# K083439: Synthes Epoca Shoulder Prosthesis System

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Feb 5, 2009 after 77 days
- Product code: MBF (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3670
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
18 later devices descend from it; 3 cite it directly.
0 of 19 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) Synthes Epoca Shoulder Prosthesis System: named in the summary without a submission number
- (no number) Howmedica Osteonics Solar PureFix HA Shoulder: named in the summary without a submission number

## Most influential descendants
- K170452: Medacta Shoulder System (2017), 12 descendants of its own
- K170910: Medacta Anatomic Shoulder Prosthesis (2017), 8 descendants of its own
- K203108: Ignite Stemless Anatomic Shoulder System (2021), 3 descendants of its own
- K191433: AGILON® XO Shoulder Replacement System (2020), 3 descendants of its own
- K180089: Medacta Shoulder System Short Humeral Diaphysis (2018), 3 descendants of its own

## Indications for use
The 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 glenohumeral joint in the presence of complex fractures (i.e., 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 avascular 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/K083439
Methodology: https://510kreport.com/methodology