# K222107: Black Diamond™ POCT Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Osseus Fusion Systems
- Decided: Nov 3, 2022 after 108 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: 18 generations back to K853033 (1985). 282 ancestors in all.
No later device cites it as a predicate yet.
1 of 283 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172495: Reform® POCT System, Precision Spine, Inc. (2018) Summary page 4.
- K190071: Perla® Posterior Cervico-Thoracic Fixation System, Spineart (2019) Summary page 4.
- K171444: YUKON OCT Spinal System, K2m, Inc. (2017) Summary page 4.

## Indications for use
The Black Diamond™ POCT Spinal 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 cervical spine (Cl to C7) and the upper thoracic spine (Tl-T3); traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusion (e.g., pseudoarthrosis); tumors involving the cervical/thoracic 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 Black Diamond™ POCT Spinal System is also intended to restore the integrity of the spinal column even in the absences 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. To achieve additional levels of fixation, the Black Diamond™ POCT Spinal System may be connected to the Osseus Black Diamond™ Pedicle Screw System using transition rods or anatomically-bent rods.

Source page: https://510kreport.com/device/K222107
Methodology: https://510kreport.com/methodology