# K023415: Modification to Dynalok Classic Spinal System

- Pathway: 510(k) (Special)
- Applicant: Medtronic Sofamor Danek
- Decided: Dec 13, 2002 after 63 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.
3 later devices descend from it; 2 cite it directly.
0 of 4 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) DYNALOK CLASSIC Spinal System: named in the summary without a submission number

## Most influential descendants
- K142939: Revolution Spinal Fixation System (2015), 2 descendants of its own
- K160216: Revolution Spinal Fixation System (2016), 1 descendant of its own
- K163056: Revolution™ Spinal Fixation System (2017), 0 descendants of its own

## Indications for use
When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the DYNALOK CLASSICTMSpinal System is indicated for one or more of the following: (1) degenerative spondylolisthesis with objective evidence of neurologic impairment, (2) fracture, (3) dislocation, (4) scoliosis, (5) kyphosis, (6) spinal tumor, andor (7) failed previous fusion (pseudarthrosis). In addition, when used as a pedicle screw fixation system, the DYNALOK CLASSICTMSpinal System is indicated for skeletally mature patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral 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 (L3 and below); and (d) who are having the device removed after the development of a solid fision mass. When used as a posterior, non-cervical, non-pedicle screw fixation system, the DYNALOK CLASSICTMSpinal System is intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spinal stenosis, (3) spondylolisthesis, (4)spinal deformities (i.e., scoliosis, kyphosis, andor lordosis), (5) fracture, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion. When used as an anterolateral thoracic/lumbar system, the DYNALOK CLASSICTMSpinal System is intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spinal stenosis, (3) spondylolisthesis, (4)spinal deformities (i.e., scoliosis, kyphosis, andor lordosis), ( 5 ) fracture, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion.

Source page: https://510kreport.com/device/K023415
Methodology: https://510kreport.com/methodology