# P970015: Inter Fix Threaded Fusion Device

- Pathway: PMA
- Applicant: Sofamor Danek
- Decided: May 14, 1999 after 780 days
- Product code: MAX (Intervertebral Fusion Device With Bone Graft, Lumbar)
- Device class: 2
- Regulation: 21 CFR 888.3080
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1,426 later devices descend from it; 19 cite it directly.
1 of 1,427 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
- K073291: Capstone Spinal System (2008), 1,103 descendants of its own
- K100175: Clydesdale Spinal System (2010), 1,008 descendants of its own
- K080083: Intrepid Spinal System (2008), 932 descendants of its own
- K073109: Stalif TT Intervertebral Body Fusion System (2008), 907 descendants of its own
- K100042: Difusion Technologies Xiphos Interbody Fusion System (2010), 864 descendants of its own

## Recalls of this device
- May 27, 2005 · Not classified · Z-1090-05: The product is labeled as sterile, but this lot was not sterilized.

Source page: https://510kreport.com/device/P970015
Methodology: https://510kreport.com/methodology