# K870262: Fenlin II Shoulder Prosthesis

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer, Inc.
- Decided: Apr 3, 1987 after 70 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
No predicates in its family tree.
236 later devices descend from it; 1 cites it directly.
1 of 237 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K982981: New Zimmer Shoulder System (1998), 235 descendants of its own
- K041549: Zimmer Trabecular Metal Humeral Stem (2004), 218 descendants of its own
- K052906: Zimmer Trabecular Metal Reverse Shoulder System (2005), 216 descendants of its own
- K060704: Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MM (2006), 207 descendants of its own
- K063569: Equinoxe Reverse Shoulder System (2007), 190 descendants of its own

Source page: https://510kreport.com/device/K870262
Methodology: https://510kreport.com/methodology