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Allofix Push-In Anchor

FDA 510(k)

Class II (US FDA 510(k))

510(k) K070347

by Musculoskeletal Transplant Foundation

Identifiers

510(k) Number
K070347 FDA 510(k)
FDA Product Code
HWC FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 888.3040 FDA 510(k)
Regulation Number
888.3040 FDA 510(k)
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Allofix Push-In Anchor is a bone fixation device classified under orthopedic implants, designed for securing soft tissue to bone. Constructed from machined human allograft bone sourced from the tibia or femur of deceased donors, it provides a biological alternative for anchoring applications. Its push-in mechanism facilitates easy insertion into bone without the need for additional fixation tools beyond the included insertion device. The device is intended for use in orthopedic procedures requiring stable soft tissue-to-bone attachment.

The Allofix Push-In Anchor is supplied as a single-use, non-sterile device and requires terminal sterilization prior to implantation. It is intended for use in an operating room setting and must be handled under aseptic conditions. The device is regulated under 21 CFR 888.3040 and holds an FDA 510(k) clearance (K070347) as substantially equivalent to a predicate device. No specific MRI safety information is provided, and its dimensions or sizing are not detailed in the available data.

Frequently asked questions

What is the Allofix Push-In Anchor used for?

The Allofix Push-In Anchor is designed to secure soft tissue to bone in orthopedic procedures where stable attachment is required. Its biological composition—made from machined human allograft bone—provides an alternative to synthetic anchors, integrating with natural tissue to support healing and fixation.

How is the Allofix Push-In Anchor supplied and prepared for use?

The device is supplied as a single-use, non-sterile item. Terminal sterilization must be performed prior to implantation to ensure sterility. It is intended for use in an operating room under aseptic conditions, and the included insertion device facilitates easy push-in placement without additional tools.

Is the Allofix Push-In Anchor reusable or intended for single use?

The Allofix Push-In Anchor is explicitly designed for single-use only. Its biological composition and terminal sterilization requirement preclude reuse, as repeated sterilization could compromise structural integrity or biological properties.

What materials is the Allofix Push-In Anchor made from?

The anchor is constructed from machined human allograft bone sourced from the tibia or femur of deceased donors. This biological material offers a natural alternative to synthetic implants, aiming to integrate with surrounding tissue for enhanced fixation stability.

Are there any specific storage or handling instructions for the Allofix Push-In Anchor?

While exact storage details are not specified, the device must be handled under aseptic conditions due to its non-sterile supply. Terminal sterilization is mandatory before use, and the allograft material should be stored according to standard biological implant protocols to preserve integrity until sterilization.

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: PDF VI. 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS, ALLOFIX PUSH-IN ANCHOR (K070347) — FDA 510(k) | Innolitics, PDF VI. 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Musculoskeletal Transplant Foundation

Sources (1)

  • FDA 510(k) K070347 24 fields · synced Oct 5, 2026