# K011037: Vertebral Spacer

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Jul 1, 2002 after 452 days
- Product code: MQP (Spinal Vertebral Body Replacement Device)
- Device class: 2
- Regulation: 21 CFR 888.3060
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1,374 later devices descend from it; 11 cite it directly.
2 of 1,375 devices in its family (counting itself) have 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
- K062083: Synfix -LR (2007), 1,252 descendants of its own
- K072253: Synfix-LR Spacer (2007), 1,250 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
- K080083: Intrepid Spinal System (2008), 932 descendants of its own

Source page: https://510kreport.com/device/K011037
Methodology: https://510kreport.com/methodology