510(k) · Cleared
ClearedCannulated Power Driver Attachment
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
K2m, Inc. · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Oct 26, 2020 as substantially equivalent to K200666 (Stryker Spine, 2020) and 6 other predicates after a 55-day review. Its family tree reaches back 20 generations to 2004.
- Decided
- Oct 26, 2020
- Review
- 55 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 20 generations to K040583 (2004). 180 ancestors in all, the oldest K781443 (1978). No later device cites it as a predicate yet.
- Root · 20 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 16 generations between
- 3 generations backK152632 XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument AccessoryStryker Corporation · 2015
- 2 generations backK170496 Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument AccessoryStryker Corporation · 2017 · Recalled
- 1 generation backK200666 Stryker Xia 3 Power AdaptorStryker Spine · 2020
- This deviceK202528 Cannulated Power Driver AttachmentK2m, Inc. · 2020
Show all 20 generations
- Root · 20 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 19 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 18 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
- 17 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 16 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
- 15 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 14 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
- 13 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
- 12 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
- 11 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
- 10 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
- 9 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
- 8 generations backK121680 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
- 7 generations backK131321 CD Horizon Spinal SystemMedtronic Sofamor Danek USA · 2013
- 6 generations backK132471 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2013
- 5 generations backK140276 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2014
- 4 generations backK142381 Xia 3 Spinal SystemStryker Corp. · 2014
- 3 generations backK152632 XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument AccessoryStryker Corporation · 2015
- 2 generations backK170496 Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument AccessoryStryker Corporation · 2017 · Recalled
- 1 generation backK200666 Stryker Xia 3 Power AdaptorStryker Spine · 2020
- This deviceK202528 Cannulated Power Driver AttachmentK2m, Inc. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −20 | K040583 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −19 | K041118 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −18 | K042025 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2004 | 4 |
| −17 | K043151 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −16 | K050809 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2005 | — |
| −15 | K052187 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −14 | K053101 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −13 | K091442 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2009 | — |
| −12 | K091974 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2009 | 1 |
| −11 | K102555 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2010 | — |
| −10 | K112473 | CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2011 | — |
| −9 | K113174 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2011 | 1 |
| −8 | K121680 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2012 | — |
| −7 | K131321 | CD Horizon Spinal System | Medtronic Sofamor Danek USA | 2013 | — |
| −6 | K132471 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2013 | — |
| −5 | K140276 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2014 | — |
| −4 | K142381 | Xia 3 Spinal System | Stryker Corp. | 2014 | — |
| −3 | K152632 | XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument Accessory | Stryker Corporation | 2015 | — |
| −2 | K170496 | Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument Accessory | Stryker Corporation | 2017 | 1 |
| −1 | K200666 | Stryker Xia 3 Power Adaptor | Stryker Spine | 2020 | — |
| 0 (this device) | K202528 | Cannulated Power Driver Attachment | K2m, Inc. | 2020 | — |
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 | 3 | 0 |
| 1996 | 3 | 0 |
| 1997 | 3 | 0 |
| 1998 | 4 | 0 |
| 1999 | 4 | 0 |
| 2000 | 12 | 0 |
| 2001 | 13 | 0 |
| 2002 | 7 | 0 |
| 2003 | 11 | 0 |
| 2004 | 19 | 0 |
| 2005 | 19 | 0 |
| 2006 | 14 | 0 |
| 2007 | 7 | 0 |
| 2008 | 8 | 0 |
| 2009 | 7 | 0 |
| 2010 | 9 | 0 |
| 2011 | 6 | 0 |
| 2012 | 4 | 0 |
| 2013 | 2 | 0 |
| 2017 | 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? (7)
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 |
|---|---|---|---|
| * | K200666 | Stryker Xia 3 Power AdaptorSummary page 4…ss II Classification Name: Thoracolumbosacral Pedicle Screw System Regulation Number: 888.3070 Product Code: NKB Predicate Device: Primary Predicate: K200666 Additional Predicates: K172724, K170496, K152632, K120434, K122845, K111478 Device Description: This… | 2020 |
| * | K172724 | XIA® 4.5 Spinal System, Power Adaptor Instrument AccessorySummary page 4…Screw System Regulation Number: 888.3070 Product Code: NKB Predicate Device: Primary Predicate: K200666 Additional Predicates: K172724, K170496, K152632, K120434, K122845, K111478 Device Description: This traditional 510(k) premarket notification is to introdu… | 2017 |
| * | K170496 | Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument AccessorySummary page 4…stem Regulation Number: 888.3070 Product Code: NKB Predicate Device: Primary Predicate: K200666 Additional Predicates: K172724, K170496, K152632, K120434, K122845, K111478 Device Description: This traditional 510(k) premarket notification is to introduce the Ca… | 2017 |
| * | K152632 | XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument AccessorySummary page 4…lation Number: 888.3070 Product Code: NKB Predicate Device: Primary Predicate: K200666 Additional Predicates: K172724, K170496, K152632, K120434, K122845, K111478 Device Description: This traditional 510(k) premarket notification is to introduce the Cannulated… | 2015 |
| * | K120434 | Power Adaptor Instrument AccessorySummary page 4…mber: 888.3070 Product Code: NKB Predicate Device: Primary Predicate: K200666 Additional Predicates: K172724, K170496, K152632, K120434, K122845, K111478 Device Description: This traditional 510(k) premarket notification is to introduce the Cannulated Power… | 2012 |
| * | K122845 | ES2 Spinal System Model 48280XXXXSummary page 4…888.3070 Product Code: NKB Predicate Device: Primary Predicate: K200666 Additional Predicates: K172724, K170496, K152632, K120434, K122845, K111478 Device Description: This traditional 510(k) premarket notification is to introduce the Cannulated Power… | 2012 |
| * | K111478 | Stryker Spine Power Adaptor (Accessory Instrument)Summary page 4…Product Code: NKB Predicate Device: Primary Predicate: K200666 Additional Predicates: K172724, K170496, K152632, K120434, K122845, K111478 Device Description: This traditional 510(k) premarket notification is to introduce the Cannulated Power… | 2011 |
What descends from it?
No later submission names this one as a predicate yet.
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 16 years and passes through 8 companies; a new generation was cleared every 6 months on median.
- 25 of the 180 ancestors have a recall of any class.
- 1 other device also cites its predicate K200666.
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 MESA and DENALI Spinal Systems (including ARI Staples) and the EVEREST Spinal System are cleared for the following indications: Posterior non-cervical fixation as an adjunct to fusion for the following indications: degenerative disc disease (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.…
Read the full statement (162 words)
The MESA and DENALI Spinal Systems (including ARI Staples) and the EVEREST Spinal System are cleared for the following indications:
Posterior non-cervical fixation as an adjunct to fusion for the following indications: degenerative disc disease (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; pseudoarthosis; and/or failed previous fusion.
Except for hooks, when used as an anterolateral thoracic/lumbar system the Range Spinal System may also be used for the same indications as an adjunct to fusion.
Except for the ARI staples, the MESA, DENALI and EVEREST Spinal Systems are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis when used for posterior non-cervical fixation in pediatric patients. The MESA, DENALI and EVEREST Spinal System for pediatric use is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K202528 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202528: Cannulated Power Driver Attachment.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K202528
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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