Founder-led Amplio Spine, LLC enters national commercialization following its asset acquisition of KeyLift® from FloSpine, LLC — an FDA-cleared expandable interlaminar device whose Indications for Use specify plate fixation/attachment to the spinous processes/lamina.

由创始人领导的Amplio Spine, LLC在完成从FloSpine, LLC收购KeyLift®资产后，进入全国商业化阶段。KeyLift®是一款获FDA批准的椎板间扩张装置，其适用范围明确包括对棘突/椎板进行钢板固定/附着。

BOCA RATON, Fla.

佛罗里达州博卡拉顿

,

，

June 18, 2026

2026年6月18日

/PRNewswire/ --

/美通社/ --

Amplio Spine

Amplio脊柱

today announced the close of its asset acquisition of the

今日宣布完成其资产收购

KeyLift® Expandable Interlaminar Stabilization System

KeyLift® 可扩展椎板间稳定系统

(FDA 510(k) K232484) from FloSpine, LLC, and the simultaneous launch of national commercialization. The acquisition transferred the full intellectual property portfolio, 510(k) clearance, finished inventory, and established distributor relationships. Financial terms of the transaction were not disclosed.

来自 FloSpine, LLC 的 FDA 510(k)（编号 K232484）许可，以及同步启动的全国商业化推广。此次收购转移了完整的知识产权组合、510(k) 许可、成品库存以及既有的分销商关系。交易财务条款未予披露。

Amplio Spine is privately held and founder-funded, operating without outside institutional capital..

Amplio Spine 是一家私人控股公司，由创始人出资，不依赖外部机构资本运营。

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Amplio Spine's KeyLift® Expandable Interlaminar Stabilization System

Amplio Spine 的 KeyLift® 可扩展椎板间稳定系统

Speed

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Speed

速度

KeyLift® Expandable Interlaminar Stabilization System

KeyLift® 可扩展椎板间稳定系统

'The surgical world of spine treatment has progressed through the years from what one might describe as maximally invasive to minimally invasive. The KeyLift technology is perhaps among the most secure minimally invasive spinal fusion developments. I believe, when appropriately applied by both well-trained surgeons and interventionalists, it will rise quickly to a preferred technique.'.

脊柱治疗的外科领域多年来已从可称为最大侵入性逐步进展至最小侵入性。KeyLift 技术或许是最安全的微创脊柱融合进展之一。我相信，在训练有素的外科医生和介入医师的恰当应用下，它将迅速成为一种首选技术。

—

—

Stephen H. Hochschuler, MD

斯蒂芬·H·霍赫舒勒，医学博士

, Chairman, Texas Back Institute; Founding Board Member, Global Spine Initiative; Advisory Board Member, Amplio Spine

德克萨斯脊柱研究所主席；全球脊柱倡议创始董事会成员；Amplio Spine 顾问委员会成员

The Device, in FDA Language

用FDA术语描述该设备

Per the FDA-cleared Indications for Use for KeyLift (K232484): the KeyLift Expandable Interlaminar Stabilization System is a posterior, non-pedicle, supplemental fixation device intended for use at a single level in the non-cervical spine (T1–S1). It is intended for plate fixation/attachment to the spinous processes/lamina for the purpose of achieving supplemental fusion in the following conditions: lumbar spinal stenosis, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), and/or tumor.

根据美国食品药品监督管理局（FDA）批准的 KeyLift（K232484）适用范围：KeyLift 可扩展椎板间稳定系统是一种后路、非椎弓根螺钉的辅助固定装置，旨在用于非颈椎节段（T1–S1）的单节段。该装置旨在通过将钢板固定/附着于棘突或椎板上，以在以下情况下实现辅助融合：腰椎管狭窄症、退行性椎间盘疾病（定义为由椎间盘源性引起的背痛，且病史和影像学检查证实存在椎间盘退变）、脊柱滑脱、创伤（即骨折或脱位）和/或肿瘤。

The device is intended for use with allograft or autograft bone and is not intended for stand-alone use..

该设备旨在与同种异体骨或自体骨移植联合使用，不适用于单独使用。

KeyLift is classified by FDA under 21 CFR 888.3050 (Spinal Interlaminal Fixation Orthosis), Class II, product code PEK. Within that classification, KeyLift is distinguished by two attributes: (i) the term 'expandable' appears in its FDA-cleared device name, and (ii) its FDA-cleared Indications for Use specify plate fixation/attachment to the spinous processes/lamina.

KeyLift 被美国食品药品监督管理局（FDA）根据《联邦法规汇编》第21篇第888.3050节（椎板间固定矫形器）归类为第二类医疗器械，产品代码为PEK。在该分类下，KeyLift 具有两个显著特征：(i) 其经FDA批准的器械名称中包含“可扩展”一词；(ii) 其经FDA批准的适用范围明确指定用于棘突/椎板的钢板固定/附着。

Based on Amplio's review of the FDA 510(k) database under product code PEK as of June 2026, no other cleared device in this classification pairs those two attributes. This comparison is based on the FDA-cleared Indications for Use published in each device's 510(k) record, which is the controlling regulatory language; marketing descriptions outside the cleared IFU are not part of this comparison..

根据Amplio截至2026年6月对FDA 510(k)数据库中产品代码为PEK的审查，在该分类中，没有其他已获批准的器械同时具备这两个属性。本比较基于各器械510(k)记录中发布的、经FDA批准的预期用途（Indications for Use），该预期用途是具有约束力的监管性表述；超出已批准预期用途范围的市场宣传描述不纳入本比较。

The Anatomic Rationale

解剖学依据

Posterior spinal fixation has long been pedicle-based, and pedicle-screw constructs remain the standard of care for many indications. In a cadaveric study published in Global Spine Journal, Odeh K, Rosinski A, Leasure J, Kondrashov D, 'Pedicle Screws Challenged: Lumbar Cortical Density and Thickness Are Greater in the Posterior Elements Than in the Pedicles,' Global Spine Journal 2021;11(1):34–43, the authors measured bone mineral density, cortical volume, and cortical thickness across seven anatomical regions of the lumbar vertebrae and reported that the lamina (along with the inferior articular process) exhibited significantly greater cortical thickness and bone mineral density than the pedicles, concluding that the lamina and inferior articular processes 'may offer stronger fixation of the lumbar spine.' KeyLift is designed to seat a plate at the spinous processes/lamina at a single level, consistent with its FDA-cleared Indications for Use..

后路脊柱固定长期以来一直基于椎弓根，而椎弓根螺钉结构仍然是许多适应证的标准治疗方案。在《全球脊柱杂志》（Global Spine Journal）发表的一项尸体研究中，Odeh K、Rosinski A、Leasure J 和 Kondrashov D 在题为“椎弓根螺钉受到挑战：腰椎后部元素的皮质密度和厚度大于椎弓根”（Pedicle Screws Challenged: Lumbar Cortical Density and Thickness Are Greater in the Posterior Elements Than in the Pedicles）的文章中（Global Spine Journal 2021;11(1):34–43），作者测量了腰椎七个解剖区域的骨矿物质密度、皮质体积和皮质厚度，并报告称椎板（连同下关节突）表现出比椎弓根显著更大的皮质厚度和骨矿物质密度，从而得出结论：椎板和下关节突“可能为腰椎提供更强的固定”。KeyLift 旨在将接骨板安置于单一节段的棘突/椎板处，这与其获得美国食品药品监督管理局（FDA） clearance 的适用范围一致。

Two Configurations Under One 510(k)

一个510(k)下的两种配置

The KeyLift platform is commercialized in two configurations cleared under K232484:

KeyLift 平台以两种配置实现商业化，均已通过 K232484 认证：

KeyLiftXL

KeyLiftXL

— sized for the lumbar anatomy.

— 根据腰椎解剖结构定制尺寸。

KeyLiftXS

KeyLiftXS

— a slim-profile configuration sized for the lumbosacral anatomy, including L5–S1, where the interspinous and interlaminar working space is geometrically constrained.

— 一种纤薄轮廓配置，其尺寸适配腰骶部解剖结构（包括L5–S1节段），该区域的棘突间和椎板间工作空间在几何上受到限制。

Across the two configurations, KeyLift ships in eight cleared sizes — four within KeyLiftXL and four within KeyLiftXS — sized for variation in spinous-process and laminar anatomy from the lumbar spine through L5–S1.

在这两种配置中，KeyLift 提供八种已获批的尺寸——KeyLiftXL 和 KeyLiftXS 各四种——以适应从腰椎至 L5–S1 节段棘突和椎板解剖结构的差异。

The Company and the Engineering Lineage

公司与工程传承

Amplio Spine, LLC was founded by Joshua Lambert, a healthcare-industry executive with two decades of leadership across medical-device sales, distribution, and commercial strategy. Amplio acquired the KeyLift platform from FloSpine, LLC, and assumed responsibility for national commercialization, distributor onboarding, and clinical training..

Amplio Spine, LLC 由 Joshua Lambert 创立，他是一位在医疗器械销售、分销和商业战略领域拥有二十年领导经验的医疗保健行业高管。Amplio 从 FloSpine, LLC 收购了 KeyLift 平台，并承担起全国商业化、经销商入驻及临床培训的责任。

KeyLift was developed at FloSpine under the engineering and clinical direction of the late Peter Harris, a long-tenured spine engineer and named inventor on the foundational KeyLift patent family.

KeyLift 是在 FloSpine 开发的，由已故的 Peter Harris 提供工程和临床指导。Peter Harris 是一位资深脊柱工程师，也是 KeyLift 基础专利家族的指定发明人。

Leadership Statement

领导力声明

'KeyLift is cleared by FDA as a posterior, non-pedicle, supplemental fixation device for plate fixation/attachment to the spinous processes/lamina at a single level in the non-cervical spine, T1–S1, for the purpose of achieving supplemental fusion. That is the Indications for Use, and that is the claim we will run on.

KeyLift 已获得美国食品药品监督管理局（FDA）的批准，作为一种后路、非椎弓根、辅助固定装置，用于在非颈椎脊柱（T1–S1）单节段的棘突/椎板上进行钢板固定/连接，以实现辅助融合。这就是其适用范围，也是我们将依据的宣传主张。

The peer-reviewed anatomic record explains why spine specialists may find that target useful; the clinical conclusion belongs to the spine specialists who use it.' — .

“经同行评审的解剖学记录解释了为何脊柱专科医生可能发现该靶点有用；临床结论归属于使用它的脊柱专科医生。” — .

Joshua Lambert

乔舒亚·兰伯特

, Founder & CEO, Amplio Spine, LLC

，Amplio Spine, LLC 创始人兼首席执行官

'Our distributor network is deployed, our field team is trained on the IFU, and our inventory is in market. We are not making noise — we are making cases. Our job is to put the cleared label and the supporting literature in front of the right spine specialists and let procedural experience compound from there.' — .

“我们的分销网络已部署到位，我们的现场团队已接受使用说明书（IFU）的培训，产品库存也已进入市场。我们不高调宣扬，而是专注于实际案例的积累。我们的职责是将获得批准的标签和支持性文献呈现给合适的脊柱专科医生，并让手术操作经验在此基础上不断累积。” — .

Blake Boesel

布莱克·博塞尔

, Chief Revenue Officer and Co-Founder, Amplio Spine, LLC

，首席营收官兼联合创始人，Amplio Spine, LLC

About Amplio Spine, LLC

关于 Amplio Spine, LLC

Amplio Spine, LLC is a founder-led medical-device company headquartered in Boca Raton, Florida, focused on FDA-cleared posterior non-pedicle supplemental fixation. Its lead platform is KeyLift® (FDA 510(k) K232484). More information: ampliospine.com.

Amplio Spine, LLC 是一家由创始人领导的医疗器械公司，总部位于佛罗里达州博卡拉顿，专注于获得美国食品药品监督管理局（FDA）许可的后路非椎弓根辅助固定技术。其核心平台为 KeyLift®（FDA 510(k) K232484）。更多信息请访问：ampliospine.com。

Forward-Looking Statements

前瞻性陈述

This release contains forward-looking statements regarding commercialization, distributor deployment, and clinical adoption. Forward-looking statements are based on current expectations and assumptions and involve known and unknown risks; actual results may differ. They speak only as of the date of this release, and Amplio undertakes no obligation to update them.

本新闻稿包含有关商业化、经销商部署和临床采用的前瞻性陈述。前瞻性陈述基于当前的预期和假设，涉及已知和未知的风险；实际结果可能有所不同。这些陈述仅反映本新闻稿发布之日的情况，Amplio 没有义务对其进行更新。

KeyLift® is a prescription device; refer to the device labeling and Instructions for Use for the full Indications for Use, contraindications, warnings, and precautions..

KeyLift® 是一种处方器械；完整适应症、禁忌症、警告和注意事项请参阅器械标签和使用说明书。

Media Contact

媒体联系人

Amplio Spine, LLC

Amplio Spine, 有限责任公司

[email protected]

[email protected]

ampliospine.com

ampliospine.com

SOURCE Amplio Spine

来源 Amplio Spine

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