Clinical Foundation
FDA clearance, predicate device history, and Level I evidence supporting the category.
FDA 510(k) Clearance
KeyLift™™ was cleared by the U.S. Food and Drug Administration under 510(k) submission K232484 on October 19, 2023. It is classified as a Class II Spinal Interlaminal Fixation Orthosis under 21 CFR 888.3050, product code PEK. Manufacture is to ASTM F136 (Ti-6Al-4V ELI) and ASTM F138 / A564 stainless steel standards.
| Role | 510(k) Number | Device | Sponsor |
|---|---|---|---|
| Subject device | K232484 | KeyLift™ Interlaminar Fusion System | FloSpine, LLC (now Amplio Spine) |
| Primary predicate | K153302 | Coflex-IF Interlaminar Fusion System | Paradigm Spine, LLC |
| Secondary predicate | K130438 | Axle Interspinous Fusion System | X-spine Systems, Inc. |
Substantial equivalence to Coflex-IF is the regulatory foundation — which means the deep evidence base that Paradigm Spine and Xtant Medical built over a decade is the same evidence base that supports the KeyLift™ category. That’s an unusual asset for a next generation device. The most cited studies are summarized below.
The Level 1 Evidence Base that Supports the Category
Five-year FDA IDE — Interlaminar Stabilization vs. Pedicle Screw Fusion Prospective, randomized, multicenter U.S. IDE trial. 322 patients (215 ILS, 107 fusion) enrolled across 21 sites. Follow-up at 3, 12, 24, 36, 48, and 60 months. 91% follow-up retention at 60 months.
| 5-Year Endpoint | Interlaminar Stabilization | Pedicle Screw Fusion |
|---|---|---|
| Composite Clinical Success (CCS) | 55.1% | 36.4% |
| Patients avoiding re-operation or epidural | 68.8% | 51.3% |
| Secondary surgery rate | 13.0% | 25.7% |
| Follow-up retention at 60 months | 91% | 91% |
ESCADA: Interlaminar Stabilization vs. Decompression Alone
Prospective, randomized, multicenter European trial. 230 patients (115 ILS, 115 decompression alone) enrolled across 7 sites. Follow-up at 3, 12, and 24 months. ILS statistically outperformed decompression-alone on Composite Clinical Success, with increased walking distance, decreased pain medication use, maintained foraminal height, and extended durability of the decompression procedure.
More than a decade of Level 1 data — from the FDA IDE trial of the predicate device and the European ESCADA trial — supports the interlaminar stabilization category as a durable alternative for the appropriate patient. KeyLift™ inherits the regulatory pathway and the underlying clinical narrative of this category, and adds expansion and a dedicated L5–S1 configuration on top.