K-number	K251896
Device name	XeliteMed SuperM-Fix Spinal Bone Cement
Applicant	Xelite Biomed , Ltd.
Product code	NDN
Device class	Class II
Decision date	Jan 28, 2026
Decision	Substantially Equivalent
Regulation	888.3027

AI Summary extracted from FDA summary PDF · never regenerated

Intended use

XeliteMed SuperM-Fix Spinal Bone Cement is a two-component PMMA bone cement system (powder and liquid) used to treat pathological vertebral fractures via vertebroplasty or kyphoplasty procedures. It is indicated for fractures caused by osteoporosis, benign tumors such as hemangioma, or malignancies including metastatic cancer and myeloma.

Technological characteristics

The subject device differs from the predicate in that it includes hydroxyapatite as an additional radiopacifier alongside barium sulphate, whereas the predicate uses only barium sulphate. Both devices use identical PMMA-styrene copolymer, identical initiators and promoters, identical sterilization methods (EtO gas for powder, filtration for liquid), and identical manual mixing and application methods.

Test standards cited

Testing referenced ISO 10993-1 for biocompatibility. The document cites compliance with a Special Controls Guidance document but does not identify specific consensus standards (ASTM, IEC, ISO) by number for performance testing.

Extracted by AI from the official FDA summary PDF →

Source

View the full FDA submission: accessdata.fda.gov

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XeliteMed SuperM-Fix Spinal Bone Cement

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