510(k) · Cleared
ClearedArt Posterior Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Advanced Medical Technologies AG · MNI Orthosis, Spinal Pedicle Fixation
Cleared on Mar 1, 2004 as substantially equivalent to K990118 (Scien'Tx USA, Inc., 1999) and 1 other predicate after a 153-day review. Its family tree reaches back 6 generations to 1990. 1 later device descends from it.
- Decided
- Mar 1, 2004
- Review
- 153 days
- Class
- Class II
- Product code
- MNI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K901587 (1990). 31 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK901587 TSRH Sacral L-ConnectorDanek Medical, Inc. · 1990
- 5 generations backK950099 Synergy (TM) TI Posterior Spinal SystemBuckman Co., Inc. · 1997
- 4 generations backK973836 Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the…Cross Medical Products, Inc. · 1998
- 3 generations backK980484 Aesculap Spine System EvolutionAesculap, Inc. · 1998
- 2 generations backK990118 Isobar Spinal SystemScien'Tx USA, Inc. · 1999
- 1 generation backK013444 Isobar Spinal SystemScien'Tx USA, Inc. · 2001
- This deviceK033150 Art Posterior Spinal SystemAdvanced Medical Technologies AG · 2004
- Descendant · cites it directly · 0 of its ownK103573 ARTS2 Spinal Fixation SystemAdvanced Medical Technologies · 2011
Most influential descendants
Showing 1 of 1 · See all- K103573ARTS2 Spinal Fixation SystemAdvanced Medical Technologies · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K901587 | TSRH Sacral L-Connector | Danek Medical, Inc. | 1990 | — |
| −5 | K950099 | Synergy (TM) TI Posterior Spinal System | Buckman Co., Inc. | 1997 | — |
| −4 | K973836 | Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the Cross… | Cross Medical Products, Inc. | 1998 | — |
| −3 | K980484 | Aesculap Spine System Evolution | Aesculap, Inc. | 1998 | — |
| −2 | K990118 | Isobar Spinal System | Scien'Tx USA, Inc. | 1999 | — |
| −1 | K013444 | Isobar Spinal System | Scien'Tx USA, Inc. | 2001 | — |
| 0 (this device) | K033150 | Art Posterior Spinal System | Advanced Medical Technologies AG | 2004 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 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 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? (2)
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 |
|---|---|---|---|
| * | K990118 | Isobar Spinal SystemSummary page 1…tion orthosis 888.3050 Equivalent Device The ART Posterior Spinal System is similar in design, material and indications as the ISOBAR Pedicle Screw System (Scient'x, K9901 18 and K01 3444). Device Description Pedicle Screws, monoaxial and. polyaxial, are available in various lengths and diameters. Th… | 1999 |
| * | K013444 | Isobar Spinal SystemSummary page 1…888.3050 Equivalent Device The ART Posterior Spinal System is similar in design, material and indications as the ISOBAR Pedicle Screw System (Scient'x, K9901 18 and K01 3444). Device Description Pedicle Screws, monoaxial and. polyaxial, are available in various lengths and diameters. The Screw is co… | 2001 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K103573 | ARTS2 Spinal Fixation System | 2011 | 0 |
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 14 years and passes through 6 companies; a new generation was cleared every 2.3 years on median.
- None of the 31 ancestors has a recall.
- Of its descendants, K103573 (Advanced Medical Technologies, 2011) has gone furthest, with 0 descendants of its own.
- 13 other devices also cite its predicate K990118.
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?
The ART Posterior Spinal 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 (157 words)
The ART Posterior Spinal 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 ART Posterior Spinal System is 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 (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.
The hooks are intended for posterior, nonpedicle screw fixation of the noncervical spine; hook and sacral/iliac screw fixation to the noncervical spine; and hook and sacral screw fixation to the TI-SI spine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033150 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033150: Art Posterior Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033150
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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