Spinal Simplicity · Class II · Cleared Apr 16, 2026
| K-number | K253523 |
| Device name | Freedom DS Decompression System |
| Applicant | Spinal Simplicity |
| Product code | HRX |
| Device class | Class II |
| Decision date | Apr 16, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 888.1100 |
The Freedom DS™ Decompression System is a set of surgical instruments used to perform minimally invasive lumbar decompressive procedures in skeletally mature patients. It consists of an Access Instrument, Reamer, Bone Removal Instrument, and Tissue Removal Instrument, supplied sterile for single use, and is used to treat various lumbar spinal conditions by removing portions of bone and soft tissue through a posterior surgical approach.
The device has similar technological characteristics to the predicate (instruments for targeting, access, tissue cutting/removal, materials, surgical approach, and principles of operation). Minor differences include instrument-based depth control mechanisms, a cutting angle orientation control feature for ergonomic handling, a quick release locking mechanism in the working channel grip, and geometric differences in cutting instrument interfaces.
Not stated in this summary. The document references biocompatibility, sterility, stability/shelf life, mechanical performance testing, and cadaver validation reports, but does not cite specific ISO, IEC, or ASTM standards by number.
The Freedom DS Decompression System is substantially equivalent to the Vertos mild Device Kit (predicate K233800) because it has identical indications for use and similar technological characteristics with only minor design differences that do not raise new safety or effectiveness questions. Performance testing demonstrates the device performs substantially equivalent to the predicate.
View the full FDA submission: accessdata.fda.gov