# K162300: Reform® POCT System

- Pathway: 510(k) (Traditional)
- Applicant: Precision Spine, Inc.
- Decided: Nov 22, 2016 after 98 days
- Product code: NKG (Posterior Cervical Screw System)
- Device class: 2
- Regulation: 21 CFR 888.3075
- 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 K853033 (1985). 55 ancestors in all.
2 later devices descend from it; 1 cites it directly.
1 of 58 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152338: VERTEX (r) Reconstruction System, Medtronic Sofamor Danek USA, Inc. (2015) Summary page 6.
- K150851: Sure Lok Mini Posterior Cervical/Upper Thoracic System, Precision Spine, Inc. (2015) Summary page 6.
- K050979: S4 Spinal System, Aesculap, Inc. (2005) Summary page 6.
- K083071: Vertex Reconstruction System, Medtronic Sofamor Danek (2008) Summary page 6.

## Most influential descendants
- K172495: Reform® POCT System (2018), 1 descendant of its own
- K222107: Black Diamond™ POCT Spinal System (2022), 0 descendants of its own

## Indications for use
The Precision Spine Reform® POCT System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine from T1-T3: traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudarthrosis); tumors involving the cervical spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The Precision Spine Reform® POCT System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

Source page: https://510kreport.com/device/K162300
Methodology: https://510kreport.com/methodology