# K980244: Aequalis Shoulder Prosthesis

- Pathway: 510(k) (Traditional)
- Applicant: Tornier
- Decided: Aug 23, 1999 after 577 days
- Product code: KWS (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K790987 (1979). 3 ancestors in all.
160 later devices descend from it; 3 cite it directly.
0 of 164 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K952928: Aequalis Shoulder System for Total & Hemishoulder Applications, Tornier (1995) Summary page 2.
- K872454: Biomet Modular Shoulder Prosthesis, Biomet, Inc. (1987) Summary page 2.
- K790987: Zimmer R Total Shoulder II, Zimmer, Inc. (1979) Summary page 2.

## Most influential descendants
- K102924: Aequalis Ascend Modular Anatomic Shoulder System (2011), 110 descendants of its own
- K110599: Aequalis Ascend Modular Reverse Shoulder System (2011), 108 descendants of its own
- K112615: Aequalis Ascend Modular Reverse Shoulder System (2011), 97 descendants of its own
- K122698: Aequalis Ascend Flex Shoulder System (2013), 96 descendants of its own
- K042021: Exactech Equinoxe Shoulder System (2004), 71 descendants of its own

## Indications for use
Primary, secondary or post-traumatic osteoarthritis, rheumatoid arthritis, severe joint pain of osteoarticular origin compromising the patients quality of life, joints which are defective in shape and function, a revision intervention on a previous arthroplasty, and other disorders in which arthrodesis is not an acceptable option.

Source page: https://510kreport.com/device/K980244
Methodology: https://510kreport.com/methodology