510(k) · Cleared
ClearedWhistler Modular Pedicle Screw System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Evolution Spine, LLC · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Jan 15, 2019 as substantially equivalent to K180210 (Globus Medical, Inc., 2018) after a 127-day review. Its family tree reaches back 17 generations to 1985. 1 of the 194 devices in its family, counting itself, has a Class I recall. 6 later devices descend from it.
- Decided
- Jan 15, 2019
- Review
- 127 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 17 generations to K853033 (1985). 187 ancestors in all, the oldest K781443 (1978). 6 later devices descend from it, 2 citing it directly. 1 of the 194 devices in this family, counting this one, has a Class I recall.
- Root · 17 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 13 generations between
- 3 generations backK124058 Creo Stabilization SystemGlobus Medical, Inc. · 2013
- 2 generations backK143633 CREO Stabilization SystemGlobus Medical, Inc. · 2015
- 1 generation backK180210 CREO® Stabilization SystemGlobus Medical, Inc. · 2018
- This deviceK182478 Whistler Modular Pedicle Screw SystemEvolution Spine, LLC · 2019
- Descendant · cites it directly · 3 of its ownK200922 Altus Spine HA Pedicle Screw SystemAltus Partners, LLC · 2021
- Descendant · 2 generations on · 2 of its ownK211027 Altus Spine Pedicle Screw SystemAltus Partners, LLC · 2022
- Descendant · cites it directly · 1 of its ownK234048 M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A. · 2024
- Descendant · 3 generations on · 1 of its ownK230766 Altus Spine Monaco Pedicle Screw SystemAltus Spine · 2023
- Descendant · 2 generations on · 0 of its ownK253940 M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A. · 2026
Show all 17 generations
- Root · 17 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 16 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
- 15 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
- 14 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
- 13 generations backK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
- 12 generations backK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
- 11 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
- 10 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
- 9 generations backK062174 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 8 generations backK063156 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 7 generations backK063741 Expedium Spine SystemDepuy Spine, Inc. · 2007
- 6 generations backK080313 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2008
- 5 generations backK101070 Expedium Spine SystemMedos International SARL · 2010 · Recalled
- 4 generations backK122226 Revere Stabilization SystemGlobus Medical, Inc. · 2012
- 3 generations backK124058 Creo Stabilization SystemGlobus Medical, Inc. · 2013
- 2 generations backK143633 CREO Stabilization SystemGlobus Medical, Inc. · 2015
- 1 generation backK180210 CREO® Stabilization SystemGlobus Medical, Inc. · 2018
- This deviceK182478 Whistler Modular Pedicle Screw SystemEvolution Spine, LLC · 2019
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K100952 Modification to Synthes Matrix System3 generations back · 2010
Most influential descendants
Showing 5 of 6 · See all- K200922Altus Spine HA Pedicle Screw SystemAltus Partners, LLC · 2021 · cites it directly3descendants
- K211027Altus Spine Pedicle Screw SystemAltus Partners, LLC · 2022 · 2 generations on2descendants
- K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A. · 2024 · cites it directly1descendant
- K230766Altus Spine Monaco Pedicle Screw SystemAltus Spine · 2023 · 3 generations on1descendant
- K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A. · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K853033 | Hartshill Rect & Wires, Spinal Fixation System | A.W. Showell (Surgicraft), Ltd. | 1985 | — |
| −16 | K965221 | Ransford Cervical Fixation System | Surgicraft, Ltd. | 1997 | — |
| −15 | K982322 | Synthes Spine Occipital-Cervical Plate/Rod and Hook System | Synthes (Usa) | 1998 | — |
| −14 | K002733 | Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2000 | — |
| −13 | K013222 | Summit Occipito-Cervico- Thoracic (Oct) Spinal System | Depuyacromed | 2001 | — |
| −12 | K022190 | Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2002 | — |
| −11 | K030103 | Summit Oct Spinal System Minipolyaxial Screws | Depuyacromed | 2003 | — |
| −10 | K041203 | Summit Oct Spinal System | Depuy Spine, Inc. | 2004 | — |
| −9 | K062174 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| −8 | K063156 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| −7 | K063741 | Expedium Spine System | Depuy Spine, Inc. | 2007 | — |
| −6 | K080313 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2008 | — |
| −5 | K101070 | Expedium Spine System | Medos International SARL | 2010 | 1 |
| −4 | K122226 | Revere Stabilization System | Globus Medical, Inc. | 2012 | — |
| −3 | K124058 | Creo Stabilization System | Globus Medical, Inc. | 2013 | — |
| −2 | K143633 | CREO Stabilization System | Globus Medical, Inc. | 2015 | — |
| −1 | K180210 | CREO® Stabilization System | Globus Medical, Inc. | 2018 | — |
| 0 (this device) | K182478 | Whistler Modular Pedicle Screw System | Evolution Spine, LLC | 2019 | — |
| +1 | K200922 | Altus Spine HA Pedicle Screw System | Altus Partners, LLC | 2021 | — |
| +2 | K211027 | Altus Spine Pedicle Screw System | Altus Partners, LLC | 2022 | — |
| +1 | K234048 | M.U.S.T. Pedicle Screw System - Extension | Medacta International S.A. | 2024 | — |
| +3 | K230766 | Altus Spine Monaco Pedicle Screw System | Altus Spine | 2023 | — |
| +2 | K253940 | M.U.S.T. Pedicle Screw System - Extension | Medacta International S.A. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1984 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 4 | 0 |
| 1996 | 5 | 0 |
| 1997 | 4 | 0 |
| 1998 | 7 | 0 |
| 1999 | 8 | 0 |
| 2000 | 11 | 0 |
| 2001 | 17 | 0 |
| 2002 | 7 | 0 |
| 2003 | 11 | 0 |
| 2004 | 21 | 0 |
| 2005 | 21 | 0 |
| 2006 | 9 | 0 |
| 2007 | 8 | 0 |
| 2008 | 9 | 0 |
| 2009 | 11 | 0 |
| 2010 | 6 | 1 |
| 2011 | 4 | 0 |
| 2012 | 2 | 0 |
| 2017 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 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.
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? (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 |
|---|---|---|---|
| * | K180210 | CREO® Stabilization SystemSummary page 4…rew System Regulatory Class: 2 Regulation Number: 21 CFR 888.3070 Product Code: NKB III. PREDICATE DEVICES CREO Stabilization System (K180210)- primary predicate Modera Modular Pedicle Screw System (K141253)- reference predicate U&I Corporation OPTIMA Ped… | 2018 |
| † | K141253 | New Era Orthopaedics Polyscrew Pedicle Screw System | 2015 |
| † | K031585 | U&I, Optima, Spinal System | 2003 |
| † | K973836 | Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the Cross Medical-Synergy… | 1998 |
| † | K962628 | Moss Miami Spinal System | 1997 |
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? (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 · 3 generations back · ◆ in the 2010 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 34 years and passes through 8 companies; a new generation was cleared every 1.3 years on median.
- 16 of the 187 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K200922 (Altus Partners, LLC, 2021) has gone furthest, with 3 descendants of its own.
- 4 other devices also cite its predicate K180210.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 Whistler Modular 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 the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine: 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, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K182478 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182478: Whistler Modular 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/K182478
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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