# K111183: Ascent Posterior Occipital Thoracic (Poct) System (Titanium & Cobalt Chrome Rods)

- Pathway: 510(k) (Special)
- Applicant: Orthofix, Inc.
- Decided: May 24, 2011 after 27 days
- Product code: KWP (Appliance, Fixation, Spinal Interlaminal)
- Device class: 2
- Regulation: 21 CFR 888.3050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K853033 (1985). 80 ancestors in all.
22 later devices descend from it; 3 cite it directly.
0 of 103 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030197: Blackstone Posterior Cervical System, Blackstone Medical, Inc. (2003) Summary page 1.
- K080394: Blackstone Ascent Posterior Occipital Cervico-Thoracic (Poct) System, Blackstone Medical, Inc. (2008) Summary page 1.
- K092624: Firebird Spinal Fixation System, Blackstone Medical, Inc. (2009) Summary page 1.

## Most influential descendants
- K170647: Connector System (2017), 18 descendants of its own
- K172194: Connector System (2017), 16 descendants of its own
- K183639: Mariner Outrigger Revision System (2019), 8 descendants of its own
- K193396: PERLA® TL posterior osteosynthesis system (2020), 7 descendants of its own
- K203222: PERLA TL Posterior Osteosynthesis System (2020), 4 descendants of its own

## Indications for use
When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (Occiput-T3), the Ascent POCT System is indicated for: a. degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies); b. spondylolisthesis; c. fracture/dislocation; d. spinal stenosis; e. atlanto-axial fracture with instability; f. occipito-cervical dislocation; g. tumors; h. revision of previous cervical spine surgery The occipital bone screws are limited to occipital fixation only. The use of the multi-axial screws is limited to placement in the upper thoracic spine (T1-T3) for the treatment of thoracic conditions only. They are not intended to be placed in the cervical spine. The lateral offset adapter is indicated for use in the upper thoracic spine (T1-T3). The hooks are intended to be placed from C1 to T3. The Songer Cable (titanium) System to be used with the Ascent Posterior Occipital Cervical Thoracic System allows for wire/cable attachment to the posterior cervical spine. The Ascent Posterior Occipital Cervical Thoracic System can also be linked to the Orthofix Spinal Fixation System using the Ascent Axial or Parallel Rod Connector.

Source page: https://510kreport.com/device/K111183
Methodology: https://510kreport.com/methodology