• 14 Jan 2026
• Admin
• News Article

FDA Expands PearlMatrix Label Across All Major Lumbar Interbody Fusion Approaches

Cerapedics has secured FDA approval to expand the indications for PearlMatrix™ P-15 Peptide Enhanced Bone Graft, its Class III drug-device spinal bone graft.

With this update, PearlMatrix now covers all major lumbar interbody fusion approaches, significantly widening its clinical use.

What Changed With the FDA Approval?

PearlMatrix is now approved for single-level lumbar fusion using:

• ALIF – anterior lumbar interbody fusion
• TLIF – transforaminal lumbar interbody fusion
• PLIF – posterior lumbar interbody fusion
• OLIF/ATP – oblique lumbar interbody fusion
• LLIF – lateral lumbar interbody fusion

The product was previously approved only for TLIF.

Expanded Compatibility With Cage Materials

The FDA also expanded approved cage materials. PearlMatrix can now be used with:

• Titanium alloy cages
• PEEK/titanium cages
• PEEK cages (original approval)

This gives surgeons flexibility across implant preferences and surgical techniques.

Why This Matters Clinically?

Lumbar fusion accounts for nearly two-thirds of all spinal fusion procedures.

With this label expansion:

• More patients can access accelerated fusion
• Surgeons can choose the best interbody approach per patient
• PearlMatrix becomes the only Class III drug-device graft approved across all major lumbar approaches

Clinical Evidence Behind the Expansion

The expansion builds on data from the ASPIRE trial, a pivotal PMA IDE study.

Key ASPIRE outcomes:

• Statistical superiority vs local autograft
• Faster fusion speed
• Comparable safety profile

Results were published in Spine and supported the original FDA approval in June 2025. The FDA approved the expanded label within three months of the supplemental submission.

High-Risk Patients Also Benefited

ASPIRE included patients often excluded from graft studies, such as:

• Type 2 diabetes
• BMI ≥ 30
• Nicotine users

PearlMatrix demonstrated improved time-to-fusion even in these high-risk groups.

How PearlMatrix Works?

PearlMatrix uses P-15 Peptide, a 15-amino-acid sequence found naturally in Type-1 collagen.

Mechanism highlights:

• Promotes osteogenic cell attachment
• Activates natural bone-forming pathways
• Accelerates bone regeneration without exogenous growth factors

The peptide is bound to calcium phosphate, forming a bioactive scaffold.

Bottom Line

PearlMatrix has moved from a single-approach approval to full lumbar coverage.

For surgeons, it means:

• One graft
• Multiple approaches
• Faster fusion backed by Level I clinical evidence

For Cerapedics, this positions PearlMatrix as a category-defining spinal bone graft in the lumbar fusion market.