# K072578: Synthes (Usa) Epoca Shoulder Prosthesis System

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Nov 28, 2007 after 76 days
- Product code: HSD (Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3690
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
24 later devices descend from it; 1 cites it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) ARGOMedical EPOCA Custom Offset Shoulder System: named in the summary without a submission number
- (no number) Tornier Aequalis Shoulder Fracture System: named in the summary without a submission number
- (no number) Aequalis Shoulder System: named in the summary without a submission number

## Most influential descendants
- K091196: GRS Glenoid Resurfacing System (2009), 23 descendants of its own
- K202716: Ignite Anatomic Shoulder System (2021), 13 descendants of its own
- K212737: INHANCE™ Reverse Shoulder System (2022), 9 descendants of its own
- K152825: Catalyst CSR Shoulder System (2016), 7 descendants of its own
- K203108: Ignite Stemless Anatomic Shoulder System (2021), 3 descendants of its own

## Indications for use
Synthes Epoca Shoulder Prosthesis System is intended for use as a hemi or total shoulder replacement. It is a single use device for reconstruction of the glenolmmeral joint in the presence of complex fractures (ie. 3 and 4 part), revision of failed fixation or arthroplasty, post-traumatic mal-union and disabled, painful shoulder joints resulting from various forms of arthropathy such as osteoarthritis, rheumatoid arthritis, traumatic arthritis or avasoular necrosis and other pathologies where arthrodesis is not acceptable. The Press-fit Titanium Plasma Sprayed Humeral Stems are for cementless use only.

Source page: https://510kreport.com/device/K072578
Methodology: https://510kreport.com/methodology