510(k) · Cleared
ClearedAesculap Spine System Evolution
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aesculap, Inc. · MNI Orthosis, Spinal Pedicle Fixation
Cleared on Oct 2, 1998 as substantially equivalent to K962757 (J.B.S., S.A., 1996) and 11 other predicates after a 235-day review. Its family tree reaches back 3 generations to 1990. 251 later devices descend from it.
- Decided
- Oct 2, 1998
- Review
- 235 days
- Class
- Class II
- Product code
- MNI
- Recalls
- None
- Predicates
- 12
Its longest line of descent runs back 3 generations to K901587 (1990). 23 ancestors in all. 251 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK901587 TSRH Sacral L-ConnectorDanek Medical, Inc. · 1990
- 2 generations backK950099 Synergy (TM) TI Posterior Spinal SystemBuckman Co., Inc. · 1997
- 1 generation backK973836 Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the…Cross Medical Products, Inc. · 1998
- This deviceK980484 Aesculap Spine System EvolutionAesculap, Inc. · 1998
- Descendant · cites it directly · 250 of its ownK990118 Isobar Spinal SystemScien'Tx USA, Inc. · 1999
- Descendant · 2 generations on · 131 of its ownK061162 Bar Pedicle Screw Spinal Fixation System, Model 2020Applied Spine Technologies, Inc. · 2006
- Descendant · 3 generations on · 130 of its ownK092624 Firebird Spinal Fixation SystemBlackstone Medical, Inc. · 2009 · Recalled
- Descendant · 4 generations on · 117 of its ownK100044 Firebird Spinal Fixation System, Firebird Side-Loading BodyBlackstone · 2010
- Descendant · 4 generations on · 116 of its ownK122901 Firebird Spinal Fixation System, Phoenix Mis Spinal Fixation SystemOrthofix · 2012
Showing 5 of 251 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 251 · See all- K990118Isobar Spinal SystemScien'Tx USA, Inc. · 1999 · cites it directly250descendants
- K061162Bar Pedicle Screw Spinal Fixation System, Model 2020Applied Spine Technologies, Inc. · 2006 · 2 generations on131descendants
- K092624Firebird Spinal Fixation SystemBlackstone Medical, Inc. · 2009 · 3 generations on130descendants
- K100044Firebird Spinal Fixation System, Firebird Side-Loading BodyBlackstone · 2010 · 4 generations on117descendants
- K122901Firebird Spinal Fixation System, Phoenix Mis Spinal Fixation SystemOrthofix · 2012 · 4 generations on116descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K901587 | TSRH Sacral L-Connector | Danek Medical, Inc. | 1990 | — |
| −2 | K950099 | Synergy (TM) TI Posterior Spinal System | Buckman Co., Inc. | 1997 | — |
| −1 | K973836 | Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the Cross… | Cross Medical Products, Inc. | 1998 | — |
| 0 (this device) | K980484 | Aesculap Spine System Evolution | Aesculap, Inc. | 1998 | — |
| +1 | K990118 | Isobar Spinal System | Scien'Tx USA, Inc. | 1999 | — |
| +2 | K061162 | Bar Pedicle Screw Spinal Fixation System, Model 2020 | Applied Spine Technologies, Inc. | 2006 | — |
| +3 | K092624 | Firebird Spinal Fixation System | Blackstone Medical, Inc. | 2009 | 1 |
| +4 | K100044 | Firebird Spinal Fixation System, Firebird Side-Loading Body | Blackstone | 2010 | — |
| +4 | K122901 | Firebird Spinal Fixation System, Phoenix Mis Spinal Fixation System | Orthofix | 2012 | — |
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 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 5 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 4 | 0 |
| 2012 | 7 | 0 |
| 2013 | 7 | 0 |
| 2014 | 6 | 0 |
| 2015 | 9 | 0 |
| 2016 | 14 | 0 |
| 2017 | 16 | 0 |
| 2018 | 13 | 0 |
| 2019 | 14 | 0 |
| 2020 | 18 | 0 |
| 2021 | 13 | 0 |
| 2022 | 17 | 0 |
| 2023 | 23 | 0 |
| 2024 | 27 | 0 |
| 2025 | 26 | 0 |
| 2026 | 18 | 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 MNI? 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? (12)
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 |
|---|---|---|---|
| * | K962757 | J.B.S. Spine System with Pedicle Screws - Additional Components - Screws, Linking…Summary page 2…substantially equivalent in design, material composition, function and intended use to currently marketed spinal implant systems, such as: o Spine System® by Aesculap (K962757, K953599, K935113) ¢ CD Horizon™ Spinal System by Sofamor Danek (K964159, K962708, K961633 e Mirage™ Spinal System , by Alphatec… | 1996 |
| * | K953599 | Clamp AssemblySummary page 2…ially equivalent in design, material composition, function and intended use to currently marketed spinal implant systems, such as: o Spine System® by Aesculap (K962757, K953599, K935113) ¢ CD Horizon™ Spinal System by Sofamor Danek (K964159, K962708, K961633 e Mirage™ Spinal System , by Alphatec (K951846)… | 1995 |
| * | K935113 | J.B.S. Implantable Spinal Fixation DeviceSummary page 2…ivalent in design, material composition, function and intended use to currently marketed spinal implant systems, such as: o Spine System® by Aesculap (K962757, K953599, K935113) ¢ CD Horizon™ Spinal System by Sofamor Danek (K964159, K962708, K961633 e Mirage™ Spinal System , by Alphatec (K951846) e Moss®… | 1994 |
| * | K964159 | CD Spinal SystemSummary page 2…ntended use to currently marketed spinal implant systems, such as: o Spine System® by Aesculap (K962757, K953599, K935113) ¢ CD Horizon™ Spinal System by Sofamor Danek (K964159, K962708, K961633 e Mirage™ Spinal System , by Alphatec (K951846) e Moss® Miami Titanium Spinal System by Depuy Motech ™(K980447,… | 1997 |
| * | K962708 | Titanium CD Horizon Spinal SystemSummary page 2…se to currently marketed spinal implant systems, such as: o Spine System® by Aesculap (K962757, K953599, K935113) ¢ CD Horizon™ Spinal System by Sofamor Danek (K964159, K962708, K961633 e Mirage™ Spinal System , by Alphatec (K951846) e Moss® Miami Titanium Spinal System by Depuy Motech ™(K980447, K9355348… | 1997 |
| * | K961633 | CD Horizon Spinal SystemSummary page 2…rently marketed spinal implant systems, such as: o Spine System® by Aesculap (K962757, K953599, K935113) ¢ CD Horizon™ Spinal System by Sofamor Danek (K964159, K962708, K961633 e Mirage™ Spinal System , by Alphatec (K951846) e Moss® Miami Titanium Spinal System by Depuy Motech ™(K980447, K9355348) e Syner… | 1996 |
| * | K951846 | Mirage Spinal System for Severe SpondylolisthesisSummary page 2…: o Spine System® by Aesculap (K962757, K953599, K935113) ¢ CD Horizon™ Spinal System by Sofamor Danek (K964159, K962708, K961633 e Mirage™ Spinal System , by Alphatec (K951846) e Moss® Miami Titanium Spinal System by Depuy Motech ™(K980447, K9355348) e Synergy™ Posterior Spinal System by Cross® Medical P… | 1996 |
| * | K980447 | Depuy Motech Moss Miami Spinal System Cleared while this submission was under review Summary page 2…Horizon™ Spinal System by Sofamor Danek (K964159, K962708, K961633 e Mirage™ Spinal System , by Alphatec (K951846) e Moss® Miami Titanium Spinal System by Depuy Motech ™(K980447, K9355348) e Synergy™ Posterior Spinal System by Cross® Medical Products, Inc. (K973836, K950099, K940631) - 0003 === Page 3 ==… | 1998 |
| * | K955348 | Titanium Moss Miami Spinal System 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”. | 1996 |
| * | K973836 | Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the Cross Medical-Synergy… Cleared while this submission was under review Summary page 2…em , by Alphatec (K951846) e Moss® Miami Titanium Spinal System by Depuy Motech ™(K980447, K9355348) e Synergy™ Posterior Spinal System by Cross® Medical Products, Inc. (K973836, K950099, K940631) - 0003 v N 2 & 5 < P z K ¢ N é DEPARTMENT OF HEALTH & HUMAN SERVICES Public Heaith Servi… | 1998 |
| * | K950099 | Synergy (TM) TI Posterior Spinal SystemSummary page 2…lphatec (K951846) e Moss® Miami Titanium Spinal System by Depuy Motech ™(K980447, K9355348) e Synergy™ Posterior Spinal System by Cross® Medical Products, Inc. (K973836, K950099, K940631) - 0003 v N 2 & 5 < P z K ¢ N é DEPARTMENT OF HEALTH & HUMAN SERVICES Public Heaith Service ""“‘V… | 1997 |
| * | K940631 | Cross Medical - Synergy (TM) Spine SystemSummary page 2…K951846) e Moss® Miami Titanium Spinal System by Depuy Motech ™(K980447, K9355348) e Synergy™ Posterior Spinal System by Cross® Medical Products, Inc. (K973836, K950099, K940631) - 0003 v N 2 & 5 < P z K ¢ N é DEPARTMENT OF HEALTH & HUMAN SERVICES Public Heaith Service ""“‘Vam .. . F… | 1995 |
What descends from it? (251)
See all 2512 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 8 years and passes through 4 companies; a new generation was cleared every 1.1 years on median.
- None of the 23 ancestors has a recall.
- Of its descendants, K990118 (Scien'Tx USA, Inc., 1999) has gone furthest, with 250 descendants of its own.
- 2 other devices also cite its predicate K962757.
How does its category compare?
All MNI devicesMNI Orthosis, Spinal Pedicle Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MNI
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · MNI
168in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MNI
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MNI
80in 2025
MAUDE reports naming product code MNI, 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 | 20 | 82 | 26 | 83 |
| 2008 | 23 | 64 | 8 | 108 |
| 2009 | 18 | 86 | 3 | 138 |
| 2010 | 16 | 74 | 1 | 126 |
| 2011 | 17 | 111 | 0 | 146 |
| 2012 | 19 | 75 | 1 | 200 |
| 2013 | 14 | 77 | 4 | 824 |
| 2014 | 6 | 104 | 0 | 301 |
| 2015 | 12 | 54 | 1 | 260 |
| 2016 | 7 | 168 | 0 | 117 |
| 2017 | 1 | — | 0 | 247 |
| 2018 | 0 | — | 1 | 134 |
| 2019 | 0 | — | 0 | 188 |
| 2020 | 0 | — | 0 | 115 |
| 2021 | 0 | — | 0 | 270 |
| 2022 | 0 | — | 0 | 214 |
| 2023 | 0 | — | 0 | 122 |
| 2024 | 0 | — | 0 | 114 |
| 2025 | 0 | — | 0 | 80 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (187 words)
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.
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/K980484 · printed Nov 6, 2026
Cite this page
510(k) Report. “K980484: Aesculap Spine System Evolution.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K980484
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026