C2015-10-16
03700386916144AEQUALIS REVERSEDTORNIERDWB9352015-10-16
03700386916151AEQUALIS REVERSEDTORNIERDWB9362015-10-16
03700386916618AEQUALIS REVERSEDTORNIERDWD0022015-10-16
03700386916731AEQUALIS REVERSEDTORNIERDWD0692015-10-16
03700386931529AEQUALIS REVERSED ADAPTERTORNIERDWD8632015-10-16
03700386931536AEQUALIS REVERSED ADAPTERTORNIERDWD8642015-10-16
03700386931543AEQUALIS REVERSED ADAPTERTORNIERDWD8652015-10-16
03700386940491FLEX SHOULDER SYSTEMTORNIERDWF361A2015-10-16
03700386940507FLEX SHOULDER SYSTEMTORNIERDWF361B2015-10-16
03700386940514FLEX SHOULDER SYSTEMTORNIERDWF361C2015-10-16
03700386940521FLEX SHOULDER SYSTEMTORNIERDWF362A2015-10-16
03700386940538FLEX SHOULDER SYSTEMTORNIERDWF362B2015-10-16
03700386940545FLEX SHOULDER SYSTEMTORNIERDWF362C2015-10-16
03700386940583FLEX SHOULDER SYSTEMTORNIERDWF364A2015-10-16
03700386940590FLEX SHOULDER SYSTEMTORNIERDWF364B2015-10-16
03700386940606FLEX SHOULDER SYSTEMTORNIERDWF364C2015-10-16
03700386940613FLEX SHOULDER SYSTEMTORNIERDWF365A2015-10-16
03700386940620FLEX SHOULDER SYSTEMTORNIERDWF365B2015-10-16
03700386940637FLEX SHOULDER SYSTEMTORNIERDWF365C2015-10-16
03700386940675Flex Shoulder SystemTORNIERDWF391A2015-10-23
03700386940682Flex Shoulder SystemTORNIERDWF391B2015-10-23
03700386940699Flex Shoulder SystemTORNIERDWF391C2015-10-23
03700386940705Flex Shoulder SystemTORNIERDWF392A2015-10-23
03700386940712Flex Shoulder SystemTORNIERDWF392B2015-10-23
03700386940729Flex Shoulder SystemTORNIERDWF392C2015-10-23
03700386940767Flex Shoulder SystemTORNIERDWF394A2015-10-23
03700386940774Flex Shoulder SystemTORNIERDWF394B2015-10-23
03700386940781Flex Shoulder SystemTORNIERDWF394C2015-10-23
03700386940798Flex Shoulder SystemTORNIERDWF395A2015-10-23
03700386940804Flex Shoulder SystemTORNIERDWF395B2015-10-23
03700386940811Flex Shoulder SystemTORNIERDWF395C2015-10-23
03700386940859FLEX SHOULDER SYSTEMTORNIERDWF421A2015-10-16
03700386940866FLEX SHOULDER SYSTEMTORNIERDWF421B2015-10-16
03700386940873FLEX SHOULDER SYSTEMTORNIERDWF421C2015-10-16
03700386940880FLEX SHOULDER SYSTEMTORNIERDWF422A2015-10-16
03700386940897FLEX SHOULDER SYSTEMTORNIERDWF422B2015-10-16
03700386940903FLEX SHOULDER SYSTEMTORNIERDWF422C2015-10-16
03700386940941FLEX SHOULDER SYSTEMTORNIERDWF424A2015-10-16
03700386940958FLEX SHOULDER SYSTEMTORNIERDWF424B2015-10-16
03700386940965FLEX SHOULDER SYSTEMTORNIERDWF424C2015-10-16
03700386940972FLEX SHOULDER SYSTEMTORNIERDWF425A2015-10-16
03700386940989FLEX SHOULDER SYSTEMTORNIERDWF425B2015-10-16
03700386940996FLEX SHOULDER SYSTEMTORNIERDWF425C2015-10-16
03700386941030FLEX SHOULDER SYSTEMTORNIERDWF5002015-10-16
03700386941054FLEX SHOULDER SYSTEMTORNIERDWF5102015-10-16
03700386941078FLEX SHOULDER SYSTEMTORNIERDWF5202015-10-16
03700386942396FLEX SHOULDER SYSTEMTORNIERDWF5012015-10-16
03700386942402FLEX SHOULDER SYSTEMTORNIERDWF5022015-10-16
03700386942419FLEX SHOULDER SYSTEMTORNIERDWF5112015-10-16
03700386942426FLEX SHOULDER SYSTEMTORNIERDWF5122015-10-16
03700386942433FLEX SHOULDER SYSTEMTORNIERDWF5212015-10-16
03700386942440FLEX SHOULDER SYSTEMTORNIERDWF5222015-10-16
03700386944475Aequalis™ Ascend™ FlexTORNIERDWF601A2015-10-16
03700386944482Aequalis™ Ascend™ FlexTORNIERDWF601B2015-10-16
03700386944499Aequalis™ Ascend™ FlexTORNIERDWF601C2015-10-16
03700386944505Aequalis™ Ascend™ FlexTORNIERDWF602A2015-10-16
03700386944512Aequalis™ Ascend™ FlexTORNIERDWF602B2015-10-16