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Osteophil Beta-TCP

FDA 510(k)

Class II (US FDA 510(k))

510(k) K102937

by Cytophil, Inc.

Identifiers

510(k) Number
K102937 FDA 510(k)
FDA Product Code
MQV 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)

Osteophil Beta-TCP is a porous, synthetic, resorbable bone void filler classified as a bone graft substitute. It is composed of beta-Tricalcium Phosphate (B-TCP) and designed to mimic the structure of human cancellous bone through a multidirectional interconnected porosity. This device is intended for filling bony defects in orthopedic applications, including the extremities, posterolateral spine, and pelvis. Its primary function is to provide structural support and promote bone regeneration in surgical sites.

The device is supplied as granules in sizes ranging from 1 mm to 4 mm and is implanted directly by surgeons into the target defect site. Osteophil Beta-TCP is a single-use, non-sterile product, as indicated by its FDA 510(k) clearance (K102937) under product code MQV. It is regulated as a Class II medical device under the Orthopedic advisory committee and is intended for use in orthopedic procedures. Storage and handling must comply with standard medical device protocols for bone graft substitutes.

Frequently asked questions

What is Osteophil Beta-TCP used for?

Osteophil Beta-TCP is a synthetic bone void filler designed to fill bony defects in orthopedic procedures. Its porous structure mimics cancellous bone, providing structural support while promoting bone regeneration in areas such as the extremities, posterolateral spine, and pelvis. It is specifically intended for surgical sites where bone volume needs to be restored or maintained.

How is Osteophil Beta-TCP supplied and prepared for use?

The device is supplied as granules in sizes ranging from 1 mm to 4 mm. It is implanted directly into the target defect site by surgeons during orthopedic procedures. No additional preparation is required beyond standard surgical protocols for bone graft substitutes, as it is intended for direct implantation.

Is Osteophil Beta-TCP sterile and reusable?

Osteophil Beta-TCP is a non-sterile and single-use product. Sterility is not required for this classification under FDA 510(k) clearance (K102937), and reuse is not recommended or supported by the manufacturer. Always follow standard medical device handling protocols to ensure surgical site integrity.

What storage requirements apply to Osteophil Beta-TCP?

Storage must comply with standard medical device protocols for bone graft substitutes. Since it is non-sterile, it should be kept in a clean, dry environment away from direct sunlight or extreme temperatures. Ensure the packaging remains intact until immediate use to prevent contamination or degradation of the granules.

What regulatory pathway does Osteophil Beta-TCP follow?

Osteophil Beta-TCP is classified as a Class II medical device under the FDA’s Orthopedic advisory committee (OR). It received 510(k) clearance (K102937) via a traditional review process, demonstrating substantial equivalence to a predicate device. The product code assigned is MQV, indicating its classification as a bone graft substitute.

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: OSTEOPHIL BETA-TCP (K102937) — FDA 510 (k) | Innolitics, Osteophil Beta-TCP - Cytophil | FDA Evidence Review, OSTEOPHIL BETA-TCP 510 (k) K102937 - FDA.report

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Cytophil, Inc.

Sources (1)

  • FDA 510(k) K102937 24 fields · synced Oct 1, 2026