# K033271: Dynalok Classic Spinal System

- Pathway: 510(k) (Special)
- Applicant: Medtronic Sofamor Danek
- Decided: Nov 6, 2003 after 27 days
- Product code: MNI (Orthosis, Spinal Pedicle Fixation)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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

## Indications for use
When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the DYNALOK CLASSIC™ Spinal 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 CLASSIC™ Spinal System is indicated for skeletally mature patients: (1) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-Sl) vertebral joint; (2) who are receiving hsions using autogenous bone graft only; (3) 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 fusion mass. When used as a posterior, non-cervical, non-pedicle screw fixation system, the DYNALOK CLASSIC™ Spinal 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 (Le., scoliosis, kyphosis, andor lordosis), (5) fracture, (6) pseudarthrosis, (7) tumor resection, andlor (8) failed previous fbsion. When used as an anterolateral thoracic/lumbar system, the DYNALOK CLASSIC™ Spinal 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) fiacture, (6) pseudarthrosis, (7) tumor resection, andor (8) failed previous fusion.

Source page: https://510kreport.com/device/K033271
Methodology: https://510kreport.com/methodology