510(k) · Cleared
ClearedARTS2 Spinal Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Advanced Medical Technologies · MNH Orthosis, Spondylolisthesis Spinal Fixation
Cleared on Dec 28, 2011 as substantially equivalent to K033150 (Advanced Medical Technologies AG, 2004) and 2 other predicates after a 387-day review. Its family tree reaches back 7 generations to 1990.
- Decided
- Dec 28, 2011
- Review
- 387 days
- Class
- Class II
- Product code
- MNH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K901587 (1990). 32 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK901587 TSRH Sacral L-ConnectorDanek Medical, Inc. · 1990
- 6 generations backK950099 Synergy (TM) TI Posterior Spinal SystemBuckman Co., Inc. · 1997
- 5 generations backK973836 Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the…Cross Medical Products, Inc. · 1998
- 4 generations backK980484 Aesculap Spine System EvolutionAesculap, Inc. · 1998
- 3 generations backK990118 Isobar Spinal SystemScien'Tx USA, Inc. · 1999
- 2 generations backK013444 Isobar Spinal SystemScien'Tx USA, Inc. · 2001
- 1 generation backK033150 Art Posterior Spinal SystemAdvanced Medical Technologies AG · 2004
- This deviceK103573 ARTS2 Spinal Fixation SystemAdvanced Medical Technologies · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K901587 | TSRH Sacral L-Connector | Danek Medical, Inc. | 1990 | — |
| −6 | K950099 | Synergy (TM) TI Posterior Spinal System | Buckman Co., Inc. | 1997 | — |
| −5 | K973836 | Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the Cross… | Cross Medical Products, Inc. | 1998 | — |
| −4 | K980484 | Aesculap Spine System Evolution | Aesculap, Inc. | 1998 | — |
| −3 | K990118 | Isobar Spinal System | Scien'Tx USA, Inc. | 1999 | — |
| −2 | K013444 | Isobar Spinal System | Scien'Tx USA, Inc. | 2001 | — |
| −1 | K033150 | Art Posterior Spinal System | Advanced Medical Technologies AG | 2004 | — |
| 0 (this device) | K103573 | ARTS2 Spinal Fixation System | Advanced Medical Technologies | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1992 | 5 | 0 |
| 1993 | 2 | 0 |
| 1994 | 3 | 0 |
| 1995 | 3 | 0 |
| 1996 | 4 | 0 |
| 1997 | 3 | 0 |
| 1998 | 3 | 0 |
| 1999 | 1 | 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 MNH? 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? (3)
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 |
|---|---|---|---|
| * | K033150 | Art Posterior Spinal SystemSummary page 1…MINI Class 11 3. Predicate or legally marketed devices which are substantially equivalent: ART Posterior Spinal System - K033150 (AMT) ISOBAR - K990118/K013444 (Scient'x) 4. Description of the device: The ART2 Spinal Fixation System has been de… | 2004 |
| * | K990118 | Isobar Spinal SystemSummary page 1…Class 11 3. Predicate or legally marketed devices which are substantially equivalent: ART Posterior Spinal System - K033150 (AMT) ISOBAR - K990118/K013444 (Scient'x) 4. Description of the device: The ART2 Spinal Fixation System has been developed with the objective of… | 1999 |
| * | K013444 | Isobar Spinal SystemSummary page 1…Class 11 3. Predicate or legally marketed devices which are substantially equivalent: ART Posterior Spinal System - K033150 (AMT) ISOBAR - K990118/K013444 (Scient'x) 4. Description of the device: The ART2 Spinal Fixation System has been developed with the objective of providin… | 2001 |
What descends from it?
No later submission names this one as a predicate yet.
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 21 years and passes through 7 companies; a new generation was cleared every 2.3 years on median.
- None of the 32 ancestors has a recall.
How does its category compare?
All MNH devicesMNH Orthosis, Spondylolisthesis Spinal Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · MNH
8in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · MNH
93in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MNH
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MNH
89in 2025
MAUDE reports naming product code MNH, 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 | 5 | 123 | 0 | 18 |
| 2008 | 13 | 65 | 0 | 30 |
| 2009 | 13 | 151 | 7 | 45 |
| 2010 | 10 | 106 | 0 | 59 |
| 2011 | 17 | 171 | 0 | 107 |
| 2012 | 7 | 93 | 1 | 433 |
| 2013 | 10 | 124 | 1 | 464 |
| 2014 | 12 | 140 | 0 | 286 |
| 2015 | 10 | 99 | 0 | 152 |
| 2016 | 8 | 93 | 1 | 216 |
| 2017 | 0 | — | 0 | 174 |
| 2018 | 0 | — | 0 | 129 |
| 2019 | 0 | — | 0 | 403 |
| 2020 | 0 | — | 0 | 432 |
| 2021 | 0 | — | 0 | 531 |
| 2022 | 0 | — | 0 | 265 |
| 2023 | 0 | — | 0 | 121 |
| 2024 | 0 | — | 0 | 302 |
| 2025 | 0 | — | 0 | 89 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The ART2 Spinal Fixation System is a pedicle screw system 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…
Read the full statement (125 words)
The ART2 Spinal Fixation System is a pedicle screw system 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).
As a pedicle screw system ART2 Spinal Fixation System is indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the 15-Si vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine ([3 to. sacrum) with removal of the implants after the attainment of a solid fusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103573 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103573: ARTS2 Spinal Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103573
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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