# K091946: Vlift-S Vertebral Body Replacement System, Models 488812XX, 488814XX, 488816XX, 488818XX

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Spine
- Decided: Sep 25, 2009 after 87 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
Longest line of descent: 9 generations back to K003155 (2001). 27 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060506: Stryker Spine Vlift Vertebral Body Replacement System, Stryker Spine (2006) Summary page 1.
- K080568: X-Mesh Expandable Cage System, Depuy Spine, Inc. (2008) Summary page 1.
- K061891: Synex II, Synthes Spine Co.Lp (2006) Summary page 1.
- K003709: Surgical Dynamics Mesh Cage System, United States Surgical, A Division of Tyco Healthc (2001) Summary page 1.
- K003043: Surgical Titanium Mesh System, Depuyacromed (2001) Summary page 1.

## Most influential descendants
- K183071: VLIFT-s Vertebral Body Replacement System (2019), 4 descendants of its own
- K241468: Vertiwedge® Intraosseous System (2024), 1 descendant of its own
- K221490: Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior Lumbar Cage, Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved Posterior Lumbar Cage, Stryker Spine VLIFT Vertebral Body Replacement System, VLIFT-s Vertebral Body Replacement System, Ascential IBD PEEKc Spacer, Aero-AL Lumbar Cage System, Aero-LL Lumbar Cage System, Aero-C Cervical Cage System, AVS Aria PEEK Spacer, AVS Anchor-C Cervical Cage System, AVS Anchor-L Spacer (2023), 1 descendant of its own
- K261810: Vertiwedge® Intraosseous System (2026), 0 descendants of its own
- K262061: Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior Lumbar Cage; Aero® -C Cervical Cage System; AVS® Anchor-C Cervical Cage System; AVS® TL PEEK Spacer; AVS® PL PEEK Spacers; AVS® Navigator PEEK Spacer; AVS® AS PEEK Spacer; Monterey™ AL Interbody System; Aleutian IBF System; Cascadia Interbody System; Chesapeake Stabilization System; Sahara Stabilization System; SANTORINI™ Corpectomy Cage System; MOJAVE Interbody System; VLIFT VERTEBRAL BODY REPLACEM (2026), 0 descendants of its own

## Indications for use
The VLIFT6-s system is a device intended to replace a vertebral body or an entire vertebra. It is for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body or vertebra resected or excised during total and partial corpectomy and vertebrectomy procedures due to tumor or trauma (i.e., fracture). For both corpectomy and vertebrectomy procedures, VLIFT0-s system is intended to be used with supplemental internal fixation systems. The supplemental internal fixation systems that may be used with VLIFT-s system include, but are not limited to, Stryker Spine plate or rod systems (e.g., Xia® Spinal System, Radius ® Spinal System, Mantis ® Percutaneous Spinal System, Thor® Plating System, Trio®+Spinal System). The use of bone graft with VLIFIT--s system is optional.

Source page: https://510kreport.com/device/K091946
Methodology: https://510kreport.com/methodology