# P000028: Affinity (TM) Cage System

- Pathway: PMA
- Applicant: Medtronic Sofamor Danek USA, Inc.
- Decided: Jun 13, 2002 after 702 days
- Product code: MAX (Intervertebral Fusion Device With Bone Graft, Lumbar)
- Device class: 2
- Regulation: 21 CFR 888.3080
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1,287 later devices descend from it; 16 cite it directly.
1 of 1,288 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Most influential descendants
- K073320: Cimplicity Spinal System (2008), 1,018 descendants of its own
- K081917: Depuy Spine Bengal, Concorde, Cougar, Devex and Leopard Systems (2009), 1,008 descendants of its own
- K072415: Stalif (TM) C (2008), 948 descendants of its own
- K073109: Stalif TT Intervertebral Body Fusion System (2008), 907 descendants of its own
- K091088: LDR Spine Cervical Interbody Fusion System (2009), 901 descendants of its own

Source page: https://510kreport.com/device/P000028
Methodology: https://510kreport.com/methodology