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The HD LifeSciences HiveTM Stand-alone Anterior Lumbar Interbody System is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of non-operative treatment prior to treatment with the devices. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). It is indicated to be used with autograft bone and allograft bone comprised of cancellous and/or corticocancellous bone. These devices are intended to be used with the screws which accompany the implants. When used with the accompanying screws, these devices may be used as stand-alone interbody devices. If the accompanying screws are not used the device is intended for use with supplemental fixation.

Hyperlordotic implants (20° and greater lordosis) must be used with supplemental fixation (e.g. posterior fixation) that are cleared by the FDA for use in the lumbar spine.

The Hive™ Lumbar Interbody Fusion System is FDA cleared under K170676. This submission describes an addition to the Anterior IBFD configurations in which the device in combination with the provided screws would serve as a stand-alone interbody fusion device. This submission adds the Hive™ Stand-alone Anterior Lumbar Interbody System to the previously cleared system, which consists of interbody fusion cages made from Ti-6Al-4V implant-grade titanium conforming to ASTM F3001 using additive manufacturing technology. The implants of the Hive™ Stand-alone Anterior Lumbar Interbody System are offered in a variety of lengths, widths and cross-sectional geometries to accommodate patient anatomy and surgical approach. The implants of the Hive™ Stand-alone Anterior Lumbar Interbody System are also offered in various lordotic configurations to ensure proper stability and alignment of the spine for differing patient anatomy. Implants incorporate features for fixating the device to the vertebral body in a modular stand-alone manner using either interfixated features within the intervertebral space or outer plate fixation on the anterior surface of the vertebral bodies. Inter-fixation and outerfixation allow adjustable placement of fixation components utilizing screws and screw cover plates made from Ti-6A1-4V conforming to ASTM F136.

This document is a 510(k) premarket notification decision letter from the FDA regarding the "Hive™ Stand-alone Anterior Lumbar Interbody System." It is not a document detailing an AI/machine learning device. The core of this submission is about a mechanical interbody fusion device for spine surgery and its substantial equivalence to previously cleared predicate devices based on mechanical and biocompatibility testing.

Therefore, the requested information regarding acceptance criteria, study design for AI devices (sample size, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, training sets, etc.) is not applicable to this document.

The document discusses:

• Device Name: Hive™ Stand-alone Anterior Lumbar Interbody System
• Regulation: 21 CFR 888.3080, Intervertebral Body Fusion Device, Class II
• Indications for Use: Degenerative Disc Disease (DDD) at L2-S1, with or without Grade I spondylolisthesis/retrolisthesis, used with autograft/allograft bone and accompanying screws. Hyperlordotic implants require supplemental fixation.
• Predicate Devices: K170676 (HDLS Lumbar Interbody System), K180814 (M3 Stand-alone Anterior Lumbar System), K180502 (S128 ALIF System), K182195 (Arco-SA Lumbar Cage System).
• Performance Data: This section does not refer to clinical or AI-related performance. Instead, it lists mechanical and biocompatibility tests performed according to ASTM and ISO standards:
  • Static axial compression (ASTM F2077-18)
  • Static compressive shear (ASTM F2077-18)
  • Dynamic axial compression (ASTM F2077-18)
  • Dynamic compressive shear (ASTM F2077-18)
  • Static expulsion (ASTM Draft F-04.25.02.02)
  • Static subsidence (ASTM F2267-04)
  • Screw Pullout (ASTM F543-17)
  • Cytotoxicity (MEM Elution) (ISO 10993-5)
  • Bacterial endotoxins test (ANSI/AAMI ST72:2019)
• Conclusion: The device is substantially equivalent based on overall technology characteristics and mechanical performance data, not clinical data or AI performance.

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