Synthetic Bone Graft (TriPore HA +2 more)
FDA 510(k)Class II (US FDA 510(k))
by Orthogem Ltd
Identifiers
- 510(k) Number
- K150064 FDA 510(k)
- FDA Product Code
- MQV FDA 510(k)
- Models / Variants
- TriPore HA FDA 510(k)TriPore BP90 FDA 510(k)TriPore BP15 FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3045 FDA 510(k)
- Regulation Number
- 888.3045 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Synthetic Bone Graft TriPore HA, TriPore BP90, and TriPore BP15 is a synthetic, porous bone void filler composed of calcium compounds. It is intended to be packed into surgically created voids or bone defects resulting from traumatic injury in the skeletal system, including the extremities, posterolateral spine, or pelvis. The device is designed to gradually resorb and be replaced by natural bone in areas that are not intrinsic to the stability of the bony structure.
This device is identified by K-number K150064 and has received FDA 510(k) clearance. It is categorized under the orthopedic medical specialty for use as a bone void filler. Users should refer to the specific product labeling for information regarding storage, sterility, and application requirements.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Synthetic Bone Graft (TriPore HA, TriPore BP90, TriPore BP15), Synthetic Bone Graft (TriPore HA, TriPore BP90… - FDA.report, TRIPORE, MODELS HA, BP90, BP15 (K070132) — FDA 510(k) | Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K150064 | Class II | Active |
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Manufacturer
- Manufacturer
- Orthogem Ltd
- FDA Applicant
- Orthogem, Ltd.
Sources (1)
- FDA 510(k) K150064 24 fields · synced Sep 24, 2026