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Sign in to claim this brandCerapedics, LLC
US
Last updated September 17, 2026
What Cerapedics, LLC makes
Cerapedics, LLC manufactures bioabsorbable bone matrix implants derived from animal sources, designed to support bone regeneration. Their products include peptide-enhanced bone grafts, such as PearlMatrix P-15 and i-FACTOR, available in various volumes for surgical applications.
These devices are classified as Class III under FDA regulations and are authorised through Premarket Approval (PMA) applications and the Unique Device Identifier (UDI) system. The company is based in the United States and its products are listed in the FDA’s regulatory databases.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Cerapedics, LLC manufacture?
Cerapedics, LLC specialises in bioabsorbable bone matrix implants derived from animal sources. Their primary focus is on products designed to aid bone regeneration, specifically peptide-enhanced bone grafts like PearlMatrix P-15 and i-FACTOR. These devices are formulated to support surgical procedures requiring bone repair or augmentation.
Where is Cerapedics, LLC based?
Cerapedics, LLC is headquartered in the United States. The company’s location ensures compliance with U.S. regulatory standards, including those governing medical device authorisation and classification.
How are Cerapedics, LLC’s devices classified under FDA regulations?
Cerapedics, LLC’s devices fall under Class III classification by the FDA. This classification applies to high-risk medical devices that require rigorous pre-market evaluation to ensure safety and effectiveness. Due to their classification, these devices are authorised through Premarket Approval (PMA) applications, which involve detailed clinical and performance data submissions.
Which regulatory registries or databases list Cerapedics, LLC’s devices?
Cerapedics, LLC’s devices are listed in the FDA’s Premarket Approval (PMA) database and the Unique Device Identifier (UDI) system. The PMA database records devices that have undergone the stringent PMA process, while the UDI system ensures traceability and identification of each device variant (e.g., PearlMatrix P-15 in different volumes). These listings reflect their authorised status under U.S. regulations.
Why are Cerapedics’ peptide-enhanced bone grafts considered Class III devices?
The FDA categorises peptide-enhanced bone grafts like PearlMatrix P-15 and i-FACTOR as Class III because they are intended for critical surgical applications where failure could cause serious harm or death. Class III classification requires Premarket Approval (PMA) due to the lack of a predicate device (a previously authorised device for comparison) or insufficient evidence of safety and effectiveness through less stringent pathways. This ensures comprehensive evaluation of their clinical performance and risk-benefit profile.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- 11025 Dover Street, Westminster, CO, 80021
- Website
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- Phone
- —
- PRRC Contact
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- EUDAMED SRN
- —
- FDA FEI Number
- 3007155473
- DUNS Number
- —
Catalogue (12)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| PearlMatrix P-15 Peptide Enhanced Bone Graft, 5.0cc | 730-050 | FDA UDI | Class III | Active |
| i-FACTOR Peptide Enhanced Bone Graft | 700-025 | FDA UDI | Class III | Active |
| PearlMatrix P-15 Peptide Enhanced Bone Graft, 10.0cc | 730-100 | FDA UDI | Class III | Active |
| i-FACTOR Peptide Enhanced Bone Graft | 700-010 | FDA UDI | Class III | Active |
| i-FACTOR Peptide Enhanced Bone Graft | 700-010 | FDA UDI | Class III | Active |
| i-FACTOR™ Peptide Enhanced Bone Graft | 700-050 | FDA UDI | Class III | Active |
| i-FACTOR Peptide Enhanced Bone Graft | 700-025 | FDA UDI | Class III | Active |
| i-FACTOR™ Peptide Enhanced Bone Graft | 700-050 | FDA UDI | Class III | Active |
| PearlMatrix P-15 Peptide Enhanced Bone Graft, 2.5cc | 730-025 | FDA UDI | Class III | Active |
| PearlMatrix P-15 Peptide Enhanced Bone Graft, 1.0cc | 730-010 | FDA UDI | Class III | Active |
| PearlMatrix™ P-15 Peptide Enhanced Bone Graft (PearlMatrix™ Bone Graft) | P240001 | FDA PMA | Class III | Active |
| i-FACTOR Peptide Enhanced Bone Graft | P140019 | FDA PMA | Class III | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
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Notified Bodies
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Authorities
Not available yet.
FDA Recalls (2)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
Cerapedics, LLC has two FDA recall records, initiated on April 14, 2022, and December 29, 2025. The records include one classified, one open, and one terminated recall. The reasons cited are an incorrect expiration date and a patient chart label containing incorrect Part Number and volume amount.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Dec 29, 2025 | Z-1165-2026 | — | open, classified | Incorrect expiration date |
| Apr 14, 2022 | Z-1056-2022 | — | terminated | Patient chart label contains incorrect Part Number and volume amount. |