# K170802: TRAUMACEM™ V+ Injectable Bone Cement

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (USA) Products, LLC
- Decided: Sep 28, 2017 after 195 days
- Product code: LOD (Bone Cement)
- Device class: 2
- Regulation: 21 CFR 888.3027
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K062553 (2007). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062553: Simplex P Bone Cement, Stryker Orthopaedics (2007) Summary page 4.

## Indications for use
The TRAUMACEM™ V+ Injectable Bone Cement is indicated for augmentation of the TFN-ADVANCED® Proximal Femoral Nailing System through cannulated implants and instruments for patients with poor bone quality (e.g., osteoporosis).

Source page: https://510kreport.com/device/K170802
Methodology: https://510kreport.com/methodology