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 Sep 16, 2022 as substantially equivalent to K200922 (Altus Partners, LLC, 2021) and 5 other predicates after a 528-day review. Its family tree reaches back 19 generations to 1985. 1 of the 230 devices in its family, counting itself, has a Class I recall. 2 later devices descend from it.
- Decided
- Sep 16, 2022
- Review
- 528 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 19 generations to K853033 (1985). 227 ancestors in all, the oldest K781443 (1978). 2 later devices descend from it, 1 citing it directly. 1 of the 230 devices in this family, counting this one, has a Class I recall.
- Root · 19 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 15 generations between
- 3 generations backK180210 CREO® Stabilization SystemGlobus Medical, Inc. · 2018
- 2 generations backK182478 Whistler Modular Pedicle Screw SystemEvolution Spine, LLC · 2019
- 1 generation backK200922 Altus Spine HA Pedicle Screw SystemAltus Partners, LLC · 2021
- This deviceK211027 Altus Spine Pedicle Screw SystemAltus Partners, LLC · 2022
- Descendant · cites it directly · 1 of its ownK230766 Altus Spine Monaco Pedicle Screw SystemAltus Spine · 2023
- Descendant · 2 generations on · 0 of its ownK243419 Altus Spine Navigation SystemAltus Partners, LLC · 2025
Show all 19 generations
- Root · 19 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 18 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
- 17 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
- 16 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
- 15 generations backK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
- 14 generations backK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
- 13 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
- 12 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
- 11 generations backK062174 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 10 generations backK063156 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 9 generations backK063741 Expedium Spine SystemDepuy Spine, Inc. · 2007
- 8 generations backK080313 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2008
- 7 generations backK101070 Expedium Spine SystemMedos International SARL · 2010 · Recalled
- 6 generations backK122226 Revere Stabilization SystemGlobus Medical, Inc. · 2012
- 5 generations backK124058 Creo Stabilization SystemGlobus Medical, Inc. · 2013
- 4 generations backK143633 CREO Stabilization SystemGlobus Medical, Inc. · 2015
- 3 generations backK180210 CREO® Stabilization SystemGlobus Medical, Inc. · 2018
- 2 generations backK182478 Whistler Modular Pedicle Screw SystemEvolution Spine, LLC · 2019
- 1 generation backK200922 Altus Spine HA Pedicle Screw SystemAltus Partners, LLC · 2021
- This deviceK211027 Altus Spine Pedicle Screw SystemAltus Partners, LLC · 2022
Class I recalls in this family
- K100952 Modification to Synthes Matrix System5 generations back · 2010
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −19 | K853033 | Hartshill Rect & Wires, Spinal Fixation System | A.W. Showell (Surgicraft), Ltd. | 1985 | — |
| −18 | K965221 | Ransford Cervical Fixation System | Surgicraft, Ltd. | 1997 | — |
| −17 | K982322 | Synthes Spine Occipital-Cervical Plate/Rod and Hook System | Synthes (Usa) | 1998 | — |
| −16 | K002733 | Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2000 | — |
| −15 | K013222 | Summit Occipito-Cervico- Thoracic (Oct) Spinal System | Depuyacromed | 2001 | — |
| −14 | K022190 | Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2002 | — |
| −13 | K030103 | Summit Oct Spinal System Minipolyaxial Screws | Depuyacromed | 2003 | — |
| −12 | K041203 | Summit Oct Spinal System | Depuy Spine, Inc. | 2004 | — |
| −11 | K062174 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| −10 | K063156 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| −9 | K063741 | Expedium Spine System | Depuy Spine, Inc. | 2007 | — |
| −8 | K080313 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2008 | — |
| −7 | K101070 | Expedium Spine System | Medos International SARL | 2010 | 1 |
| −6 | K122226 | Revere Stabilization System | Globus Medical, Inc. | 2012 | — |
| −5 | K124058 | Creo Stabilization System | Globus Medical, Inc. | 2013 | — |
| −4 | K143633 | CREO Stabilization System | Globus Medical, Inc. | 2015 | — |
| −3 | K180210 | CREO® Stabilization System | Globus Medical, Inc. | 2018 | — |
| −2 | K182478 | Whistler Modular Pedicle Screw System | Evolution Spine, LLC | 2019 | — |
| −1 | K200922 | Altus Spine HA Pedicle Screw System | Altus Partners, LLC | 2021 | — |
| 0 (this device) | K211027 | Altus Spine Pedicle Screw System | Altus Partners, LLC | 2022 | — |
| +1 | K230766 | Altus Spine Monaco Pedicle Screw System | Altus Spine | 2023 | — |
| +2 | K243419 | Altus Spine Navigation System | Altus Partners, LLC | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1984 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 6 | 0 |
| 1996 | 6 | 0 |
| 1997 | 5 | 0 |
| 1998 | 11 | 0 |
| 1999 | 10 | 0 |
| 2000 | 16 | 0 |
| 2001 | 19 | 0 |
| 2002 | 9 | 0 |
| 2003 | 14 | 0 |
| 2004 | 23 | 0 |
| 2005 | 24 | 0 |
| 2006 | 10 | 0 |
| 2007 | 11 | 0 |
| 2008 | 10 | 0 |
| 2009 | 11 | 0 |
| 2010 | 7 | 1 |
| 2011 | 5 | 0 |
| 2012 | 3 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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.
1 device in this family has a Class I recall. 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? (6)
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 |
|---|---|---|---|
| * | K200922 | Altus Spine HA Pedicle Screw SystemSummary page 4…, 2022 COMMON NAME: Uni-Planar Screw PROPRIETARY NAME: Altus Spine Pedicle Screw System PRIMARY PREDICATE DEVICES: Monaco HA Pedicle Screw System (K200922) ADDITIONAL PREDICATE DEVICES: Altus Spine Pedicle Screw System (K181339) Altus Spine Pedicle Scre… | 2021 |
| * | K181339 | Altus Spine Pedicle Screw SystemSummary page 4…: Altus Spine Pedicle Screw System PRIMARY PREDICATE DEVICES: Monaco HA Pedicle Screw System (K200922) ADDITIONAL PREDICATE DEVICES: Altus Spine Pedicle Screw System (K181339) Altus Spine Pedicle Screw System (K200322) Vertebron Pedicle Screw S… | 2018 |
| * | K200322 | Altus Spine Pedicle Screw SystemSummary page 4…Pedicle Screw System (K200922) ADDITIONAL PREDICATE DEVICES: Altus Spine Pedicle Screw System (K181339) Altus Spine Pedicle Screw System (K200322) Vertebron Pedicle Screw System (K033352) Zimmer Optima® ZS Spinal Ho… | 2020 |
| * | K033352 | Vertebron PSS Pedicle Screw SystemSummary page 4…ine Pedicle Screw System (K181339) Altus Spine Pedicle Screw System (K200322) Vertebron Pedicle Screw System (K033352) Zimmer Optima® ZS Spinal Hook System (K071880) Synthes Click’X® Mono… | 2004 |
| * | K071880 | Optima ZS Transition ScrewSummary page 4…Pedicle Screw System (K200322) Vertebron Pedicle Screw System (K033352) Zimmer Optima® ZS Spinal Hook System (K071880) Synthes Click’X® Monoaxial System(K031175) CLASSIFICATION NAME: 21 CFR §888.3070 Thraco… | 2007 |
| * | K031175 | Click'x Monoaxial Screws and HooksSummary page 4…dicle Screw System (K033352) Zimmer Optima® ZS Spinal Hook System (K071880) Synthes Click’X® Monoaxial System(K031175) CLASSIFICATION NAME: 21 CFR §888.3070 Thracolumbosacral Pedicle Screw Spinal System 2… | 2003 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K230766 | Altus Spine Monaco Pedicle Screw System | 2023 | 1 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K100952Modification to Synthes Matrix SystemSynthes Spine · 2010 · 5 generations back · ◆ in the 2010 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 37 years and passes through 9 companies; a new generation was cleared every 1.3 years on median.
- 18 of the 227 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K230766 (Altus Spine, 2023) has gone furthest, with 1 descendant of its own.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 and nonpedicle fixation for the following indications: degenerative disc disease (defined as back…
Read the full statement (180 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 and nonpedicle 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.
When used in a posterior percutaneous approach with MIS instrumentation, the Altus Spine Pedicle Screw System is intended for noncervical pedicle fixation and nonpedicle 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K211027 · printed Nov 4, 2026
Cite this page
510(k) Report. “K211027: 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/K211027
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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