510(k) · Cleared
ClearedErisma® Lp Spinal Fixation System; Erisma® LP MIS
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Clariance · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Jul 24, 2024 as substantially equivalent to K240872 (Clariance, 2024) and 1 other predicate after a 27-day review. Its family tree reaches back 26 generations to 1985. 2 of the 610 devices in its family, counting itself, have a Class I recall.
- Decided
- Jul 24, 2024
- Review
- 27 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 26 generations to K853033 (1985). 609 ancestors in all, the oldest K761228 (1976). No later device cites it as a predicate yet. 2 of the 610 devices in this family, counting this one, have a Class I recall.
- Root · 26 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 22 generations between
- 3 generations backK181603 EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System…K2m, Inc. · 2018
- 2 generations backK222684 XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal…Stryker Spine · 2023
- 1 generation backK240872 Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance · 2024
- This deviceK241863 Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance · 2024
Show all 26 generations
- Root · 26 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 25 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
- 24 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
- 23 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
- 22 generations backK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
- 21 generations backK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
- 20 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
- 19 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
- 18 generations backK062174 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 17 generations backK063156 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 16 generations backK063741 Expedium Spine SystemDepuy Spine, Inc. · 2007
- 15 generations backK080313 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2008
- 14 generations backK111571 Viper SystemsJohnson & Johnson · 2011
- 13 generations backK121016 Range Spinal System (Mesa and Denali)K2m, Inc. · 2012
- 12 generations backK130330 Range Spinal SystemK2m, Inc. · 2013
- 11 generations backK131784 Range Spinal SystemK2m, Inc. · 2013
- 10 generations backK133944 Range, Spinal System, Everest Spinal SystemK2m, Inc. · 2014
- 9 generations backK141873 Range/Mesa/Denali Spinal SystemK2m, Inc. · 2014
- 8 generations backK143334 Range/Denali/Mesa Spinal SystemK2m, Inc. · 2015
- 7 generations backK150325 Range/Denali/Mesa Spinal SystemK2m, Inc. · 2015
- 6 generations backK151727 Everest Spinal SystemK2m, Inc. · 2015
- 5 generations backK161369 EVEREST Spinal SystemK2m, Incorporated · 2016
- 4 generations backK181188 EVEREST Spinal SystemK2m, Inc. · 2018
- 3 generations backK181603 EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System…K2m, Inc. · 2018
- 2 generations backK222684 XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal…Stryker Spine · 2023
- 1 generation backK240872 Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance · 2024
- This deviceK241863 Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance · 2024
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −26 | K853033 | Hartshill Rect & Wires, Spinal Fixation System | A.W. Showell (Surgicraft), Ltd. | 1985 | — |
| −25 | K965221 | Ransford Cervical Fixation System | Surgicraft, Ltd. | 1997 | — |
| −24 | K982322 | Synthes Spine Occipital-Cervical Plate/Rod and Hook System | Synthes (Usa) | 1998 | — |
| −23 | K002733 | Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2000 | — |
| −22 | K013222 | Summit Occipito-Cervico- Thoracic (Oct) Spinal System | Depuyacromed | 2001 | — |
| −21 | K022190 | Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2002 | — |
| −20 | K030103 | Summit Oct Spinal System Minipolyaxial Screws | Depuyacromed | 2003 | — |
| −19 | K041203 | Summit Oct Spinal System | Depuy Spine, Inc. | 2004 | — |
| −18 | K062174 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| −17 | K063156 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| −16 | K063741 | Expedium Spine System | Depuy Spine, Inc. | 2007 | — |
| −15 | K080313 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2008 | — |
| −14 | K111571 | Viper Systems | Johnson & Johnson | 2011 | — |
| −13 | K121016 | Range Spinal System (Mesa and Denali) | K2m, Inc. | 2012 | — |
| −12 | K130330 | Range Spinal System | K2m, Inc. | 2013 | — |
| −11 | K131784 | Range Spinal System | K2m, Inc. | 2013 | — |
| −10 | K133944 | Range, Spinal System, Everest Spinal System | K2m, Inc. | 2014 | — |
| −9 | K141873 | Range/Mesa/Denali Spinal System | K2m, Inc. | 2014 | — |
| −8 | K143334 | Range/Denali/Mesa Spinal System | K2m, Inc. | 2015 | — |
| −7 | K150325 | Range/Denali/Mesa Spinal System | K2m, Inc. | 2015 | — |
| −6 | K151727 | Everest Spinal System | K2m, Inc. | 2015 | — |
| −5 | K161369 | EVEREST Spinal System | K2m, Incorporated | 2016 | — |
| −4 | K181188 | EVEREST Spinal System | K2m, Inc. | 2018 | — |
| −3 | K181603 | EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT… | K2m, Inc. | 2018 | — |
| −2 | K222684 | XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System… | Stryker Spine | 2023 | — |
| −1 | K240872 | Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation System | Clariance | 2024 | — |
| 0 (this device) | K241863 | Erisma® Lp Spinal Fixation System; Erisma® LP MIS | Clariance | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1976 | 1 | 0 |
| 1978 | 1 | 0 |
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 2 | 0 |
| 1988 | 1 | 0 |
| 1990 | 3 | 0 |
| 1991 | 1 | 0 |
| 1992 | 6 | 0 |
| 1993 | 6 | 0 |
| 1994 | 4 | 0 |
| 1995 | 9 | 0 |
| 1996 | 11 | 0 |
| 1997 | 8 | 0 |
| 1998 | 14 | 0 |
| 1999 | 15 | 0 |
| 2000 | 20 | 0 |
| 2001 | 35 | 0 |
| 2002 | 26 | 0 |
| 2003 | 33 | 0 |
| 2004 | 58 | 0 |
| 2005 | 45 | 0 |
| 2006 | 33 | 0 |
| 2007 | 31 | 0 |
| 2008 | 43 | 1 |
| 2009 | 34 | 0 |
| 2010 | 26 | 1 |
| 2011 | 32 | 0 |
| 2012 | 25 | 0 |
| 2013 | 17 | 0 |
| 2014 | 11 | 0 |
| 2015 | 17 | 0 |
| 2016 | 5 | 0 |
| 2017 | 7 | 0 |
| 2020 | 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.
2 devices in this family have 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? (2)
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 |
|---|---|---|---|
| * | K240872 | Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemSummary page 4…dicle screw system Classification Name: Class II, 21 CFR 888.3070 – NKB Predicate Devices Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation System (K240872) Primary predicate. Erisma® LP MIS (K162367) Additional predicate Device Description The modified Erisma® Lp Spinal Fix… | 2024 |
| * | K162367 | Erisma® LP MISSummary page 4…II, 21 CFR 888.3070 – NKB Predicate Devices Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation System (K240872) Primary predicate. Erisma® LP MIS (K162367) Additional predicate Device Description The modified Erisma® Lp Spinal Fixation System device is designed for use in the surgi… | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (2 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.
What does this lineage say?
- The line of descent spans 39 years and passes through 10 companies; a new generation was cleared every 10 months on median.
- 69 of the 609 ancestors have a recall of any class; 2 have a Class I recall.
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?
When used as a pedicle screw fixation system of the non- cervical posterior spine in skeletally mature patients using allograft and/or autograft, the Erisma® LP Spinal System is indicated as an adjunct to fusion for the following indications: Degenerative Disc Disease (Define as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); degenerative spondylolisthesis with objective evidence of neurologic…
Read the full statement (190 words)
When used as a pedicle screw fixation system of the non- cervical posterior spine in skeletally mature patients using allograft and/or autograft, the Erisma® LP Spinal System is indicated as an adjunct to fusion for the following indications: Degenerative Disc Disease (Define as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); degenerative spondylolisthesis with objective evidence of neurologic impairment; severe spondylolisthesis (grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint; fracture; dislocation; scoliosis; kyphosis; spinal tumor; failed previous fusion (pseudarthrosis)
The Erisma® LP MIS components are intended for percutaneous, posterior, non-cervical pedicle fixation of the spine to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion for the following indications:
• Degenerative disc disease (Define as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies),
• Degenerative spondylolisthesis with objective evidence of neurologic impairment,
• Severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint,
• Fracture,
• Dislocation,
• Scoliosis,
• Kyphosis,
• Spinal tumor,
• Failed previous fusion (pseudarthrosis).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K241863 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241863: Erisma® Lp Spinal Fixation System; Erisma® LP MIS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K241863
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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