Sizing & Specifications
Two Platforms. Eight Sizes. One Reproducible Technique.
KeyLift™ is available in two platforms — XL and XS — with a total of eight implant SKUs and two paired clamps, covering the non-cervical spine from T1 through S1. Both platforms share the same surgical technique and the same 4 mm in-situ distraction mechanism, so adopting one means the workflow translates directly to the other.
Platform Comparison
| | KeyLift™ XL | KeyLift™ XS |
|---|---|---|
| Anatomic level | T1–L5 (thoraco-lumbar) | L5–S1 (lumbosacral) |
| Footprint | 20 mm | 18 mm |
| In-situ distraction | 4 mm | 4 mm |
| Implant heights | 10, 12, 14, 16 mm | 10, 12, 14, 16 mm |
| Paired clamp | 07-1000-010 | 07-1000-110 |
| FDA clearance | K232484 | K232484 |
KeyLift™ XL — Thoraco-Lumbar (T1–L5)
| SKU | Description | Footprint | Implant Height |
|---|---|---|---|
| 07-1220-010 | KeyLift™ XL | 20 mm | 10 mm (expands~14 mm) |
| 07-1220-012 | KeyLift™ XL | 20 mm | 12 mm (expands~16 mm) |
| 07-1220-014 | KeyLift™ XL | 20 mm | 14 mm (expands~18 mm) |
| 07-1220-016 | KeyLift™ XL | 20 mm | 16 mm (expands~20 mm) |
KeyLift™ XS — Lumbosacral (L5–S1)
| SKU | Description | Footprint | Implant Height |
|---|---|---|---|
| 07-1218-110 | KeyLift™ XS | 18 mm | 10 mm (expands~14 mm) |
| 07-1218-112 | KeyLift™ XS | 18 mm | 12 mm (expands~16 mm) |
| 07-1218-114 | KeyLift™ XS | 18 mm | 14 mm (expands~18 mm) |
| 07-1218-116 | KeyLift™ XS | 18 mm | 16 mm (expands~20 mm) |
Paired Instrumentation
| 07-1000-010 | KeyLift™ XL Clamp — the dedicated insertion and in-situ distraction instrument for the XL platform. |
| 07-1000-110 | KeyLift™ XS Clamp — the dedicated insertion and in-situ distraction instrument for the XS platform. |
Materials and Construction
| Implant materials | Titanium alloy per ASTM F136 and stainless steel per ASTM F138 and A564 |
| Instrument materials | Stainless steel |
| Assembly | Both the KeyLift™ implant and KeyLift™ Clamp are provided pre-assembled |
| Sterility — implants | Single use only — implants in caddy are provided clean and non-sterile, and must be sterilized prior to use |
| Sterility — instruments | Reusable — clean, decontaminate, and steam-sterilize per the IFU prior to each use |
| Steam sterilization parameters | Prevacuum cycle — 270°F (132°C), 4-minute exposure, 30-minute drying |
Regulatory
KeyLift™ XL and KeyLift™ XS are FDA-cleared under K232484 for use as a posterior non-pedicle supplemental fixation device at a single level in the non-cervical spine (T1–S1). Classification: Class II, 21 CFR 888.3050 (Spinal Interlaminal Fixation Orthosis), product code PEK. Primary predicate: K153302 (Paradigm Spine coflex-F). Secondary predicate: K130438 (X-spine Axle Interspinous Fusion System).