# K163096: GPC BRAND Posterior, Non cervical Pedicle Screw Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Gpc Medical Limited
- Decided: Mar 31, 2017 after 147 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: 7 generations back to K901587 (1990). 57 ancestors in all.
No later device cites it as a predicate yet.
0 of 58 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100685: Zodiac Polyaxial Spinal Fixation System, Alphatec Spine, Inc. (2010) Summary page 6.
- K042964: MX Monoaxial Pedicle Screw, Scient'X (2004) Summary page 6.

## Indications for use
The GPC BRAND Posterior, Non cervical Pedicle Screw Spinal System is intended for use in the noncervical spine. The GPC BRAND Posterior, Non cervical Pedicle Screw Spinal System is used as an adjunct to fusion, using autograft or allograft, in the treatment of the following instabilities and deformities in skeletally mature patients. 1. Degenerative Disc Disease (DDD, defined as back pain of discogenic origin with degeneration of disc confirmed by history & radiographic studies) 2. Spondylolisthesis 3. Trauma (Fracture or Dislocation) 4. Spinal Stenosis 5. Scoliosis, kyphosis and/or lordosis 6. Pseudoarthrosis 7. Failed Previous Fusion The system is indicated for use in adult patients only. All implants are for single use only.

Source page: https://510kreport.com/device/K163096
Methodology: https://510kreport.com/methodology