# P950019: Ray Threaded Fusion Cage (TFC)(TM) with Instrumentation

- Pathway: PMA
- Applicant: Stryker Spine
- Decided: Oct 29, 1996 after 503 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.
1,482 later devices descend from it; 38 cite it directly.
1 of 1,483 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
- 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
- K100175: Clydesdale Spinal System (2010), 1,008 descendants of its own
- K080083: Intrepid Spinal System (2008), 932 descendants of its own

## Recalls of this device
- Aug 18, 2008 · Not classified · Z-0151-2009: The label on one side on the Ray TFC Device (Ray Cage) is incorrect. It reads 20 mm x 26 mm instead of 20 mm x 21 mm.

Source page: https://510kreport.com/device/P950019
Methodology: https://510kreport.com/methodology