# K161267: Response BandLoc Spinal Fixation

- Pathway: 510(k) (Traditional)
- Applicant: OrthoPediatrics Corp.
- Decided: Aug 11, 2016 after 98 days
- Product code: OWI (Bone Fixation Cerclage, Sublaminar)
- Device class: 2
- Regulation: 21 CFR 888.3010
- 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: 6 generations back to K925812 (1993). 26 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110348: Universal Clamp Spinal Fixation System, Zimmer Spine (2011) Summary page 4.
- K060009: Abbott Spine Universal Clamp System, Abbott Spine, Inc. (2006) Summary page 4.

## Most influential descendants
- K200097: Response BandLoc Spinal Fixation (2020), 0 descendants of its own

## Recalls of this device
- Apr 24, 2017 · Class II · Z-2321-2017: Over-tensioning of the band resulting in damage to the band causing it to rupture

## Indications for use
The RESPONSE BandLoc Spinal Fixation is a temporary implant for use in orthopedic surgery. The system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures. The indications for use include the following applications: Spinal trauma surgery, used in sublaminar or facet wiring techniques; Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic and neuromuscular scoliosis in patients 8 years of age and older, adult scoliosis, kyphosis, and spondylolisthesis; Spinal degenerative surgery, as an adjunct to spinal fusions. The RESPONSE BandLoc Spinal Fixation may also be used in conjunction with other medical implants made of titanium alloy or CoCr alloy whenever "wiring" may help secure the attachment of other implants.

Source page: https://510kreport.com/device/K161267
Methodology: https://510kreport.com/methodology