510(k) · Cleared
ClearedK2M Modular Hooks
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 Jul 30, 2014 as substantially equivalent to K052398 (K2m, LLC, 2005) and 4 other predicates after a 266-day review. Its family tree reaches back 18 generations to 1985.
- Decided
- Jul 30, 2014
- Review
- 266 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 18 generations to K853033 (1985). 316 ancestors in all, the oldest K781443 (1978). No later device cites it as a predicate yet.
- Root · 18 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 14 generations between
- 3 generations backK131784 Range Spinal SystemK2m, Inc. · 2013
- 2 generations backK133944 Range, Spinal System, Everest Spinal SystemK2m, Inc. · 2014
- 1 generation backK141147 Range Spinal SystemK2m, Inc. · 2014
- This deviceK133402 K2M Modular HooksK2m, Inc. · 2014
Show all 18 generations
- Root · 18 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 17 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
- 16 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
- 15 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
- 14 generations backK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
- 13 generations backK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
- 12 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
- 11 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
- 10 generations backK062174 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 9 generations backK063156 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 8 generations backK063741 Expedium Spine SystemDepuy Spine, Inc. · 2007
- 7 generations backK080313 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2008
- 6 generations backK111571 Viper SystemsJohnson & Johnson · 2011
- 5 generations backK121016 Range Spinal System (Mesa and Denali)K2m, Inc. · 2012
- 4 generations backK130330 Range Spinal SystemK2m, Inc. · 2013
- 3 generations backK131784 Range Spinal SystemK2m, Inc. · 2013
- 2 generations backK133944 Range, Spinal System, Everest Spinal SystemK2m, Inc. · 2014
- 1 generation backK141147 Range Spinal SystemK2m, Inc. · 2014
- This deviceK133402 K2M Modular HooksK2m, Inc. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −18 | K853033 | Hartshill Rect & Wires, Spinal Fixation System | A.W. Showell (Surgicraft), Ltd. | 1985 | — |
| −17 | K965221 | Ransford Cervical Fixation System | Surgicraft, Ltd. | 1997 | — |
| −16 | K982322 | Synthes Spine Occipital-Cervical Plate/Rod and Hook System | Synthes (Usa) | 1998 | — |
| −15 | K002733 | Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2000 | — |
| −14 | K013222 | Summit Occipito-Cervico- Thoracic (Oct) Spinal System | Depuyacromed | 2001 | — |
| −13 | K022190 | Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2002 | — |
| −12 | K030103 | Summit Oct Spinal System Minipolyaxial Screws | Depuyacromed | 2003 | — |
| −11 | K041203 | Summit Oct Spinal System | Depuy Spine, Inc. | 2004 | — |
| −10 | K062174 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| −9 | K063156 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| −8 | K063741 | Expedium Spine System | Depuy Spine, Inc. | 2007 | — |
| −7 | K080313 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2008 | — |
| −6 | K111571 | Viper Systems | Johnson & Johnson | 2011 | — |
| −5 | K121016 | Range Spinal System (Mesa and Denali) | K2m, Inc. | 2012 | — |
| −4 | K130330 | Range Spinal System | K2m, Inc. | 2013 | — |
| −3 | K131784 | Range Spinal System | K2m, Inc. | 2013 | — |
| −2 | K133944 | Range, Spinal System, Everest Spinal System | K2m, Inc. | 2014 | — |
| −1 | K141147 | Range Spinal System | K2m, Inc. | 2014 | — |
| 0 (this device) | K133402 | K2M Modular Hooks | K2m, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1984 | 1 | 0 |
| 1990 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 5 | 0 |
| 1996 | 8 | 0 |
| 1997 | 4 | 0 |
| 1998 | 11 | 0 |
| 1999 | 12 | 0 |
| 2000 | 18 | 0 |
| 2001 | 28 | 0 |
| 2002 | 18 | 0 |
| 2003 | 20 | 0 |
| 2004 | 40 | 0 |
| 2005 | 30 | 0 |
| 2006 | 17 | 0 |
| 2007 | 14 | 0 |
| 2008 | 18 | 0 |
| 2009 | 12 | 0 |
| 2010 | 10 | 0 |
| 2011 | 14 | 0 |
| 2012 | 8 | 0 |
| 2013 | 6 | 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? (5)
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 |
|---|---|---|---|
| * | K052398 | Mesa Spinal SystemSummary page 1…ed from titanium alloy (Ti-6A1-4V ELI) as described by ASTM and ISO standards. Predicate Devices: K2M MESA® Spinal System (K052398/K08061 1) K2M Range (Mesa/Denali) Spinal System (K141147) Medtronic CID Horizon (K962… | 2005 |
| * | K080611 | Mesa Spinal SystemSummary page 1…titanium alloy (Ti-6A1-4V ELI) as described by ASTM and ISO standards. Predicate Devices: K2M MESA® Spinal System (K052398/K08061 1) K2M Range (Mesa/Denali) Spinal System (K141147) Medtronic CID Horizon (K9627081K0316… | 2009 |
| * | K141147 | Range Spinal System Cleared while this submission was under review Summary page 1…TM and ISO standards. Predicate Devices: K2M MESA® Spinal System (K052398/K08061 1) K2M Range (Mesa/Denali) Spinal System (K141147) Medtronic CID Horizon (K9627081K031655)… | 2014 |
| * | K962708 | Titanium CD Horizon Spinal SystemSummary page 1…Devices: K2M MESA® Spinal System (K052398/K08061 1) K2M Range (Mesa/Denali) Spinal System (K141147) Medtronic CID Horizon (K9627081K031655) K1 33402… | 1997 |
| * | K031655 | CD Horizon Spinal SystemSummary page 1…K2M MESA® Spinal System (K052398/K08061 1) K2M Range (Mesa/Denali) Spinal System (K141147) Medtronic CID Horizon (K9627081K031655) K1 33402… | 2003 |
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 29 years and passes through 7 companies; a new generation was cleared every 11 months on median.
- 29 of the 316 ancestors have a recall of any class.
- 16 other devices also cite its predicate K052398.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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?
RANGE/DENALI/MESA and SMALL STATURE and ARI are cleared for the following indications: 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); spondylol isthles is; trauma (i.e.. fracture or dislocation): spinal stenIosis; Curvatures (i.e.. scoliosis. kyphosis. and/or lordosis); tumor…
Read the full statement (149 words)
RANGE/DENALI/MESA and SMALL STATURE and ARI are cleared for the following indications:
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); spondylol isthles is; trauma (i.e.. fracture or dislocation): spinal stenIosis; Curvatures (i.e.. scoliosis. kyphosis. and/or lordosis); tumor; pseudarthrosis; 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 Range Spinal System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis when used for posterior nonicervical fixation in pediatric patients. The Range Spinal System for pediatric use is intended to be used with autograft and/or allografi. Pediatric pedicle screw fixation is limited to a posterior approach.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133402 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133402: K2M Modular Hooks.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133402
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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