Streamline MIS Spinal Fixation System
by Pioneer Surgical Technology Inc. 2 variants
510(k) K192396
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK192396 | Date26 Nov 2019 | StatusActive |
Recalls
No FDA recalls found in the data synced 8 Nov 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- NKB
- FDA applicant
- Pioneer Surgical Technology, Inc.
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3070
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Streamline MIS Spinal Fixation System is a minimally invasive spinal fixation device designed for posterior, noncervical pedicle fixation in the thoracolumbar spine (T1–S2). It employs cannulated pedicle screws, set screws, and rods to create a rigid construct via percutaneous or mini-open approaches, enabling precise stabilization for spinal deformities or instability.
This system is supplied as a modular set of implants and instruments, allowing customization for individual patient anatomy. It is intended for single-use and requires sterile handling; compatibility with MRI is not specified. The device holds an FDA 510(k) clearance under product code NKB, classified as a traditional submission in the orthopedic category. Storage and regulatory compliance follow standard medical device protocols as outlined by the FDA.
Other devices from Pioneer Surgical Technology Inc.
Questions
AI-generated answers, 19 Sep 2026
What spinal regions and conditions is the Streamline MIS Spinal Fixation System designed to address?
The Streamline MIS Spinal Fixation System is specifically designed for posterior, noncervical pedicle fixation in the thoracolumbar spine, covering vertebrae from T1 to S2. It is intended for spinal deformities or instability requiring stabilization via a minimally invasive approach, such as percutaneous or mini-open techniques.
Is the Streamline MIS Spinal Fixation System reusable or single-use, and how should it be handled?
The Streamline MIS Spinal Fixation System is intended for single-use only and requires sterile handling to ensure patient safety. Since it is not designed for reuse, any unused components must be discarded according to sterile medical device protocols.
What types of implants and instruments are included in the Streamline MIS Spinal Fixation System, and can they be customized?
The system is supplied as a modular set of cannulated pedicle screws, set screws, and rods, allowing clinicians to customize the construct based on individual patient anatomy. This modularity supports flexibility in surgical planning for thoracolumbar stabilization.
How should the Streamline MIS Spinal Fixation System be stored, and are there any special considerations?
Storage follows standard medical device protocols as outlined by the FDA. Since the system is single-use and sterile, it should be kept in a clean, dry environment protected from contamination until use. No specific storage temperature or conditions are mentioned beyond general regulatory compliance.
What regulatory pathway was followed for FDA clearance of the Streamline MIS Spinal Fixation System?
The Streamline MIS Spinal Fixation System received FDA clearance through a 510(k) submission, classified under product code NKB in the orthopedic category. The submission was reviewed by the Orthopedic (OR) Advisory Committee and determined to be substantially equivalent to a predicate device, with a traditional review pathway.