Natural Lock Acetabular Component

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

510(k) Number

K830662 ↗

FDA Product Code

JDL

Device Class

Class III

Regulation

21 CFR Part 888.3320

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Freeman Hip

  Class II

  FDA 510(k) K852839 Active Cleared 29 Oct 1985

• Total Hip Femoral Component

  Class II

  FDA 510(k) K840150 Active Cleared 27 Feb 1984

• Mark I Total Knee Sys. Arthroplasty

  Class II

  FDA 510(k) K832302 Active Cleared 16 Aug 1983

• Yasargil Fenestrated Aneurysm Clip &

  Class II

  FDA 510(k) K833652 Active Cleared 27 Jan 1984

• PM Cementless Screw-In Acetabular Cup

  Class III

  FDA 510(k) K850773 Active Cleared 2 May 1985

• Cls Hip Prosthesis

  Class II

  FDA 510(k) K852517 Active Cleared 18 Sep 1985

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• Is the Natural Lock Acetabular Component designed for primary or revision hip replacements, and how does its semi-constrained design benefit patients?

  The Natural Lock Acetabular Component is approved for both primary and revision total hip arthroplasty. Its semi-constrained design provides enhanced stability compared to fully unconstrained sockets while still allowing for natural joint motion, which helps reduce dislocation risks in patients with compromised soft tissue support or complex anatomy.

• How is the Natural Lock Acetabular Component sterilized before surgical use, and is it supplied sterile at the time of shipment?

  The device is not sterile at shipment but is sterilized prior to surgical use following standard orthopedic implant protocols. Since it is reusable, sterilization is performed in the surgical setting using validated methods like ethylene oxide or autoclaving, ensuring safety for repeated use.

• Are there multiple sizes or models available for the Natural Lock Acetabular Component, and how does this affect its versatility in surgery?

  While the provided data lists multiple registration numbers and FEI codes (e.g., 3020282716, 1000577893), the exact sizes or models are not specified. However, the presence of numerous registration numbers suggests a range of variants to accommodate different patient anatomies, improving versatility for both primary and revision cases.

• What regulatory pathway was used for FDA clearance, and how does this affect its compliance and use in clinical settings?

  The Natural Lock Acetabular Component received FDA clearance through the Traditional 510(k) pathway (K830662) with a Substantially Equivalent (SESE) decision. This means it was compared to a legally marketed predicate device and deemed equivalent in safety and effectiveness, ensuring compliance with 21 CFR 888.3320 for hip prostheses. Clinically, this clearance confirms its adherence to FDA standards for orthopedic implants.