Hallu Plates

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

510(k) Number

K021626 ↗

FDA Product Code

HRS

Device Class

Class II

Regulation

21 CFR Part 888.3030

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Solustaple

  Class II

  FDA 510(k) K991566 Active Cleared 3 Aug 1999

• Modification to Ttc Plates

  Class II

  FDA 510(k) K070160 Active Cleared 8 Feb 2007

• Bold Screw

  Class II

  FDA 510(k) K990622 Active Cleared 29 Apr 1999

• The Uni-Clip Staple

  Class II

  FDA 510(k) K011716 Active Cleared 30 Aug 2001

• Kalix II Implant

  Class II

  FDA 510(k) K061765 Active Cleared 18 Jul 2006

• Spin Snap-Off Screw

  Class II

  FDA 510(k) K991477 Active Cleared 14 Jul 1999

See all devices from New Deal, S.A. →

• What is the Hallu Plates device used for?

  The Hallu Plates are orthopedic fixation devices specifically designed for first metatarsophalangeal arthrodesis, a surgical procedure that fuses the joint at the base of the big toe. They provide stable internal fixation to ensure proper alignment and bone union during the healing process, helping patients regain mobility and function after joint fusion.

• Are the Hallu Plates sterile and how are they supplied?

  The Hallu Plates are not described as sterile in the provided data and are supplied as reusable surgical instruments. They are intended for use in orthopedic surgical settings, where they are cleaned and reprocessed according to standard surgical instrument protocols before each procedure.

• What variants of Hallu Plates are available, and how do they differ?

  The Hallu Plates system includes two variants: HALLU-FIX C and HALLU-FIX S. These variants are tailored to specific anatomical requirements, though the exact differences in design or sizing are not detailed in the available records. Both are constructed from titanium and require complementary fixation hardware (e.g., screws) for secure joint stabilization.

• Can Hallu Plates be used with MRI, and what are their storage requirements?

  The provided data does not specify whether Hallu Plates are MRI-safe. As titanium devices, they may pose risks in MRI environments, so clinical teams should verify compatibility with their MRI systems before use. Storage should follow standard orthopedic instrument protocols: clean, dry, and protected from contamination to maintain reusability and integrity.

• What regulatory pathway was followed for the Hallu Plates, and who cleared them?

  The Hallu Plates were cleared via the FDA’s Traditional 510(k) pathway in 2002 under product code HRS (Orthopedic Devices). The clearance was determined to be Substantially Equivalent (SESE) by the Orthopedic (OR) Advisory Committee, with New Deal, S.A. as the applicant. The decision was filed in Potomac, MD, and no third-party review was involved.