TRAUMACEM V+ Injectable Bone Cement

No FDA recalls found in the data synced 25 Oct 2026.

510(k) Number

K170802 ↗

FDA Product Code

LOD

Device Class

Class II

Regulation

21 CFR Part 888.3027

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

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See all devices from Synthes (USA) Products LLC →

• What is the primary clinical use for TRAUMACEM V+?

  This bone cement is specifically indicated for the augmentation of the TFN-ADVANCED Proximal Femoral Nailing System. It is intended for use in patients with poor bone quality to assist in the treatment of osteoporotic fractures.

• How is this bone cement administered?

  The cement is designed to be delivered through cannulated implants and instruments. It is intended for use in combination with internal fixation devices that are specifically designed for PMMA augmentation.

• What is the regulatory status of this device?

  TRAUMACEM V+ Injectable Bone Cement has received FDA 510(k) clearance under K170802. This indicates that the device has been reviewed and found to be substantially equivalent to legally marketed predicate devices.