# K140359: Maximis Spinal Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Valorem Surgical
- Decided: Jan 7, 2015 after 329 days
- Product code: MNH (Orthosis, Spondylolisthesis Spinal Fixation)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: 144 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K000319 (2000). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120538: Palls M Spinal System, Korea Bone Bank Co., Ltd. (2012) Summary page 5.

## Recalls of this device
- Jun 21, 2017 · Class II · Z-2879-2017: Devices are not consistent with Quality System Requirements.
- Jun 21, 2017 · Class II · Z-2875-2017: Devices are not consistent with Quality System Requirements.
- Jun 21, 2017 · Class II · Z-2936-2017: Devices are not consistent with Quality System Requirements.
- Jun 21, 2017 · Class II · Z-2978-2017: Devices are not consistent with Quality System Requirements.
- Jun 21, 2017 · Class II · Z-2998-2017: Devices are not consistent with Quality System Requirements.
- Jun 21, 2017 · Class II · Z-2926-2017: Devices are not consistent with Quality System Requirements.
- Jun 21, 2017 · Class II · Z-2944-2017: Devices are not consistent with Quality System Requirements.
- Jun 21, 2017 · Class II · Z-3016-2017: Devices are not consistent with Quality System Requirements.
- Jun 21, 2017 · Class II · Z-2973-2017: Devices are not consistent with Quality System Requirements.
- Jun 21, 2017 · Class II · Z-2933-2017: Devices are not consistent with Quality System Requirements.
- Jun 21, 2017 · Class II · Z-3002-2017: Devices are not consistent with Quality System Requirements.
- Jun 21, 2017 · Class II · Z-2951-2017: Devices are not consistent with Quality System Requirements.
- Jun 21, 2017 · Class II · Z-3006-2017: Devices are not consistent with Quality System Requirements.
- Jun 21, 2017 · Class II · Z-2918-2017: Devices are not consistent with Quality System Requirements.
- Jun 21, 2017 · Class II · Z-2891-2017: Devices are not consistent with Quality System Requirements.
- Jun 21, 2017 · Class II · Z-2939-2017: Devices are not consistent with Quality System Requirements.
- Jun 21, 2017 · Class II · Z-2979-2017: Devices are not consistent with Quality System Requirements.
- Jun 21, 2017 · Class II · Z-2925-2017: Devices are not consistent with Quality System Requirements.
- Jun 21, 2017 · Class II · Z-2894-2017: Devices are not consistent with Quality System Requirements.
- Jun 21, 2017 · Class II · Z-2982-2017: Devices are not consistent with Quality System Requirements.
- Jun 21, 2017 · Class II · Z-2952-2017: Devices are not consistent with Quality System Requirements.
- Jun 21, 2017 · Class II · Z-2930-2017: Devices are not consistent with Quality System Requirements.
- Jun 21, 2017 · Class II · Z-2915-2017: Devices are not consistent with Quality System Requirements.
- Jun 21, 2017 · Class II · Z-2886-2017: Devices are not consistent with Quality System Requirements.
- Jun 21, 2017 · Class II · Z-3005-2017: Devices are not consistent with Quality System Requirements.
- Jun 21, 2017 · Class II · Z-2941-2017: Devices are not consistent with Quality System Requirements.
- Jun 21, 2017 · Class II · Z-2956-2017: Devices are not consistent with Quality System Requirements.
- Jun 21, 2017 · Class II · Z-2962-2017: Devices are not consistent with Quality System Requirements.
- Jun 21, 2017 · Class II · Z-2999-2017: Devices are not consistent with Quality System Requirements.
- Jun 21, 2017 · Class II · Z-2901-2017: Devices are not consistent with Quality System Requirements.
- Jun 21, 2017 · Class II · Z-2893-2017: Devices are not consistent with Quality System Requirements.
- Jun 21, 2017 · Class II · Z-3014-2017: Devices are not consistent with Quality System Requirements.
- Jun 21, 2017 · Class II · Z-2917-2017: Devices are not consistent with Quality System Requirements.
- Jun 21, 2017 · Class II · Z-2977-2017: Devices are not consistent with Quality System Requirements.
- Jun 21, 2017 · Class II · Z-2885-2017: Devices are not consistent with Quality System Requirements.
- Jun 21, 2017 · Class II · Z-2994-2017: Devices are not consistent with Quality System Requirements.
- Jun 21, 2017 · Class II · Z-2935-2017: Devices are not consistent with Quality System Requirements.
- Jun 21, 2017 · Class II · Z-3015-2017: Devices are not consistent with Quality System Requirements.
- Jun 21, 2017 · Class II · Z-2928-2017: Devices are not consistent with Quality System Requirements.
- Jun 21, 2017 · Class II · Z-2959-2017: Devices are not consistent with Quality System Requirements.
- Jun 21, 2017 · Class II · Z-2971-2017: Devices are not consistent with Quality System Requirements.
- Jun 21, 2017 · Class II · Z-2989-2017: Devices are not consistent with Quality System Requirements.
- Jun 21, 2017 · Class II · Z-2889-2017: Devices are not consistent with Quality System Requirements.
- Jun 21, 2017 · Class II · Z-2987-2017: Devices are not consistent with Quality System Requirements.
- Jun 21, 2017 · Class II · Z-2995-2017: Devices are not consistent with Quality System Requirements.
- Jun 21, 2017 · Class II · Z-2927-2017: Devices are not consistent with Quality System Requirements.
- Jun 21, 2017 · Class II · Z-3008-2017: Devices are not consistent with Quality System Requirements.
- Jun 21, 2017 · Class II · Z-2934-2017: Devices are not consistent with Quality System Requirements.
- Jun 21, 2017 · Class II · Z-2880-2017: Devices are not consistent with Quality System Requirements.
- Jun 21, 2017 · Class II · Z-2984-2017: Devices are not consistent with Quality System Requirements.

## Indications for use
The Valorem Surgical MAXIMIS™ Pedicle Screw Fixation System is intended for posterior pedicle screw fixation of the non-cervical posterior spine in skeletally mature patients. It provides stabilization and immobilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: 1) trauma (i.e. fracture or dislocation), 2) curvatures (scoliosis, kyphosis, and/or lordosis) 3) spinal tumor, 4) failed previous fusion, 5) pseudoarthrosis, 6) spinal stenosis. It is not intended for pedicle screw fixation above T8. This device may be used with autograft of allograft.

Source page: https://510kreport.com/device/K140359
Methodology: https://510kreport.com/methodology