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. · MNI Orthosis, Spinal Pedicle Fixation
Cleared on Feb 25, 2004 as substantially equivalent to K970635 (Smith & Nephew, Inc., Orthopaedic Div., 1997) and 2 other predicates after a 128-day review. Its family tree reaches back 4 generations to 1995. 62 later devices descend from it.
- Decided
- Feb 25, 2004
- Review
- 128 days
- Class
- Class II
- Product code
- MNI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K951116 (1995). 18 ancestors in all, the oldest K933881 (1994). 62 later devices descend from it, 9 citing it directly.
- Root · 4 generations backK951116 Acromed Pedicle ScrewAcromed Corp. · 1995
- 3 generations backK963639 Acromed Pedicle ScrewAcromed Corp. · 1996
- 2 generations backK982511 Depuy Motech Moss Miami Spinal SystemsDepuy, Inc. · 1998
- 1 generation backK030383 Modification to Moss Miami Spinal System Polyaxial ScrewsDepuyacromed · 2003
- This deviceK033352 Vertebron PSS Pedicle Screw SystemVertebron, Inc. · 2004
- Descendant · cites it directly · 61 of its ownK043152 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
Showing 5 of 62 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 62 · See all- K043152Vertebron PSS Pedicle Screw SystemVertebron, Inc. · 2005 · cites it directly61descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K951116 | Acromed Pedicle Screw | Acromed Corp. | 1995 | — |
| −3 | K963639 | Acromed Pedicle Screw | Acromed Corp. | 1996 | — |
| −2 | K982511 | Depuy Motech Moss Miami Spinal Systems | Depuy, Inc. | 1998 | — |
| −1 | K030383 | Modification to Moss Miami Spinal System Polyaxial Screws | Depuyacromed | 2003 | — |
| 0 (this device) | K033352 | Vertebron PSS Pedicle Screw System | Vertebron, Inc. | 2004 | — |
| +1 | 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 | — |
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 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 2 | 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 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? (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 |
|---|---|---|---|
| * | K970635 | Titanium Spinal Rod SystemSummary page 1…cle Screw Spinal System COMMON NAME Spinal Rod System PROPRIETARY NAME Vertebron PSST M Pedicle Screw System PREDICATE DEVICES U.S. Surgical/S.D.I. K970635 (et al) Depuy/Acromned K030383 (et al) Sofmnor/Danek K022778 (et al) DEVICE… | 1997 |
| * | K030383 | Modification to Moss Miami Spinal System Polyaxial ScrewsSummary page 1…Rod System PROPRIETARY NAME Vertebron PSST M Pedicle Screw System PREDICATE DEVICES U.S. Surgical/S.D.I. K970635 (et al) Depuy/Acromned K030383 (et al) Sofmnor/Danek K022778 (et al) DEVICE The device consists of a system of implantable… | 2003 |
| * | K022778 | Modification to TSRH Spinal SystemSummary page 1…Pedicle Screw System PREDICATE DEVICES U.S. Surgical/S.D.I. K970635 (et al) Depuy/Acromned K030383 (et al) Sofmnor/Danek K022778 (et al) DEVICE The device consists of a system of implantable rods, screws DESCRIPTION and hooks for the… | 2002 |
What descends from it? (62)
See all 629 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K043152 | Vertebron PSS Pedicle Screw System | 2005 | 61 |
| 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 |
| K151648 | Altus Spine Pedicle Screw System, Altus Spine MIS Pedicle Screw System, Valencia Pedicle… | 2015 | 5 |
| K211027 | Altus Spine Pedicle Screw System | 2022 | 2 |
| 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 9 years and passes through 4 companies; a new generation was cleared every 1.8 years on median.
- None of the 18 ancestors has a recall.
- Of its descendants, K043152 (Vertebron, Inc., 2005) has gone furthest, with 61 descendants of its own.
- 5 other devices also cite its predicate K970635.
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 VertebronPSSPedicleScrewSystem is intended for 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., scoltosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature…
Read the full statement (98 words)
The VertebronPSSPedicleScrewSystem is intended for 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., scoltosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients. The Vertebron PSS Pedicle Screw System is intended for non cervical pedicle fixation for the following indications: spondylolisthesis; trauma (i.e., fracture or dislocazion); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally maLure patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033352 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033352: Vertebron PSS Pedicle Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033352
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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