Interspinous Plate System
510(k) K142378
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK142378 | Date18 Dec 2014 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- PEK
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3050
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Interspinous Plate System is a posterior, non-pedicle supplemental fixation device designed for spinal stabilization. It is intended for single-level fixation and attachment to spinous processes in the non-cervical spine (T1–S1) of skeletally mature patients, providing mechanical support to the vertebral column without pedicle engagement.
This device is supplied as a reusable surgical implant and is classified as a Class II medical device under FDA regulations. It is intended for use in orthopedic procedures and has received FDA 510(k) clearance (K142378) as substantially equivalent to a predicate device. Multiple model references are associated with the system, ensuring compatibility with various spinal anatomies. Sterility and handling instructions are manufacturer-specific and must be followed per surgical protocol.
Other devices from Precision Spine, Inc.
Questions
AI-generated answers, 19 Sep 2026
What is the primary purpose of the Interspinous Plate System and where is it used in the spine?
The Interspinous Plate System is designed for posterior spinal stabilization by providing mechanical support to the vertebral column without engaging the pedicles. It is intended for single-level fixation and attachment to spinous processes in the non-cervical spine, specifically from the thoracic (T1) to the sacral (S1) regions of skeletally mature patients.
Is the Interspinous Plate System intended for single-use or can it be reused in multiple procedures?
The Interspinous Plate System is explicitly described as a reusable surgical implant. However, sterility and handling instructions must be followed strictly per the manufacturer’s surgical protocol to ensure safe reuse.
How many different model references are available for the Interspinous Plate System, and why does this matter?
The system includes multiple model references (listed under FDA registration numbers), ensuring compatibility with various spinal anatomies. This variety allows surgeons to select the appropriate size and design for different patient anatomies, improving fit and stability during procedures.
What regulatory pathway was followed for FDA clearance of the Interspinous Plate System, and what does this mean for its use?
The device received FDA 510(k) clearance (K142378) under the Traditional 510(k) Review pathway, with a decision of Substantially Equivalent (SESE) to a predicate device. This means it was determined to have the same intended use and technological characteristics as an existing approved device, confirming its safety and effectiveness for spinal stabilization in the specified non-cervical regions.
Where can I find detailed sterility and handling instructions for the Interspinous Plate System?
Sterility and handling instructions for the Interspinous Plate System are manufacturer-specific and must be followed per Precision Spine, Inc.’s surgical protocol. These guidelines ensure proper preparation, sterilization, and reuse procedures to maintain device integrity and patient safety.