# K242827: A8 INTEGR8™ Porous Pedicle Screws

- Pathway: 510(k) (Traditional)
- Applicant: Allumin8, Inc.
- Decided: Oct 20, 2025 after 397 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: 20 generations back to K040583 (2004). 535 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 537 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200303: Reform Pedicle Screw System, Precision Spine (2020) Summary page 6.
- K202498: 4CIS SARA Spine System, 4CIS VERTU Spine System, Solco Biomedical Company India Private Limited (2021) Summary page 6.
- K190360: LineSider™ Spinal System, Integrity Implants, Inc. (2019) Summary page 6.

## Most influential descendants
- K262067: iFuse Granite Onyx™ Implant System (2026), 0 descendants of its own

## Indications for use
ALLUMIN8® A8 INTEGR8™ porous pedicle screws are intended to immobilize and stabilize spinal segments in skeletally mature patients as an adjunct to fusion as a pedicle screw fixation system to treat the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: 1. Degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies); 2. Spondylolisthesis; 3. Trauma (i.e., fracture or dislocation); 4. Spinal stenosis; 5. Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis); 6. Spinal Tumor; 7. Pseudoarthrosis; and 8. Failed previous fusion. When used for posterior, non-cervical, pedicle screw fixation in pediatric patients, the implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e. scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the ALLUMIN8® A8 INTEGR8™ porous pedicle screws are intended to treat pediatric patients diagnosed with spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudoarthrosis, and/or failed previous fusion. Pediatric pedicle screw fixation is limited to a posterior approach. ALLUMIN8® A8 INTEGR8™ Porous Pedicle Screws are intended to be used with autograft or allograft.

Source page: https://510kreport.com/device/K242827
Methodology: https://510kreport.com/methodology