# K961572: Versalok Screw Assembly (Proposed Name)

- Pathway: 510(k) (Traditional)
- Applicant: Wrightmedicaltechnologyinc
- Decided: Sep 17, 1996 after 147 days
- Product code: MNH (Orthosis, Spondylolisthesis Spinal 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
Longest line of descent: 1 generation back to K950074 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K950074: Wright-Loc (TM) Spinal Fixation System, Wrightmedicaltechnologyinc (1995) Summary page 1.
- (no number) MOSS® Miami System: named in the summary without a submission number

## Indications for use
The VERSALOK™ Screw Assembly is supplied as an alternative component for use with the WRIGHTLOCK™ Posterior Spinal Fixation System to fix the spine for appropriate indications. Limited indications apply when used as a pedicle screw. A WRIGHTLOCK™ construct with screws attached to the pedicles of the lumbar and sacral spine (L3 to S1) and autogenous bone graft may be used for the treatment of severe spondylolisthesis (Grade 3 and Grade 4) at the fifth lumbar - first sacral (L5-S1) vertebral joint. The device is intended to be implanted using a posterior surgical approach and removed after development of a solid fusion mass. When not used as a pedicle screw fixation system, various combinations of the system are also indicated to provide temporary stability of the thoracic, thoracolumbar, or lumbar spine (T1 to S1) during bony fusion healing secondary to: (1) Unstable spinal fractures (such as fracture dislocations) or spinal tumors; (2) Degenerative disk diseases of the spine (defined as back pain of diskogenic origin with degeneration of the disk confirmed by radiographic studies); (3) Spinal curvatures (such as idiopathic scoliosis, neuromuscular scoliosis/kyphoscoliosis with associated paralysis or spasticity, and secondary to spinal fractures) which are: progressive, despite other forms of treatment; detrimental to cardiopulmonary function; interfering with spinal mechanics or causing severe back pain; or cosmetically unacceptable, progressive, and painful.

Source page: https://510kreport.com/device/K961572
Methodology: https://510kreport.com/methodology