# K133214: Blackbird Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Choicespine, LP
- Decided: Mar 7, 2014 after 140 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: 9 generations back to K853033 (1985). 23 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050979: S4 Spinal System, Aesculap, Inc. (2005) Summary page 2.
- K070638: Theken Atoll Cervico-Thoracic System, Theken Spine, LLC (2007) Summary page 2.
- K052201: Solanas Posterior Stabilization System, Alphatec Spine, Inc. (2005) Summary page 2.
- K071380: Modification to Solanas Posterior Stabilization System, Alphatec Spine, Inc. (2007) Summary page 2.

## Most influential descendants
- K203561: ChoiceSpine Navigation System (2021), 1 descendant of its own
- K220024: ChoiceSpine Navigation System (2022), 0 descendants of its own
- K220025: ARx® Spinal System (2022), 0 descendants of its own

## Indications for use
The BLACKBIRD h Spinal System is Intended to be used In skeletally mature patents as an adjunct to fusion for stabilization of the cervical spine & thoracic spine (C1-T3) for the following conditions: * degenerative disc disease (ODD; defined as neck pain of discogenic origin with degeneration of the disk as confirmed by history & radiographic studies) * spondylolistiiesls " trauma " fracture / dislocation * spinal stenosis * atianto/axial fracture with instability * tumor * revision of previous cervical spine surgery The use of polyaxial screws Is limited to placement Inthe thoracic spine (TI-Tl) "for anchoring the construct only" and Is not Intended to be placed Inthe cervical spine. The use of the rods and hook components are Intended for use In(Cl -T). This system can be linked to a 06.0mmn rod system such as the Choice Spine Starfirem Pedicle Screw System.

Source page: https://510kreport.com/device/K133214
Methodology: https://510kreport.com/methodology