# K142737: MAS PLIF Fixation system

- Pathway: 510(k) (Traditional)
- Applicant: Nu Vasive, Incorporated
- Decided: Dec 18, 2014 after 86 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
Longest line of descent: 14 generations back to K040583 (2004). 113 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 115 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132014: GSB Global Spinal Balance System, Nuvasive, Inc. (2013) Summary page 5.
- K090981: Modification to: Nuvasive Spherx System, Nuvasive, Inc. (2009) Summary page 5.
- K102514: Nuvasive Spherx II -Mas Deformity Spinal System, Nuvasive, Inc. (2010) Summary page 5.
- K121619: Nuvasive Polyaxial Spinal Screws, Nuvasive, Inc. (2012) Summary page 5.
- K133221: Arsenal Spinal Fixation System, Alphatec Spine, Inc. (2014) Summary page 5.

## Most influential descendants
- K172469: TiLock Modular Spinal System (2017), 0 descendants of its own

## Indications for use
When used as a pedicle screw fixation system, the NuVasive MAS PLIF Fixation System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the posterior thoracic, lumbar, and sacral spine: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) degenerative spondylolisthesis with objective evidence of neurologic impairment, (3) fracture, (4) dislocation, (5) scoliosis, (6) kyphosis, (7) spinal tumor, and/or (8) failed previous fusion (pseudoarthrosis). When used for posterior non-cervical screw fixation in pediatric patients, the NuVasive MAS PLIF Fixation System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. Additionally the NuVasive MAS PLIF Fixation System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis / spondylolysis, and fracture caused by tumor and/or trauma. Pediatric pedicle screw fixation is limited to a posterior approach and is intended to be used with autograft and/or allograft. The NuVasive MAS PLIF Fixation System is also indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebral joint in skeletally mature patients receiving fusion by autogenous bone graft, having the device fixed or attached to the lumbar and sacral spine (L3 to sacrum), with removal of the implants after attainment of a solid fusion. When used as an anterolateral non-pedicle screw system in the thoracic and lumbar spine, the NuVasive MAS PLIF Fixation System is also intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spinal stenosis, (3) spondylolisthesis, (4) spinal deformities, (5) fracture, (6) pseudoarthosis, (7) tumor resection, and/or (8) failed previous fusion.

Source page: https://510kreport.com/device/K142737
Methodology: https://510kreport.com/methodology