510(k) · Cleared
ClearedAltus Spine Pedicle Screw System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Altus Partners · MNI Orthosis, Spinal Pedicle Fixation
Cleared on Oct 31, 2013 as substantially equivalent to K033352 (Vertebron, Inc., 2004) and 4 other predicates after a 100-day review. Its family tree reaches back 9 generations to 1995. 6 later devices descend from it.
- Decided
- Oct 31, 2013
- Review
- 100 days
- Class
- Class II
- Product code
- MNI
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 9 generations to K951116 (1995). 28 ancestors in all, the oldest K933881 (1994). 6 later devices descend from it, 2 citing it directly.
- Root · 9 generations backK951116 Acromed Pedicle ScrewAcromed Corp. · 1995
- 5 generations between
- 3 generations backK051716 Vertebron PSS Pedicle Screw SystemVertebron, Inc. · 2005
- 2 generations backK071376 Modification to Vertebron PSS Pedicle Screw SystemVertebron, Inc. · 2007
- 1 generation backK081597 Modification to Vertebron PSS Pedicle Screw SystemVertebron, Inc. · 2008
- This deviceK132280 Altus Spine Pedicle Screw SystemAltus Partners · 2013
- Descendant · cites it directly · 5 of its ownK151648 Altus Spine Pedicle Screw System, Altus Spine MIS Pedicle Screw…Altus Partners, LLC · 2015
- Descendant · cites it directly · 1 of its ownK221332 OsteoCentric Spine MIS Pedicle Fastener SystemOsteoCentric Technologies · 2022
- Descendant · 2 generations on · 1 of its ownK181281 Altus Spine Pedicle Screw SystemAltus Partners, LLC · 2018
- Descendant · 2 generations on · 0 of its ownK250520 OsteoCentric Navigated Instruments SystemOsteocentric Technologies, Inc. · 2025
- Descendant · 3 generations on · 0 of its ownK243419 Altus Spine Navigation SystemAltus Partners, LLC · 2025
Show all 9 generations
- Root · 9 generations backK951116 Acromed Pedicle ScrewAcromed Corp. · 1995
- 8 generations backK963639 Acromed Pedicle ScrewAcromed Corp. · 1996
- 7 generations backK982511 Depuy Motech Moss Miami Spinal SystemsDepuy, Inc. · 1998
- 6 generations backK030383 Modification to Moss Miami Spinal System Polyaxial ScrewsDepuyacromed · 2003
- 5 generations backK033352 Vertebron PSS Pedicle Screw SystemVertebron, Inc. · 2004
- 4 generations backK043152 Vertebron PSS Pedicle Screw SystemVertebron, Inc. · 2005
- 3 generations backK051716 Vertebron PSS Pedicle Screw SystemVertebron, Inc. · 2005
- 2 generations backK071376 Modification to Vertebron PSS Pedicle Screw SystemVertebron, Inc. · 2007
- 1 generation backK081597 Modification to Vertebron PSS Pedicle Screw SystemVertebron, Inc. · 2008
- This deviceK132280 Altus Spine Pedicle Screw SystemAltus Partners · 2013
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K151648Altus Spine Pedicle Screw System, Altus Spine MIS Pedicle Screw System, Valencia Pedicle…Altus Partners, LLC · 2015 · cites it directly5descendants
- K221332OsteoCentric Spine MIS Pedicle Fastener SystemOsteoCentric Technologies · 2022 · cites it directly1descendant
- K181281Altus Spine Pedicle Screw SystemAltus Partners, LLC · 2018 · 2 generations on1descendant
- K250520OsteoCentric Navigated Instruments SystemOsteocentric Technologies, Inc. · 2025 · 2 generations on0descendants
- K243419Altus Spine Navigation SystemAltus Partners, LLC · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K951116 | Acromed Pedicle Screw | Acromed Corp. | 1995 | — |
| −8 | K963639 | Acromed Pedicle Screw | Acromed Corp. | 1996 | — |
| −7 | K982511 | Depuy Motech Moss Miami Spinal Systems | Depuy, Inc. | 1998 | — |
| −6 | K030383 | Modification to Moss Miami Spinal System Polyaxial Screws | Depuyacromed | 2003 | — |
| −5 | K033352 | Vertebron PSS Pedicle Screw System | Vertebron, Inc. | 2004 | — |
| −4 | K043152 | Vertebron PSS Pedicle Screw System | Vertebron, Inc. | 2005 | — |
| −3 | K051716 | Vertebron PSS Pedicle Screw System | Vertebron, Inc. | 2005 | — |
| −2 | K071376 | Modification to Vertebron PSS Pedicle Screw System | Vertebron, Inc. | 2007 | — |
| −1 | K081597 | Modification to Vertebron PSS Pedicle Screw System | Vertebron, Inc. | 2008 | — |
| 0 (this device) | K132280 | Altus Spine Pedicle Screw System | Altus Partners | 2013 | — |
| +1 | K151648 | Altus Spine Pedicle Screw System, Altus Spine MIS Pedicle Screw System… | Altus Partners, LLC | 2015 | — |
| +1 | K221332 | OsteoCentric Spine MIS Pedicle Fastener System | OsteoCentric Technologies | 2022 | — |
| +2 | K181281 | Altus Spine Pedicle Screw System | Altus Partners, LLC | 2018 | — |
| +2 | K250520 | OsteoCentric Navigated Instruments System | Osteocentric Technologies, Inc. | 2025 | — |
| +3 | K243419 | Altus Spine Navigation System | Altus Partners, LLC | 2025 | — |
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 |
|---|---|---|
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2025 | 2 | 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? (5)
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…edicle Screw Spinal System PROPRIETARY NAME: Altus Spine Pedicle Screw System PREDICATE DEVICES: Vertebron PS5 Pedicle Screw System (K(033352, K(043152, K(051716, K(071376, & K(081597) CLASSIFICATION NAME: 21 CFR §888.30… | 2004 |
| * | K043152 | Vertebron PSS Pedicle Screw SystemSummary page 1…ew Spinal System PROPRIETARY NAME: Altus Spine Pedicle Screw System PREDICATE DEVICES: Vertebron PS5 Pedicle Screw System (K(033352, K(043152, K(051716, K(071376, & K(081597) CLASSIFICATION NAME: 21 CFR §888.3050 Spinal… | 2005 |
| * | K051716 | Vertebron PSS Pedicle Screw SystemSummary page 1…System PROPRIETARY NAME: Altus Spine Pedicle Screw System PREDICATE DEVICES: Vertebron PS5 Pedicle Screw System (K(033352, K(043152, K(051716, K(071376, & K(081597) CLASSIFICATION NAME: 21 CFR §888.3050 Spinal Interlamin… | 2005 |
| * | K071376 | Modification to Vertebron PSS Pedicle Screw SystemSummary page 1…us Spine Pedicle Screw System PREDICATE DEVICES: Vertebron PS5 Pedicle Screw System (K(033352, K(043152, K(051716, K(071376, & K(081597) CLASSIFICATION NAME: 21 CFR §888.3050 Spinal Interlaminal Fixation Orthosis… | 2007 |
| * | K081597 | Modification to Vertebron PSS Pedicle Screw SystemSummary page 1…icle Screw System PREDICATE DEVICES: Vertebron PS5 Pedicle Screw System (K(033352, K(043152, K(051716, K(071376, & K(081597) CLASSIFICATION NAME: 21 CFR §888.3050 Spinal Interlaminal Fixation Orthosis 2… | 2008 |
What descends from it? (6)
2 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 18 years and passes through 5 companies; a new generation was cleared every 1.3 years on median.
- 2 of the 28 ancestors have a recall of any class.
- Of its descendants, K151648 (Altus Partners, LLC, 2015) has gone furthest, with 5 descendants of its own.
- 8 other devices also cite its predicate K033352.
How does its category compare?
All MNI devicesMNI Orthosis, Spinal Pedicle Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 Altus Spine Pedlicle Screw System is a noncervical spinal fixation device intended to provide stabilization of the spinal segments. It is indicated for pedlicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (15-Si) vertebral joint in skeletally mature patients receiving fusion by autogenous bone graft only having implants attached to the lumbar and sacral spine (L3 to sacrum) with…
Read the full statement (212 words)
The Altus Spine Pedlicle Screw System is a noncervical spinal fixation device intended to provide stabilization of the spinal segments. It is indicated for pedlicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (15-Si) vertebral joint in skeletally mature patients receiving fusion by autogenous bone graft only having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.
In addition, the Altus Spine Pedlicle Screw System may be used 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:
1. Degenerative Spondylolisthesis with objective evidence of neurologic impairment;
2. Fracture;
3. Dislocation;
4. Scoliosis;
5. Kyphosis;
6. Spinal Tumor;
7. Failed previous fusion (pseudoarthrosis).
When used as a non-posterior, non-pedicle anterolateral fixation system the specific indications are:
1. Degenerative disc disease as defined by chronic back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies;
2. Spondylolisthesis;
3. Fracture;
4. Dislocation;
S. Scoliosis;
6. Kyphosis;
7. Lordlosis;
8. Spinal stenosis;
9. Spinal tumor;
10. Failed previous fusion (pseudoarthrosis)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132280 · printed Nov 4, 2026
Cite this page
510(k) Report. “K132280: Altus Spine 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/K132280
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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