Amplio Spine closed its asset acquisition of the KeyLift Expandable Interlaminar Stabilization System and launched the product in the U.S. The acquisition transferred the full intellectual property portfolio, 510(k) clearance, finished inventory, and established distributor relationships.
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: the term “expandable” appears in its FDA-cleared device name, and 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.
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.
Amplio Spine closed its asset acquisition of the KeyLift Expandable Interlaminar Stabilization System and launched the product in the U.S. The acquisition transferred the full intellectual property portfolio, 510(k) clearance, finished inventory, and established distributor relationships.
KeyLift is classified by FDA under 21 CFR 888.3050...
Amplio Spine closed its asset acquisition of the KeyLift Expandable Interlaminar Stabilization System and launched the product in the U.S. The acquisition transferred the full intellectual property portfolio, 510(k) clearance, finished inventory, and established distributor relationships.
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: the term “expandable” appears in its FDA-cleared device name, and 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.
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.
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