# K231668: Spine CAMP™ (1.1)

- Pathway: 510(k) (Special)
- Applicant: Medical Metrics, Inc.
- Decided: Jul 7, 2023 after 30 days
- Product code: QIH (Automated Radiological Image Processing Software)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K022585 (2002). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K221632: Spine CAMP™, Medical Metrics, Inc. (2022) Summary page 4.

## Indications for use
Spine CAMP ™ is a fully-automated software that analyzes X-ray images of the spine to produce reports that contain static and/or motion metrics. Spine CAMP ™ can be used to obtain metrics from sagittal plane radiographs of the lumbar and/or cervical spine and it can be used to visualize intervertebral motion via an image registration method referred to as "stabilization." The radiographic metrics can be used to characterize and assess spinal health in accordance with established guidance. For example, common clinical uses include assessing spinal stability, alignment, degeneration, fusion, motion preservation, and implant performance. The metrics produced by Spine CAMP are intended to be used to support qualified and licensed professional healthcare practitioners in clinical decision making for skeletally mature patients of age 18 and above.

Source page: https://510kreport.com/device/K231668
Methodology: https://510kreport.com/methodology