510(k) · Cleared
ClearedModification to Vertebron PSS Pedicle Screw System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vertebron, Inc. · MNI Orthosis, Spinal Pedicle Fixation
Cleared on Jul 2, 2008 as substantially equivalent to K071376 (Vertebron, Inc., 2007) and 3 other predicates after a 26-day review. Its family tree reaches back 8 generations to 1995. 22 later devices descend from it.
- Decided
- Jul 2, 2008
- Review
- 26 days
- Class
- Class II
- Product code
- MNI
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 8 generations to K951116 (1995). 27 ancestors in all, the oldest K933881 (1994). 22 later devices descend from it, 2 citing it directly.
- Root · 8 generations backK951116 Acromed Pedicle ScrewAcromed Corp. · 1995
- 7 generations backK963639 Acromed Pedicle ScrewAcromed Corp. · 1996
- 6 generations backK982511 Depuy Motech Moss Miami Spinal SystemsDepuy, Inc. · 1998
- 5 generations backK030383 Modification to Moss Miami Spinal System Polyaxial ScrewsDepuyacromed · 2003
- 4 generations backK033352 Vertebron PSS Pedicle Screw SystemVertebron, Inc. · 2004
- 3 generations backK043152 Vertebron PSS Pedicle Screw SystemVertebron, Inc. · 2005
- 2 generations backK051716 Vertebron PSS Pedicle Screw SystemVertebron, Inc. · 2005
- 1 generation backK071376 Modification to Vertebron PSS Pedicle Screw SystemVertebron, Inc. · 2007
- This deviceK081597 Modification to Vertebron PSS Pedicle Screw SystemVertebron, Inc. · 2008
- Descendant · cites it directly · 14 of its ownK131810 Osseus Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLC · 2013
- Descendant · 2 generations on · 13 of its ownK192121 Black Diamond Pedicle Screw SystemOsseus Fusion Systems · 2019
- Descendant · 3 generations on · 12 of its ownK213935 PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems · 2022
- Descendant · cites it directly · 6 of its ownK132280 Altus Spine Pedicle Screw SystemAltus Partners · 2013
- Descendant · 4 generations on · 5 of its ownK231199 Solar Lumbar Interbody Fusion SystemDegen Medical · 2023
Showing 5 of 22 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 22 · See all- K131810Osseus Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLC · 2013 · cites it directly14descendants
- K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems · 2019 · 2 generations on13descendants
- K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems · 2022 · 3 generations on12descendants
- K132280Altus Spine Pedicle Screw SystemAltus Partners · 2013 · cites it directly6descendants
- K231199Solar Lumbar Interbody Fusion SystemDegen Medical · 2023 · 4 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K951116 | Acromed Pedicle Screw | Acromed Corp. | 1995 | — |
| −7 | K963639 | Acromed Pedicle Screw | Acromed Corp. | 1996 | — |
| −6 | K982511 | Depuy Motech Moss Miami Spinal Systems | Depuy, Inc. | 1998 | — |
| −5 | K030383 | Modification to Moss Miami Spinal System Polyaxial Screws | Depuyacromed | 2003 | — |
| −4 | K033352 | Vertebron PSS Pedicle Screw System | Vertebron, Inc. | 2004 | — |
| −3 | K043152 | Vertebron PSS Pedicle Screw System | Vertebron, Inc. | 2005 | — |
| −2 | K051716 | Vertebron PSS Pedicle Screw System | Vertebron, Inc. | 2005 | — |
| −1 | K071376 | Modification to Vertebron PSS Pedicle Screw System | Vertebron, Inc. | 2007 | — |
| 0 (this device) | K081597 | Modification to Vertebron PSS Pedicle Screw System | Vertebron, Inc. | 2008 | — |
| +1 | K131810 | Osseus Black Diamond Pedicle Screw System | Osseus Fusion Systems, LLC | 2013 | — |
| +2 | K192121 | Black Diamond Pedicle Screw System | Osseus Fusion Systems | 2019 | — |
| +3 | K213935 | PISCES-SA Standalone ALIF Interbody System | Osseus Fusion Systems | 2022 | — |
| +1 | K132280 | Altus Spine Pedicle Screw System | Altus Partners | 2013 | — |
| +4 | K231199 | Solar Lumbar Interbody Fusion System | Degen Medical | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 2 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 4 | 0 |
| 2025 | 7 | 0 |
| 2026 | 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? (4)
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 |
|---|---|---|---|
| * | K071376 | Modification to Vertebron PSS Pedicle Screw SystemSummary page 1…Pedicle Screw Spinal System PROPRIETARY NAME: VERTEBRON PSS Pedicle Screw System PREDICATE DEVICES: VERTEBRON PSS Pedicle Screw System (K071376, K051716, K043152 & K033352) DEVICE DESCRIPTION: The modified VERTEBRON PSS TM Pedicle Scre… | 2007 |
| * | K051716 | Vertebron PSS Pedicle Screw SystemSummary page 1…tem PROPRIETARY NAME: VERTEBRON PSS Pedicle Screw System PREDICATE DEVICES: VERTEBRON PSS Pedicle Screw System (K071376, K051716, K043152 & K033352) DEVICE DESCRIPTION: The modified VERTEBRON PSS TM Pedicle Screw System… | 2005 |
| * | K043152 | Vertebron PSS Pedicle Screw SystemSummary page 1…RIETARY NAME: VERTEBRON PSS Pedicle Screw System PREDICATE DEVICES: VERTEBRON PSS Pedicle Screw System (K071376, K051716, K043152 & K033352) DEVICE DESCRIPTION: The modified VERTEBRON PSS TM Pedicle Screw System is compri… | 2005 |
| * | K033352 | Vertebron PSS Pedicle Screw SystemSummary page 1…ME: VERTEBRON PSS Pedicle Screw System PREDICATE DEVICES: VERTEBRON PSS Pedicle Screw System (K071376, K051716, K043152 & K033352) DEVICE DESCRIPTION: The modified VERTEBRON PSS TM Pedicle Screw System is comprised of non… | 2004 |
What descends from it? (22)
See all 222 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 13 years and passes through 4 companies; a new generation was cleared every 1.3 years on median.
- 2 of the 27 ancestors have a recall of any class.
- Of its descendants, K131810 (Osseus Fusion Systems, LLC, 2013) has gone furthest, with 14 descendants of its own.
- 5 other devices also cite its predicate K071376.
How does its category compare?
All MNI devicesMNI Orthosis, Spinal Pedicle Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
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 VERTEBRON PSSTM Pedicle Screw System is intended for non-cervical, non-pedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in…
Read the full statement (117 words)
The VERTEBRON PSSTM Pedicle Screw System is intended for non-cervical, non-pedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients. The VERTEBRON PSSTM Pedicle Screw System is intended for non cervical pedicle fixation for the following indications: spondylolisthesis (Grade 3 and 4 at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment); trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081597 · printed Nov 4, 2026
Cite this page
510(k) Report. “K081597: Modification to Vertebron PSS Pedicle Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K081597
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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