Amplio Spine Acquires and Commercializes KeyLift®, an FDA-Cleared Expandable Interlaminar Stabilization System Indicated for Supplemental Fusion of the Non-Cervical Spine

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.

BOCA RATON, Fla., June 18, 2026 /PRNewswire/ -- Amplio Spine today announced the close of its asset acquisition of the KeyLift® Expandable Interlaminar Stabilization System (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. Amplio Spine is privately held and founder-funded, operating without outside institutional capital.

"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."

— Stephen H. Hochschuler, MD , Chairman, Texas Back Institute; Founding Board Member, Global Spine Initiative; Advisory Board Member, Amplio Spine

The Device, in FDA Language

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

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. 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.

The Anatomic Rationale

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.

Two Configurations Under One 510(k)

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

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

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.

The Company and the Engineering Lineage

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.

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.

Leadership Statement

"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. 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." — Joshua Lambert, Founder & CEO, Amplio Spine, LLC

"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." — Blake Boesel, Chief Revenue Officer and Co-Founder, Amplio Spine, LLC

About 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.

Forward-Looking Statements

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

Media Contact
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SOURCE Amplio Spine