Hammerloc Tibial Fixation Device
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K103145 FDA 510(k)
- FDA Product Code
- MBI 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 Hammerloc Tibial Fixation Device is a smooth or threaded metallic bone fixation fastener, classified under 21 CFR 888.3040. It is designed for orthopedic applications, providing secure fixation to the tibia, a common requirement in procedures involving ligament reconstruction or bone stabilization.
This device is supplied sterile and intended for single-use. It is regulated under FDA 510(k) clearance (K103145) with a traditional review process, classified as substantially equivalent to predicate devices. The product code MBI categorizes it within orthopedic fixation hardware, adhering to MRI safety standards for metallic implants. Storage and handling follow standard sterile medical device protocols.
Frequently asked questions
What types of procedures is the Hammerloc Tibial Fixation Device commonly used for, and why is it designed this way?
The Hammerloc Tibial Fixation Device is primarily used in orthopedic procedures involving ligament reconstruction or bone stabilization of the tibia. It is designed as a smooth or threaded metallic fastener to provide secure fixation, ensuring stability during the healing process of soft tissue grafts or bone fragments. The threaded option enhances grip in certain bone densities, while the smooth variant offers versatility for less demanding applications.
Is the Hammerloc Tibial Fixation Device reusable, or is it intended for single-use only? How does this affect its sterility?
The Hammerloc Tibial Fixation Device is explicitly intended for single-use only. This design choice ensures patient safety by eliminating the risk of cross-contamination, which is why it is supplied sterile from the manufacturer. Single-use devices also reduce the need for reprocessing, maintaining consistent performance and sterility standards.
What storage and handling precautions should be taken with the Hammerloc Tibial Fixation Device to maintain its integrity?
The Hammerloc Tibial Fixation Device follows standard sterile medical device protocols for storage and handling. It should be kept in its original, sealed packaging until immediately before use to preserve sterility. Storage should occur in a clean, dry environment away from direct sunlight or extreme temperatures, as recommended for metallic orthopedic implants. Always follow manufacturer instructions for unpacking and preparation to avoid contamination.
Are there different sizes or models of the Hammerloc Tibial Fixation Device, and if so, how are they distinguished?
The provided data does not specify distinct sizes or model variants of the Hammerloc Tibial Fixation Device. However, as a metallic fixation fastener for the tibia, it is likely available in standard lengths and diameters to accommodate different patient anatomies or clinical needs. For precise sizing details, refer to the manufacturer’s product catalog or technical documentation, as these are not explicitly outlined in the regulatory submission.
How was the Hammerloc Tibial Fixation Device approved by the FDA, and what does its product code (MBI) indicate?
The Hammerloc Tibial Fixation Device received FDA 510(k) clearance (K103145) through a traditional review process, meaning it was deemed substantially equivalent to a predicate device already on the market. The product code MBI categorizes it under orthopedic fixation hardware, confirming its classification under 21 CFR 888.3040. This classification also implies compliance with MRI safety standards for metallic implants, as required for such devices.
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: HAMMERLOC TM TIBIAL FIXATION DEVICE - Innolitics, Hammerloc Tm Tibial Fixation Device - Beudamed, Sports Medicine Products from Zimmer Biomet
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K103145 | Class II | Active |
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Manufacturer
- Manufacturer
- Biomet Sports Medicine
Sources (1)
- FDA 510(k) K103145 24 fields · synced Oct 6, 2026