# K980484: Aesculap Spine System Evolution

- Pathway: 510(k) (Traditional)
- Applicant: Aesculap, Inc.
- Decided: Oct 2, 1998 after 235 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
Longest line of descent: 3 generations back to K901587 (1990). 23 ancestors in all.
251 later devices descend from it; 2 cite it directly.
0 of 275 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962757: J.B.S. Spine System with Pedicle Screws - Additional Components - Screws, Linking Plates, Hooks and Rod Clamp, J.B.S., S.A. (1996) Summary page 2.
- K953599: Clamp Assembly, J.B.S., S.A. (1995) Summary page 2.
- K935113: J.B.S. Implantable Spinal Fixation Device, J.B.S., S.A. (1994) Summary page 2.
- K964159: CD Spinal System, Sofamor Danek USA,Inc. (1997) Summary page 2.
- K962708: Titanium CD Horizon Spinal System, Sofamor Danek USA,Inc. (1997) Summary page 2.
- K961633: CD Horizon Spinal System, Sofamor Danek USA,Inc. (1996) Summary page 2.
- K951846: Mirage Spinal System for Severe Spondylolisthesis, Alphatec Mfg., Inc. (1996) Summary page 2.
- K980447: Depuy Motech Moss Miami Spinal System, DePuy Orthopaedics, Inc. (1998). Cleared while this submission was under review Summary page 2.
- K955348: Titanium Moss Miami Spinal System, Depuy, Inc. (1996). Our OCR of the scanned summary read K935348, FDA’s number for Odyssey Clinical Audiometer (Qualitone). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Moss® Miami Titanium Spinal System”.
- K973836: Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the Cross Medical-Synergy Anterior Spinal System, Cross Medical Products, Inc. (1998). Cleared while this submission was under review Summary page 2.
- K950099: Synergy (TM) TI Posterior Spinal System, Buckman Co., Inc. (1997) Summary page 2.
- K940631: Cross Medical - Synergy (TM) Spine System, Cross Medical Products, Inc. (1995) Summary page 2.

## Most influential descendants
- K990118: Isobar Spinal System (1999), 250 descendants of its own
- K061162: Bar Pedicle Screw Spinal Fixation System, Model 2020 (2006), 131 descendants of its own
- K092624: Firebird Spinal Fixation System (2009), 130 descendants of its own
- K100044: Firebird Spinal Fixation System, Firebird Side-Loading Body (2010), 117 descendants of its own
- K122901: Firebird Spinal Fixation System, Phoenix Mis Spinal Fixation System (2012), 116 descendants of its own

## Indications for use
When used as a pedicle screw fixation system, Aesculap’s 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). It is also intended for the treatment of severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra in skelatally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine with removal of the implants after the attainment of a solid fusion. Levels of pedicle screw fixation for this indication are from L;-S;. When used as a non-pedicle screw system, Aesculap’s Spine System® Evolution 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 T1 through S1.

Source page: https://510kreport.com/device/K980484
Methodology: https://510kreport.com/methodology