# K980121: Aesculap Spine System Additional Components

- Pathway: 510(k) (Traditional)
- Applicant: Aesculap, Inc.
- Decided: Jun 10, 1998 after 147 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.
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 no predicate by number.

## Indications for use
When used as a non-pedicle screw fixation system, the Aesculap Spine System® is indicated for use in patients with degenerative disc disease (defined as back pain of discongenic origin with degeneration of the disc confirmed by history and radiographic studies), kyphosis, spondylolisthesis, neurological scoliosis, spine tumors and fractures. It is intended for posterior fixation from levels T, through S;. When used as a pedicle system, the Spine System® is intended only for patients (a) having severe spondylolisthesis (Grade 3 or 4 at the Ls-S4 vertebral joint; (b) who are receiving fusions using autologous bone graft only; (¢) who are having the device fixed or attached to the lumbar and sacral spine (note: levels of pedicle screw fixation for this indication are from L;-S;); and (d) who are having the device removed after the development of a solid fusion mass.

Source page: https://510kreport.com/device/K980121
Methodology: https://510kreport.com/methodology