# K253216: IntraOp Alignment System; CONTOUR3D Bending System

- Pathway: 510(k) (Traditional)
- Applicant: Alphatec Spine, Inc.
- Decided: Jun 25, 2026 after 269 days
- Product code: SIN (Automated Intraoperative Spinal Rod Bending System)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 32 generations back to K841189 (1984). 1,113 ancestors in all.
No later device cites it as a predicate yet.
2 of 1,114 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K240199: IntraOp Alignment System, Alphatec Spine, Inc. (2024) Summary page 6.
- K232275: Invictus® Spinal Fixation System, Alphatec Spine, Inc. (2023) Summary page 6.

## Indications for use
IntraOp Alignment System: The IntraOp Alignment System is intended for use in applications where a mobile C-arm fluoroscope is incorporated to aid in diagnosis and treatment during spinal surgery. The IntraOp Alignment System is also intended to assist healthcare professionals in viewing, storing, and measuring spinal alignment assessment images at various time points during surgery, as well as planning spinal surgical procedures, including a user-defined, patient-specific rod plan during surgery. The IntraOp Alignment System is intended for adults and pediatrics. CONTOUR3D Bending System: The CONTOUR3D Bending System is intended to intraoperatively bend compatible Alphatec spinal rods by generating and executing bending instructions in accordance with a user-defined rod plan and data imported from the IntraOp Alignment System.

Source page: https://510kreport.com/device/K253216
Methodology: https://510kreport.com/methodology