# K971457: Bryan Posterior Spinal Fixator (BPSF), Modified

- Pathway: 510(k) (Traditional)
- Applicant: Arcan Orthopaedic Corp.
- Decided: Jul 16, 1997 after 110 days
- Product code: KWP (Appliance, Fixation, Spinal Interlaminal)
- Device class: 2
- Regulation: 21 CFR 888.3050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Harrington rod: named in the summary without a submission number
- (no number) Harrington hook: named in the summary without a submission number
- (no number) Harrington sacral screw: named in the summary without a submission number
- (no number) Harrington lag screw inserted into the pedicle of L5: named in the summary without a submission number
- (no number) Dwyer anterior vertebral screw system: named in the summary without a submission number

## Most influential descendants
- K053070: Contour II Spinal System (2006), 0 descendants of its own

## Indications for use
When used as a hook, rod, and ileo-sacral screw fixation system (KWP) T1-S1, the indications for use are: - spondylolisthesis - fracture - spinal stenosis - deformities(scoliosis, kyphosis, lordosis) - pseudarthrosis - tumor - multi-operated back or revision of previous surgery The system is indicated for pedicle screw fixation (MINH) L3-S1, ilium as follows: When used as a pedicle screw fixation system the device system is intended for patients: (a) having severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine; and (d) who are having the device removed after the development of a solid fusion mass.

Source page: https://510kreport.com/device/K971457
Methodology: https://510kreport.com/methodology