510(k) · Cleared
ClearedSpine System Evolution
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aesculap, Inc. · KWP Appliance, Fixation, Spinal Interlaminal
Cleared on Jun 29, 2000 as substantially equivalent to K980484 (Aesculap, Inc., 1998) and 8 other predicates after an 86-day review. Its family tree reaches back 5 generations to 1990. 62 later devices descend from it.
- Decided
- Jun 29, 2000
- Review
- 86 days
- Class
- Class II
- Product code
- KWP
- Recalls
- None
- Predicates
- 9
Its longest line of descent runs back 5 generations to K901587 (1990). 33 ancestors in all. 62 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK901587 TSRH Sacral L-ConnectorDanek Medical, Inc. · 1990
- 4 generations backK950099 Synergy (TM) TI Posterior Spinal SystemBuckman Co., Inc. · 1997
- 3 generations backK973836 Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the…Cross Medical Products, Inc. · 1998
- 2 generations backK980484 Aesculap Spine System EvolutionAesculap, Inc. · 1998
- 1 generation backK990118 Isobar Spinal SystemScien'Tx USA, Inc. · 1999
- This deviceK001080 Spine System EvolutionAesculap, Inc. · 2000
- Descendant · cites it directly · 61 of its ownK112551 S4 Spinal SystemAesculap Implant System, Inc. · 2011
- Descendant · cites it directly · 51 of its ownK123352 S4 Spinal SystemAesculap Implant Systems, Inc. · 2012
- Descendant · 2 generations on · 44 of its ownK130291 S4 Spinal SystemAesculap Implant System, Inc. · 2013
- Descendant · 3 generations on · 39 of its ownK182377 CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd. · 2018
- Descendant · 4 generations on · 29 of its ownK190545 VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG · 2019 · Recalled
Showing 5 of 62 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 62 · See all- K112551S4 Spinal SystemAesculap Implant System, Inc. · 2011 · cites it directly61descendants
- K123352S4 Spinal SystemAesculap Implant Systems, Inc. · 2012 · cites it directly51descendants
- K130291S4 Spinal SystemAesculap Implant System, Inc. · 2013 · 2 generations on44descendants
- K182377CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd. · 2018 · 3 generations on39descendants
- K190545VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG · 2019 · 4 generations on29descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K901587 | TSRH Sacral L-Connector | Danek Medical, Inc. | 1990 | — |
| −4 | K950099 | Synergy (TM) TI Posterior Spinal System | Buckman Co., Inc. | 1997 | — |
| −3 | K973836 | Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the Cross… | Cross Medical Products, Inc. | 1998 | — |
| −2 | K980484 | Aesculap Spine System Evolution | Aesculap, Inc. | 1998 | — |
| −1 | K990118 | Isobar Spinal System | Scien'Tx USA, Inc. | 1999 | — |
| 0 (this device) | K001080 | Spine System Evolution | Aesculap, Inc. | 2000 | — |
| +1 | K112551 | S4 Spinal System | Aesculap Implant System, Inc. | 2011 | — |
| +1 | K123352 | S4 Spinal System | Aesculap Implant Systems, Inc. | 2012 | — |
| +2 | K130291 | S4 Spinal System | Aesculap Implant System, Inc. | 2013 | — |
| +3 | K182377 | CarboClear® Pedicle Screw System | CarboFix Orthopedics, Ltd. | 2018 | — |
| +4 | K190545 | VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0 | Icotec AG | 2019 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1992 | 5 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 3 | 0 |
| 1996 | 4 | 0 |
| 1997 | 2 | 0 |
| 1998 | 4 | 0 |
| 1999 | 5 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 3 | 0 |
| 2017 | 6 | 0 |
| 2018 | 3 | 0 |
| 2019 | 4 | 0 |
| 2020 | 6 | 0 |
| 2021 | 3 | 0 |
| 2022 | 1 | 0 |
| 2023 | 8 | 0 |
| 2024 | 11 | 0 |
| 2025 | 6 | 0 |
| 2026 | 6 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KWP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (9)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K980484 | Aesculap Spine System EvolutionSummary page 1…arious hook styles and configurations. PURPOSE OF PREMARKET NOTIFICATION This submission seeks to expand the current product line for Aesculap’s Spine System Evolution (K980484, K982914) with new and modified components. There are no changes to the intended use, material composition or fundamental scient… | 1998 |
| * | K982914 | Aesculap Spine System Evolution: Additional ComponentsSummary page 1…ok styles and configurations. PURPOSE OF PREMARKET NOTIFICATION This submission seeks to expand the current product line for Aesculap’s Spine System Evolution (K980484, K982914) with new and modified components. There are no changes to the intended use, material composition or fundamental scientific tech… | 1998 |
| * | K992738 | Isobar Spinal SystemSummary page 2…s to those in Aesculap's current Spine System Evolution (K980484, K982914), as well as the following competitor spinal systems: " ISOBARO, ISOLOCKO Spinal System (K992738, K990118, K990721) " ISOLA / VSP System (K984350) " Mirage TM Spinal System (K951846) " Xia T11Spinal S… | 1999 |
| * | K990118 | Isobar Spinal SystemSummary page 2…e in Aesculap's current Spine System Evolution (K980484, K982914), as well as the following competitor spinal systems: " ISOBARO, ISOLOCKO Spinal System (K992738, K990118, K990721) " ISOLA / VSP System (K984350) " Mirage TM Spinal System (K951846) " Xia T11Spinal System (K9… | 1999 |
| * | K990721 | Isolock Spinal SystemSummary page 2…ulap's current Spine System Evolution (K980484, K982914), as well as the following competitor spinal systems: " ISOBARO, ISOLOCKO Spinal System (K992738, K990118, K990721) " ISOLA / VSP System (K984350) " Mirage TM Spinal System (K951846) " Xia T11Spinal System (K992792, K9… | 1999 |
| * | K984350 | VSP SystemSummary page 2…(K980484, K982914), as well as the following competitor spinal systems: " ISOBARO, ISOLOCKO Spinal System (K992738, K990118, K990721) " ISOLA / VSP System (K984350) " Mirage TM Spinal System (K951846) " Xia T11Spinal System (K992792, K984251)… | 1999 |
| * | K951846 | Mirage Spinal System for Severe SpondylolisthesisSummary page 2…ompetitor spinal systems: " ISOBARO, ISOLOCKO Spinal System (K992738, K990118, K990721) " ISOLA / VSP System (K984350) " Mirage TM Spinal System (K951846) " Xia T11Spinal System (K992792, K984251)… | 1996 |
| * | K992792 | Xia Spinal System C-C AdaptorSummary page 2…, ISOLOCKO Spinal System (K992738, K990118, K990721) " ISOLA / VSP System (K984350) " Mirage TM Spinal System (K951846) " Xia T11Spinal System (K992792, K984251) 005 DEPA… | 1999 |
| * | K984251 | Xia Spine SystemSummary page 2…O Spinal System (K992738, K990118, K990721) " ISOLA / VSP System (K984350) " Mirage TM Spinal System (K951846) " Xia T11Spinal System (K992792, K984251) 005 DEPARTMENTOFH… | 1999 |
What descends from it? (62)
See all 622 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 10 years and passes through 5 companies; a new generation was cleared every 1.1 years on median.
- None of the 33 ancestors has a recall.
- Of its descendants, K112551 (Aesculap Implant System, Inc., 2011) has gone furthest, with 61 descendants of its own.
- 1 other device also cites its predicate K980484.
How does its category compare?
All KWP devicesKWP Appliance, Fixation, Spinal Interlaminal: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KWP
9in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · KWP
113in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWP
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWP
494in 2025
MAUDE reports naming product code KWP, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 14 | 96 | 2 | 210 |
| 2008 | 13 | 50 | 1 | 594 |
| 2009 | 12 | 89 | 23 | 682 |
| 2010 | 14 | 186 | 2 | 474 |
| 2011 | 12 | 67 | 6 | 792 |
| 2012 | 18 | 112 | 1 | 918 |
| 2013 | 12 | 99 | 3 | 1,090 |
| 2014 | 13 | 138 | 0 | 1,022 |
| 2015 | 9 | 113 | 1 | 1,348 |
| 2016 | 0 | — | 3 | 1,379 |
| 2017 | 0 | — | 0 | 864 |
| 2018 | 0 | — | 1 | 657 |
| 2019 | 0 | — | 2 | 518 |
| 2020 | 0 | — | 0 | 796 |
| 2021 | 0 | — | 0 | 525 |
| 2022 | 0 | — | 2 | 335 |
| 2023 | 0 | — | 0 | 332 |
| 2024 | 0 | — | 0 | 436 |
| 2025 | 0 | — | 0 | 494 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (190 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K001080 · printed Nov 5, 2026
Cite this page
510(k) Report. “K001080: Spine System Evolution.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K001080
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026