# K112025: Sure Lok Mini Posterior Cervical/Upper Thoracic System

- Pathway: 510(k) (Traditional)
- Applicant: Spinal USA
- Decided: Sep 15, 2011 after 62 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). 36 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991089: Synthes Cervifix System, Synthes Spine (1999) Summary page 1.
- K052201: Solanas Posterior Stabilization System, Alphatec Spine, Inc. (2005) Summary page 1.
- K072729: Sierra, Seaspine, Inc. (2008) Summary page 1.

## Most influential descendants
- K150851: Sure Lok Mini Posterior Cervical/Upper Thoracic System (2015), 3 descendants of its own
- K162300: Reform® POCT System (2016), 2 descendants of its own
- 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
When intended to promote fusion of the cervical spine (C1-C7) in skeletally mature patients, the Sure Lok Mini Posterior Cervical/Upper Thoracic System is indicated for the following: -DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiologic studies) -Spondylolisthesis -Spinal Stenosis -Fracture/dislocation -Revision of previous cervical spine surgery -Tumors The use of polyaxial screws is limited to placement in the upper thoracic spine (T1-T3) for the purposes of anchoring the construct. Polyaxial screws are not intended to be placed in the cervical spine. The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical (C1-C7) spine.

Source page: https://510kreport.com/device/K112025
Methodology: https://510kreport.com/methodology