Lactosorb 5.0 mm Washer
FDA 510(k)Class II (US FDA 510(k))
by Biomet, Inc.
Identifiers
- 510(k) Number
- K001581 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 Lactosorb 5.0 mm Washer is a smooth or threaded metallic bone fixation fastener, classified under product code HWC. Designed for orthopedic use, this device is intended for implantation to provide structural support and stability to bone, often in conjunction with other fixation hardware. Constructed from biocompatible alloys such as cobalt-chromium-molybdenum or stainless steel, it is engineered to integrate with bone tissue while maintaining mechanical integrity.
This device is supplied as a single-use, sterile item and is intended for use in orthopedic surgical procedures. The 5.0 mm diameter washer is part of a resorbable fixation system, allowing for gradual absorption by the body over time. It is regulated under FDA 510(k) clearance (K001581) and falls under the Orthopedic Advisory Committee’s purview. Storage and handling must adhere to sterile medical device protocols to ensure integrity prior to surgical use.
Frequently asked questions
What is the Lactosorb 5.0 mm Washer used for?
The Lactosorb 5.0 mm Washer is designed for orthopedic surgical procedures to provide structural support and stability to bone. It is typically used in conjunction with other fixation hardware to ensure proper alignment and healing, particularly in scenarios requiring gradual absorption by the body over time.
Is the Lactosorb 5.0 mm Washer single-use or reusable?
The Lactosorb 5.0 mm Washer is intended for single-use only. As a sterile medical device, it must remain unopened and unused until the time of surgery to maintain its sterility and integrity.
What materials is the Lactosorb 5.0 mm Washer made from?
The device is constructed from biocompatible alloys, specifically cobalt-chromium-molybdenum or stainless steel. These materials are chosen for their ability to integrate with bone tissue while maintaining mechanical stability during implantation.
How should the Lactosorb 5.0 mm Washer be stored?
The Lactosorb 5.0 mm Washer must be stored according to sterile medical device protocols to preserve its integrity. This includes keeping it in its original packaging, in a clean, dry environment, and away from direct sunlight or extreme temperatures until ready for surgical use.
What distinguishes the Lactosorb 5.0 mm Washer from other bone fixation washers?
The Lactosorb 5.0 mm Washer is part of a resorbable fixation system, meaning it gradually absorbs into the body over time, unlike permanent fixation devices. Its 5.0 mm diameter and biocompatible alloy construction (cobalt-chromium-molybdenum or stainless steel) are key distinguishing features for orthopedic applications requiring temporary support.
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: LACTOSORB 5.0 MM WASHER (K001581) - FDA 510 (k), LACTOSORB 5.0 MM WASHER (K001581) — FDA 510 (k) | Innolitics, LACTOSORB 5.0 MM WASHER by BIOMET, INC. | FDA 510 (k) Summary
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K001581 | Class II | Active |
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Manufacturer
- Manufacturer
- Biomet, Inc.
Sources (1)
- FDA 510(k) K001581 24 fields · synced Oct 1, 2026