510(k) · Cleared
ClearedVertebron PSS Pedicle Screw System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vertebron, Inc. · MNH Orthosis, Spondylolisthesis Spinal Fixation
Cleared on Feb 1, 2005 as substantially equivalent to K033352 (Vertebron, Inc., 2004) and 1 other predicate after a 78-day review. Its family tree reaches back 5 generations to 1995. 61 later devices descend from it.
- Decided
- Feb 1, 2005
- Review
- 78 days
- Class
- Class II
- Product code
- MNH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K951116 (1995). 24 ancestors in all, the oldest K933881 (1994). 61 later devices descend from it, 7 citing it directly.
- Root · 5 generations backK951116 Acromed Pedicle ScrewAcromed Corp. · 1995
- 4 generations backK963639 Acromed Pedicle ScrewAcromed Corp. · 1996
- 3 generations backK982511 Depuy Motech Moss Miami Spinal SystemsDepuy, Inc. · 1998
- 2 generations backK030383 Modification to Moss Miami Spinal System Polyaxial ScrewsDepuyacromed · 2003
- 1 generation backK033352 Vertebron PSS Pedicle Screw SystemVertebron, Inc. · 2004
- This deviceK043152 Vertebron PSS Pedicle Screw SystemVertebron, Inc. · 2005
- Descendant · cites it directly · 56 of its ownK051716 Vertebron PSS Pedicle Screw SystemVertebron, Inc. · 2005
- Descendant · cites it directly · 49 of its ownK071376 Modification to Vertebron PSS Pedicle Screw SystemVertebron, Inc. · 2007
- Descendant · 2 generations on · 24 of its ownK073430 Valeo Pedicle Screw Spinal SystemAmedica Corp. · 2008
- Descendant · cites it directly · 22 of its ownK081597 Modification to Vertebron PSS Pedicle Screw SystemVertebron, Inc. · 2008
- Descendant · 3 generations on · 21 of its ownK080767 Conquest Spinal SystemLife Spine · 2008
Showing 5 of 61 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 61 · See all- K051716Vertebron PSS Pedicle Screw SystemVertebron, Inc. · 2005 · cites it directly56descendants
- K071376Modification to Vertebron PSS Pedicle Screw SystemVertebron, Inc. · 2007 · cites it directly49descendants
- K073430Valeo Pedicle Screw Spinal SystemAmedica Corp. · 2008 · 2 generations on24descendants
- K081597Modification to Vertebron PSS Pedicle Screw SystemVertebron, Inc. · 2008 · cites it directly22descendants
- K080767Conquest Spinal SystemLife Spine · 2008 · 3 generations on21descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K951116 | Acromed Pedicle Screw | Acromed Corp. | 1995 | — |
| −4 | K963639 | Acromed Pedicle Screw | Acromed Corp. | 1996 | — |
| −3 | K982511 | Depuy Motech Moss Miami Spinal Systems | Depuy, Inc. | 1998 | — |
| −2 | K030383 | Modification to Moss Miami Spinal System Polyaxial Screws | Depuyacromed | 2003 | — |
| −1 | K033352 | Vertebron PSS Pedicle Screw System | Vertebron, Inc. | 2004 | — |
| 0 (this device) | K043152 | Vertebron PSS Pedicle Screw System | Vertebron, Inc. | 2005 | — |
| +1 | K051716 | Vertebron PSS Pedicle Screw System | Vertebron, Inc. | 2005 | — |
| +1 | K071376 | Modification to Vertebron PSS Pedicle Screw System | Vertebron, Inc. | 2007 | — |
| +2 | K073430 | Valeo Pedicle Screw Spinal System | Amedica Corp. | 2008 | — |
| +1 | K081597 | Modification to Vertebron PSS Pedicle Screw System | Vertebron, Inc. | 2008 | — |
| +3 | K080767 | Conquest Spinal System | Life Spine | 2008 | — |
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 |
|---|---|---|
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 4 | 0 |
| 2009 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 4 | 0 |
| 2014 | 3 | 0 |
| 2015 | 4 | 0 |
| 2016 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 3 | 0 |
| 2020 | 5 | 0 |
| 2021 | 4 | 0 |
| 2022 | 6 | 0 |
| 2023 | 5 | 0 |
| 2024 | 5 | 0 |
| 2025 | 7 | 0 |
| 2026 | 3 | 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? (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 |
|---|---|---|---|
| * | K033352 | Vertebron PSS Pedicle Screw SystemSummary page 1…Pedicle Screw Spinal System PROPRIETARY NAME: VERTEBRON PSSTM Pedicle Screw System PREDICATE DEVICES: VERTEBRON PSSTM Pedicle Screw System - K033352 DEVICE DESCRIPTION: The VERTEBRON PSSTM Pedicle Screw System is comprised of non-sterile, sin… | 2004 |
| * | K024096 | Optima, Spinal SystemSummary page 2…to the VERTEBRON PSSTM Pedicle Screw System without cross connectors (K033352), and Optima Spinal Fixation System; U&I America (K024096), which have received market clearance by the FDA. DEPARTMENT OF HEALTH & HUMAN SERVICES… | 2003 |
What descends from it? (61)
See all 617 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K051716 | Vertebron PSS Pedicle Screw System | 2005 | 56 |
| K071376 | Modification to Vertebron PSS Pedicle Screw System | 2007 | 49 |
| K081597 | Modification to Vertebron PSS Pedicle Screw System | 2008 | 22 |
| K131810 | Osseus Black Diamond Pedicle Screw System | 2013 | 14 |
| K132280 | Altus Spine Pedicle Screw System | 2013 | 6 |
| K120353 | Synster Pedicle Screw System Synster Plus Pedicle Screw System | 2012 | 3 |
| K073531 | Accin Pedicle Screw System | 2008 | 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 10 years and passes through 4 companies; a new generation was cleared every 1.3 years on median.
- 2 of the 24 ancestors have a recall of any class.
- Of its descendants, K051716 (Vertebron, Inc., 2005) has gone furthest, with 56 descendants of its own.
- 8 other devices also cite its predicate K033352.
How does its category compare?
All MNH devicesMNH Orthosis, Spondylolisthesis Spinal Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 VERTEBRON PSSTM Pedicle Screw System is intended for noncervical, nonpedicle 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 noncervical, nonpedicle 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/K043152 · printed Nov 3, 2026
Cite this page
510(k) Report. “K043152: Vertebron PSS Pedicle Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K043152
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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