# K172495: Reform® POCT System

- Pathway: 510(k) (Traditional)
- Applicant: Precision Spine, Inc.
- Decided: Apr 11, 2018 after 236 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: 15 generations back to K853033 (1985). 62 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 64 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162300: Reform® POCT System, Precision Spine, Inc. (2016) Summary page 6.
- K151755: OASYS (r) System, Stryker Corporation (2015) Summary page 6.
- K153631: Zimmer Virage OCT Spinal Fixation System, Zimmer Spine, Inc. (2016) Summary page 6.

## Most influential descendants
- 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/K172495
Methodology: https://510kreport.com/methodology