510(k) · Cleared
ClearedSpinal Alignment Solutions Pelvic Incidence (PI) Rod System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spinal Alignment Solutions, Inc. · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Oct 28, 2024 as substantially equivalent to K113174 (Medtronic Sofamor Danek USA, Inc., 2011) and 2 other predicates after an 81-day review. Its family tree reaches back 23 generations to 1984. 1 later device descends from it.
- Decided
- Oct 28, 2024
- Review
- 81 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 23 generations to K841189 (1984). 556 ancestors in all, the oldest K781443 (1978). 1 later device descends from it, 1 citing it directly.
- Root · 23 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 19 generations between
- 3 generations backK172328 SOVEREIGN™ Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2017
- 2 generations backK191066 CD Horizon™ Astute™ Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2019
- 1 generation backK221646 CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion…Medtronic Sofamor Danek USA, Inc. · 2022
- This deviceK242350 Spinal Alignment Solutions Pelvic Incidence (PI) Rod SystemSpinal Alignment Solutions, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK263172 SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc. · 2026
Show all 23 generations
- Root · 23 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 22 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 21 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 20 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 19 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 18 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 17 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 16 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 15 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 14 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 13 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 12 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 11 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 10 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 9 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 8 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 7 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 6 generations backK153782 NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
- 5 generations backK161230 NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
- 4 generations backK170592 NuVasive BASE Interfixated Titanium SystemNu Vasive, Incorporated · 2017
- 3 generations backK172328 SOVEREIGN™ Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2017
- 2 generations backK191066 CD Horizon™ Astute™ Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2019
- 1 generation backK221646 CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion…Medtronic Sofamor Danek USA, Inc. · 2022
- This deviceK242350 Spinal Alignment Solutions Pelvic Incidence (PI) Rod SystemSpinal Alignment Solutions, Inc. · 2024
Most influential descendants
Showing 1 of 1 · See all- K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −23 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −22 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −21 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −20 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −19 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −18 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −17 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −16 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −15 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −14 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −13 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −12 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −11 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −10 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −9 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −8 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −7 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| −6 | K153782 | NuVasive® Lumbar Interbody Implants | Nu Vasive, Incorporated | 2016 | — |
| −5 | K161230 | NuVasive Lumbar Interbody Implants | Nu Vasive, Incorporated | 2016 | — |
| −4 | K170592 | NuVasive BASE Interfixated Titanium System | Nu Vasive, Incorporated | 2017 | — |
| −3 | K172328 | SOVEREIGN™ Spinal System | Medtronic Sofamor Danek USA, Inc. | 2017 | — |
| −2 | K191066 | CD Horizon™ Astute™ Spinal System | Medtronic Sofamor Danek USA, Inc. | 2019 | — |
| −1 | K221646 | CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD… | Medtronic Sofamor Danek USA, Inc. | 2022 | — |
| 0 (this device) | K242350 | Spinal Alignment Solutions Pelvic Incidence (PI) Rod System | Spinal Alignment Solutions, Inc. | 2024 | — |
| +1 | K263172 | SAS MIS Pelvic Incidence Rods | Spinal Alignment Solutions, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 2 | 0 |
| 1987 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 4 | 0 |
| 1995 | 7 | 0 |
| 1996 | 9 | 0 |
| 1997 | 7 | 0 |
| 1998 | 9 | 0 |
| 1999 | 8 | 0 |
| 2000 | 19 | 0 |
| 2001 | 24 | 0 |
| 2002 | 23 | 0 |
| 2003 | 31 | 0 |
| 2004 | 52 | 0 |
| 2005 | 37 | 0 |
| 2006 | 28 | 0 |
| 2007 | 25 | 0 |
| 2008 | 51 | 0 |
| 2009 | 30 | 0 |
| 2010 | 29 | 0 |
| 2011 | 28 | 0 |
| 2012 | 16 | 0 |
| 2013 | 20 | 0 |
| 2014 | 20 | 0 |
| 2015 | 17 | 0 |
| 2016 | 6 | 0 |
| 2017 | 8 | 0 |
| 2018 | 3 | 0 |
| 2019 | 3 | 0 |
| 2020 | 4 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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? (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 |
|---|---|---|---|
| * | K113174 | CD Horizon Spinal SystemSummary page 6…Solutions Pelvic Incidence (PI) Rod System is substantially equivalent to the following predicate devices: Primary Predicate: Medtronic CD Horizon™ Spinal System – K113174 Additional Predicates: Medtronic CD Horizon™ Spinal System - K202771; K221646 The Spinal Alignment Solutions Pelvic Incide… | 2011 |
| * | K202771 | CD Horizon Spinal SystemSummary page 6…he following predicate devices: Primary Predicate: Medtronic CD Horizon™ Spinal System – K113174 Additional Predicates: Medtronic CD Horizon™ Spinal System - K202771; K221646 The Spinal Alignment Solutions Pelvic Incidence (PI) Rod System indications for use are encompassed by the indications… | 2020 |
| * | K221646 | CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™…Summary page 6…ing predicate devices: Primary Predicate: Medtronic CD Horizon™ Spinal System – K113174 Additional Predicates: Medtronic CD Horizon™ Spinal System - K202771; K221646 The Spinal Alignment Solutions Pelvic Incidence (PI) Rod System indications for use are encompassed by the indications for use f… | 2022 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K263172 | SAS MIS Pelvic Incidence Rods | 2026 | 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 40 years and passes through 13 companies; a new generation was cleared every 11 months on median.
- 57 of the 556 ancestors have a recall of any class.
- Of its descendants, K263172 (Spinal Alignment Solutions, Inc., 2026) has gone furthest, with 0 descendants of its own.
- 36 other devices also cite its predicate K113174.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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 Spinal Alignment Solutions Pelvic Incidence (PI) Rod System is indicated for the use with Medtronic CD Horizon™ SOLERA™ Spinal System which is intended for posterior, lumbar and sacral fixation in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (DDD - 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, or lordosis), tumor, pseudarthrosis, and/or failed previous fusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K242350 · printed Nov 6, 2026
Cite this page
510(k) Report. “K242350: Spinal Alignment Solutions Pelvic Incidence (PI) Rod System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K242350
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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