L.M.S. Self-Detachable Broach With Stop

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K901273 ↗

FDA Product Code

HTY

Device Class

Class II

Regulation

21 CFR Part 888.3040

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K901626 Active Cleared 14 Aug 1990

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• What types of orthopedic procedures is this broach designed for, and how does the self-detachable feature benefit the surgeon?

  The L.M.S. Self-Detachable Broach With Stop is specifically designed for bone broaching procedures, commonly used in orthopedic surgeries like intramedullary nailing or bone grafting. The self-detachable mechanism allows the broach to separate cleanly from the handle once fully inserted, reducing the risk of accidental detachment during use. This feature enhances precision and control, ensuring the broach reaches the correct depth as guided by the integrated stop, which helps prevent over-penetration or improper placement.

• Is this broach intended for reuse, or is it meant to be used only once? How should it be stored to maintain sterility?

  The L.M.S. Self-Detachable Broach With Stop is explicitly designed for single-use only. To preserve sterility before surgery, it must be stored and handled according to standard sterile instrument protocols—typically in a sealed, sterile packaging until the moment of use. Reusing it could compromise patient safety and device integrity, so adherence to single-use guidelines is critical.

• What regulatory pathway was followed for FDA clearance, and what does the product code (HTY) indicate about its classification?

  The device received FDA clearance through the Traditional 510(k) review pathway under the classification HTY, which falls under the Orthopedic category. The product code (HTY) signifies it is classified as an orthopedic surgical instrument, confirming its intended use in bone-related procedures. The clearance (K901273) was granted in 1990, demonstrating its long-standing regulatory approval for these applications.

• How does the integrated stop on this broach contribute to the precision of bone broaching?

  The integrated stop on the L.M.S. Self-Detachable Broach With Stop acts as a depth-limiting feature, ensuring the broach is inserted to the correct depth during surgery. This prevents over-penetration into the bone, which could cause damage or complications. By providing a tactile and visual reference, the stop enhances surgical precision, particularly in procedures like intramedullary nailing where accurate placement is critical for proper alignment and stability.