# K163011: PHA S1 Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Phamedica, Inc.
- Decided: Jun 29, 2017 after 244 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: 8 generations back to K950697 (1995). 27 ancestors in all.
No later device cites it as a predicate yet.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000236: Synergy VLS Cap Nut Models 2206, 6102, Interpore Cross Intl. (2000) Summary page 5.
- K111940: S 100 Pedicle Screw System, Renovis Surgical Technologies, LLC (2012) Summary page 5.

## Indications for use
Phamedica PHA S1 Spinal System is intended for posterior non-cervical pedicle fixation of Thoracic, Lumbar, Sacral/Iliac Spine in skeletally mature patients, as an adjunct to fusion using autogeneous bone graft or allograft for all of the following indications: • Degenerative Disc Disease (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 • Curvatures (i.e., scoliosis, kyphosis, and/or lordosis) • Tumor • Pseudoarthrosis • Failed previous fusion in skeletally mature patients.

Source page: https://510kreport.com/device/K163011
Methodology: https://510kreport.com/methodology