# K161114: HIGH V+

- Pathway: 510(k) (Traditional)
- Applicant: Teknimed Sas
- Decided: Apr 12, 2017 after 357 days
- Product code: NDN (Cement, Bone, Vertebroplasty)
- Device class: 2
- Regulation: 21 CFR 888.3027
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K032945 (2004). 2 ancestors in all.
42 later devices descend from it; 2 cite it directly.
0 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090435: Vertecem, Teknimed, S.A. (2009) Summary page 4.
- K032945: Simplex X, Stryker Corp. (2004) Summary page 4.

## Most influential descendants
- K180498: NuVasive Reline Fenestrated Screws, High V+ Bone Cement (2018), 41 descendants of its own
- K190526: High V+ Bone Cement, CarboClear® Fenestrated Pedicle Screws (2019), 28 descendants of its own
- K200596: G21 Cement, VADER® Pedicle System (2020), 27 descendants of its own
- K221926: Invictus® Bone Cement, Invictus Spinal Fixation System (2022), 14 descendants of its own
- K232275: Invictus® Spinal Fixation System (2023), 11 descendants of its own

## Recalls of this device
- Dec 15, 2022 · Class II · Z-1099-2023: Incorrect expiry date. Product is labeled with expiry date 2027-02-28. The correct expiration date is 2025-02-28.

## Indications for use
The HIGH V+ is used for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures of the vertebral body may result from osteoporosis, benign lesions (hemangioma), or malignant lesions (metastatic cancers, myeloma).

Source page: https://510kreport.com/device/K161114
Methodology: https://510kreport.com/methodology