# P950002: Bak Interbody Fusion System

- Pathway: PMA
- Applicant: Zimmer Spine, Inc.
- Decided: Sep 20, 1996 after 612 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.
1,681 later devices descend from it; 35 cite it directly.
2 of 1,682 devices in its family (counting itself) have 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
- K072120: Paramount Intervertebral Body Fusion Device (2007), 1,405 descendants of its own
- K072253: Synfix-LR Spacer (2007), 1,250 descendants of its own
- K073291: Capstone Spinal System (2008), 1,103 descendants of its own
- K073470: Avs PL Peek Spacers, Models 48351XXX and 48353XXX (2008), 1,102 descendants of its own
- K080758: Avs PL Peek Spacers, Models 48351 and 48353 (2008), 1,091 descendants of its own

Source page: https://510kreport.com/device/P950002
Methodology: https://510kreport.com/methodology