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, LLC · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Jun 2, 2020 as substantially equivalent to K181339 (Altus Partners, LLC, 2018) after a 113-day review. Its family tree reaches back 15 generations to 1985. 4 later devices descend from it.
- Decided
- Jun 2, 2020
- Review
- 113 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 15 generations to K853033 (1985). 109 ancestors in all, the oldest K841189 (1984). 4 later devices descend from it, 2 citing it directly.
- Root · 15 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 11 generations between
- 3 generations backK111571 Viper SystemsJohnson & Johnson · 2011
- 2 generations backK121728 Tiger Spine SystemCorelink, LLC · 2012
- 1 generation backK181339 Altus Spine Pedicle Screw SystemAltus Partners, LLC · 2018
- This deviceK200322 Altus Spine Pedicle Screw SystemAltus Partners, LLC · 2020
- Descendant · cites it directly · 3 of its ownK200922 Altus Spine HA Pedicle Screw SystemAltus Partners, LLC · 2021
- Descendant · cites it directly · 2 of its ownK211027 Altus Spine Pedicle Screw SystemAltus Partners, LLC · 2022
- Descendant · 2 generations on · 1 of its ownK230766 Altus Spine Monaco Pedicle Screw SystemAltus Spine · 2023
- Descendant · 3 generations on · 0 of its ownK243419 Altus Spine Navigation SystemAltus Partners, LLC · 2025
Show all 15 generations
- Root · 15 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 14 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
- 13 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
- 12 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
- 11 generations backK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
- 10 generations backK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
- 9 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
- 8 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
- 7 generations backK062174 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 6 generations backK063156 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 5 generations backK063741 Expedium Spine SystemDepuy Spine, Inc. · 2007
- 4 generations backK080313 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2008
- 3 generations backK111571 Viper SystemsJohnson & Johnson · 2011
- 2 generations backK121728 Tiger Spine SystemCorelink, LLC · 2012
- 1 generation backK181339 Altus Spine Pedicle Screw SystemAltus Partners, LLC · 2018
- This deviceK200322 Altus Spine Pedicle Screw SystemAltus Partners, LLC · 2020
Most influential descendants
Showing 4 of 4 · See all- K200922Altus Spine HA Pedicle Screw SystemAltus Partners, LLC · 2021 · cites it directly3descendants
- K211027Altus Spine Pedicle Screw SystemAltus Partners, LLC · 2022 · cites it directly2descendants
- K230766Altus Spine Monaco Pedicle Screw SystemAltus Spine · 2023 · 2 generations on1descendant
- 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 |
|---|---|---|---|---|---|
| −15 | K853033 | Hartshill Rect & Wires, Spinal Fixation System | A.W. Showell (Surgicraft), Ltd. | 1985 | — |
| −14 | K965221 | Ransford Cervical Fixation System | Surgicraft, Ltd. | 1997 | — |
| −13 | K982322 | Synthes Spine Occipital-Cervical Plate/Rod and Hook System | Synthes (Usa) | 1998 | — |
| −12 | K002733 | Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2000 | — |
| −11 | K013222 | Summit Occipito-Cervico- Thoracic (Oct) Spinal System | Depuyacromed | 2001 | — |
| −10 | K022190 | Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2002 | — |
| −9 | K030103 | Summit Oct Spinal System Minipolyaxial Screws | Depuyacromed | 2003 | — |
| −8 | K041203 | Summit Oct Spinal System | Depuy Spine, Inc. | 2004 | — |
| −7 | K062174 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| −6 | K063156 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| −5 | K063741 | Expedium Spine System | Depuy Spine, Inc. | 2007 | — |
| −4 | K080313 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2008 | — |
| −3 | K111571 | Viper Systems | Johnson & Johnson | 2011 | — |
| −2 | K121728 | Tiger Spine System | Corelink, LLC | 2012 | — |
| −1 | K181339 | Altus Spine Pedicle Screw System | Altus Partners, LLC | 2018 | — |
| 0 (this device) | K200322 | Altus Spine Pedicle Screw System | Altus Partners, LLC | 2020 | — |
| +1 | K200922 | Altus Spine HA Pedicle Screw System | Altus Partners, LLC | 2021 | — |
| +1 | K211027 | Altus Spine Pedicle Screw System | Altus Partners, LLC | 2022 | — |
| +2 | K230766 | Altus Spine Monaco Pedicle Screw System | Altus Spine | 2023 | — |
| +3 | K243419 | Altus Spine Navigation System | Altus Partners, LLC | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 5 | 0 |
| 1996 | 4 | 0 |
| 1997 | 2 | 0 |
| 1998 | 9 | 0 |
| 1999 | 8 | 0 |
| 2000 | 9 | 0 |
| 2001 | 10 | 0 |
| 2002 | 7 | 0 |
| 2003 | 7 | 0 |
| 2004 | 14 | 0 |
| 2005 | 9 | 0 |
| 2006 | 2 | 0 |
| 2007 | 3 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 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 NKB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new NKB device
- #1 K223494 CD Horizon Spinal Systemscore 40.4 · 30 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K181339 | Altus Spine Pedicle Screw SystemSummary page 4…IETARY NAME: Altus Spine Pedicle Screw System PREDICATE DEVICES: The Primary predicate device is: Monaco Pedicle Screw System (K181339) CLASSIFICATION NAME: 21 CFR §888.3070 Thoracolumbosacral Pedicle Screw System PRODUCT CODES:… | 2018 |
What descends from it? (4)
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 35 years and passes through 8 companies; a new generation was cleared every 1.3 years on median.
- 7 of the 109 ancestors have a recall of any class.
- Of its descendants, K200922 (Altus Partners, LLC, 2021) has gone furthest, with 3 descendants of its own.
- 3 other devices also cite its predicate K181339.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · NKB
24in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NKB
61in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NKB
1in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · NKB
1,171in 2025
MAUDE reports naming product code NKB, 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 | 38 | 87 | 4 | 34 |
| 2008 | 36 | 59 | 5 | 82 |
| 2009 | 44 | 71 | 33 | 171 |
| 2010 | 37 | 111 | 4 | 462 |
| 2011 | 48 | 84 | 3 | 577 |
| 2012 | 60 | 79 | 13 | 1,747 |
| 2013 | 35 | 73 | 0 | 1,962 |
| 2014 | 46 | 90 | 3 (1) | 1,671 |
| 2015 | 55 | 90 | 3 | 1,446 |
| 2016 | 50 | 84 | 1 | 1,585 |
| 2017 | 63 | 69 | 1 | 1,618 |
| 2018 | 56 | 61 | 3 | 1,684 |
| 2019 | 39 | 84 | 1 | 1,915 |
| 2020 | 48 | 68 | 1 | 2,076 |
| 2021 | 32 | 61 | 0 | 1,745 |
| 2022 | 34 | 88 | 5 | 1,339 |
| 2023 | 44 | 72 | 2 | 919 |
| 2024 | 39 | 57 | 3 | 1,614 |
| 2025 | 24 | 61 | 1 | 1,171 |
| 2026 | 30 | 91 | 3 | — |
What is it indicated for?
The Altus Spine Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine. The Altus Spine Pedicle Screw System is intended for noncervical pedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origins…
Read the full statement (157 words)
The Altus Spine Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine.
The Altus Spine Pedicle Screw System is intended for noncervical pedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origins 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 Altus Spine Pedicle Screw System may be used for noncervical pedicle fixation via in posterior percutaneous approach with MIS instrumentation for the indications listed above. When used as an anterolateral thoracic/lumbar system the Altus Spine Pedicle Screw System may also be used for the same indications listed above as an adjunct to fusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200322 · printed Nov 3, 2026
Cite this page
510(k) Report. “K200322: Altus Spine 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/K200322
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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