Lumbar Impaction Set
by T. Korossurgical Instruments Corp. 510(k)
Active
510(k) K875290
Overview
The Lumbar Impaction Set is a surgical instrument system designed for spinal procedures, specifically intended for impaction applications in lumbar spine surgery. It includes tools and components used to compress or stabilize vertebral structures, aiding in the alignment and fixation of the lumbar spine. The device falls under the orthopedic category and is classified under product code KWP, reflecting its specialized use in spinal orthopedic interventions.
This set is supplied as a reusable surgical instrument, intended for use in controlled sterile environments such as operating rooms. It is regulated under FDA 510(k) clearance (K875290) and was determined substantially equivalent to a predicate device through the Traditional review pathway. The device is not indicated for MRI use and must be handled, stored, and reprocessed according to standard surgical instrument protocols to maintain sterility and functionality. No additional regulatory approvals beyond the 510(k) clearance are referenced in the data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK875290 | Date4 Mar 1988 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- KWP
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3050
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Other devices from T. Korossurgical Instruments Corp.
Questions
What types of spinal procedures is the Lumbar Impaction Set specifically designed for, and how does it assist in surgery?
The Lumbar Impaction Set is designed specifically for lumbar spine surgery, where it aids in compressing or stabilizing vertebral structures. This helps achieve proper alignment and fixation of the lumbar spine during procedures, ensuring better postoperative stability and support.
Is the Lumbar Impaction Set intended for single-use or reusable applications, and what storage guidelines should be followed?
The Lumbar Impaction Set is supplied as a reusable surgical instrument, meaning it must be carefully reprocessed after each use following standard surgical instrument protocols. Proper handling, cleaning, sterilization, and storage in a controlled sterile environment are essential to maintain functionality and prevent contamination.
What regulatory pathway was used to clear the Lumbar Impaction Set, and how does this affect its use in clinical settings?
The Lumbar Impaction Set received FDA clearance through a 510(k) Traditional review pathway, determined to be substantially equivalent to a predicate device (K875290). This means it meets FDA standards for safety and effectiveness as established by prior orthopedic spinal instruments, allowing its use in clinical settings under standard surgical protocols.
Can the Lumbar Impaction Set be used in MRI environments, and if not, what alternatives should clinicians consider?
No, the Lumbar Impaction Set is not indicated for MRI use. Clinicians should avoid using it in MRI environments due to potential interference or safety risks. If MRI compatibility is required, alternative non-ferromagnetic spinal stabilization tools should be selected instead.
What key details should clinicians know about the manufacturer and contact information for the Lumbar Impaction Set?
The Lumbar Impaction Set is manufactured by T. Korossurgical Instruments Corp., headquartered at 610 Flinn Ave., Moorepark, CA 93021, USA. For inquiries, the contact person is Tibor Koros, ensuring clinicians can reach the manufacturer for technical support, reprocessing guidance, or additional product information.