# K990922: Osteonics Spinal System Versatile Cross Connector

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Osteonics Corp.
- Decided: Jun 2, 1999 after 75 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.
206 later devices descend from it; 1 cites it directly.
0 of 207 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) CD Horizon™ Low Profile Crosslink’ Multi-Span™ Plates, Sofamor Danek: named in the summary without a submission number
- (no number) Multi Axial Low Profile Crosslink. Multi-Span™ Plates, Sofamor Danek: named in the summary without a submission number

## Most influential descendants
- K013688: Modification to Xia Spinal System (2001), 205 descendants of its own
- K052181: Modification to Xia Spinal System (2005), 202 descendants of its own
- K070631: Device Modification to Radius Spinal System (2007), 201 descendants of its own
- K082608: Radius Spinal System, Vitallium Rod #486613601 (2008), 200 descendants of its own
- K091291: Xia 3 Spinal System, Uniplanner/Reduction Screws & Vitallium Rod (2009), 169 descendants of its own

## Indications for use
The subject components, Osteonics® Spinal System Versatile Cross Connector, are single-use devices which are sold non-sterile and are intended for use only with the other titanium alloy components of the commercially available Osteonics® Spinal System. The uses for the legally marketed Osteonics® Spinal System are as follows: As a posterior, non-pedicle screw system of the T4-S2 spine, the Osteonics® Spinal System is indicated for: Long and short curve scoliosis Vertebral fracture or dislocation Spondylolisthesis Degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). Previously failed fusion Spinal tumor Pedicular Use: When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the Osteonics Spinal System is indicated for one or more of the following;: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). In addition, the Osteonics Spinal system is indicated for pedicle screw fixation in skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint, having fusions with autogenous bone graft, having the device fixed or attached to the lumbar and sacral spine (with pedicle placement at L.3 and below)with removal of the implants after the development of a solid fusion mass.

Source page: https://510kreport.com/device/K990922
Methodology: https://510kreport.com/methodology