# K161842: Overwatch Spine System

- Pathway: 510(k) (Traditional)
- Applicant: Amendia, Inc.
- Decided: Oct 13, 2016 after 100 days
- Product code: NKB (Thoracolumbosacral Pedicle Screw System)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 15 generations back to K040583 (2004). 237 ancestors in all.
6 later devices descend from it; 1 cites it directly.
0 of 244 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151488: Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System, Orthofix, Inc. (2015) Summary page 4.
- K153589: CD HORIZON Spinal System, Medtronic Sofamor Danek USA, Inc. (2016) Summary page 4.
- K132925: Savannah-T, Reduction, Savannah-T, High-Top, Savannah-T, Monoaxial Mid-Top, Savannah-T, Low-Top, Savannah-Link, Amendia, Inc. (2014) Summary page 4.

## Most influential descendants
- K191576: Mercury® Spinal System, Overwatch® Spinal System (2019), 5 descendants of its own
- K222516: Mercury® II Spinal System (2022), 3 descendants of its own
- K243916: Primus Spinal Fixation System (2025), 2 descendants of its own
- K251154: RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation Instruments (2025), 1 descendant of its own
- K262193: RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor Sacroiliac Fixation System with NanoACTIV Surface Technology (2026), 0 descendants of its own

## Recalls of this device
- Nov 22, 2016 · Class II · Z-0883-2017: The rods are packaged in packages with unacceptable seals. In some cases, the integrity of the seal is compromised by channels or voids.

## Indications for use
The Overwatch Spine System is intended for non-cervical pedicle and non-pedical fixation (T1-S2/Ilium) in skeletally mature patients as an adjunct to fusion for the following instabilities/deformities in the thoracolumbar and sacral spine: a) degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies) b) spondylolisthesis, c) trauma (i.e., fracture or dislocation), d) spinal stenosis, e) deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), f) tumor, g) pseudoarthrosis, and h) failed previous fusion The Overwatch Spine System is intended for the following indications when used in a posterior percutaneous approach for non-cervical pedicle and non-pedical fixation: Degenerative disc disease; spondylolisthesis; trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e. scoliosis, kyphosis and/or lordosis); tumor; pseudoarthrosis; and/or failed previous fusion When used for posterior non-cervical pedicle screw fixation in pediatric patients the Overwatch Spine System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. These devices are to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

Source page: https://510kreport.com/device/K161842
Methodology: https://510kreport.com/methodology