# K001080: Spine System Evolution

- Pathway: 510(k) (Traditional)
- Applicant: Aesculap, Inc.
- Decided: Jun 29, 2000 after 86 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
Longest line of descent: 5 generations back to K901587 (1990). 33 ancestors in all.
62 later devices descend from it; 2 cite it directly.
0 of 96 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980484: Aesculap Spine System Evolution, Aesculap, Inc. (1998) Summary page 1.
- K982914: Aesculap Spine System Evolution: Additional Components, Aesculap, Inc. (1998) Summary page 1.
- K992738: Isobar Spinal System, Encore Orthopedics, Inc. (1999) Summary page 2.
- K990118: Isobar Spinal System, Scien'Tx USA, Inc. (1999) Summary page 2.
- K990721: Isolock Spinal System, Scien'Tx USA, Inc. (1999) Summary page 2.
- K984350: VSP System, Depuy Motech Acromed (1999) Summary page 2.
- K951846: Mirage Spinal System for Severe Spondylolisthesis, Alphatec Mfg., Inc. (1996) Summary page 2.
- K992792: Xia Spinal System C-C Adaptor, Howmedica Osteonics Corp. (1999) Summary page 2.
- K984251: Xia Spine System, Howmedica, Inc. (1999) Summary page 2.

## Most influential descendants
- K112551: S4 Spinal System (2011), 61 descendants of its own
- K123352: S4 Spinal System (2012), 51 descendants of its own
- K130291: S4 Spinal System (2013), 44 descendants of its own
- K182377: CarboClear® Pedicle Screw System (2018), 39 descendants of its own
- K190545: VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0 (2019), 29 descendants of its own

## Indications for use
Spine System Evolution is a pedicle screw system indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (1_3 to sacrum) with removal of the implants after the attainment of a solid fusion. In addition, Spine System Evolution is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). When used as a posterior, non-cervical, non-pedicle screw fixation system, Spine System Evolution is intended for hook fixation from T1 to the ilium / sacrum. The non-pedicle screw indications are degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by bistory and radiographic studies), spondylolisthesis, trauma (fracture or dislocation), spinal stenosis, deformities or curvatures (scoliosis, kyphosis and lordosis), tumor, pseudoarthrosis, and/or failed previous fusion.

Source page: https://510kreport.com/device/K001080
Methodology: https://510kreport.com/methodology