# K212627: True Tulip, True M.I.S.

- Pathway: 510(k) (Special)
- Applicant: Innovative Surgical Designs, Inc.
- Decided: Feb 18, 2022 after 183 days
- Product code: NKB (Thoracolumbosacral Pedicle Screw System)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
True Tulip and True M.L.S. are intended for posterior, noncervical (T1-S1) pedicle fixation to provide immobilization and stabilization in skeletally mature patients as an adjunct to fusion for the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, scoliosis, kyphosis, lordosis, spinal tumor, pseudoarthrosis, and failed previous fusion. When used for posterior non-cervical pedicle screw fixation in pediatric patients, True Tulip and True M.L.S. are indicated as an adjunct to fusion in the treatment of progressive spinal deformities (i.e., scoliosis, kyphosis, or lordosis) including adolescent idiopathic scoliosis (ALS), neuromuscular scoliosis, and congenital scoliosis. Additionally, True Tulip and True M.L.S. are intended to treat pediatric patients diagnosed with spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. Pediatric pedicle screw fixation is limited to a posterior approach. True Tulip and True M.L.S. are intended to be used with autograft and/or allograft.

Source page: https://510kreport.com/device/K212627
Methodology: https://510kreport.com/methodology