510(k) · Cleared
ClearedErisma® LP MIS
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Clariance, Sas · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Oct 27, 2016 as substantially equivalent to K153326 (Clariance, Sas, 2016) and 1 other predicate after a 65-day review. Its family tree reaches back 9 generations to 1995. 2 later devices descend from it.
- Decided
- Oct 27, 2016
- Review
- 65 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K950697 (1995). 64 ancestors in all, the oldest K944736 (1995). 2 later devices descend from it, 2 citing it directly.
- Root · 9 generations backK950697 Depuy Motech Moss Miami Spinal System - Pedicle FixationDepuy Motech · 1995
- 5 generations between
- 3 generations backK092631 Mantis Redux Spinal SystemStryker Spine · 2009
- 2 generations backK102235 Mantis Spinal System & Mantis Redux Spinal SystemStryker Spine · 2010
- 1 generation backK122845 ES2 Spinal System Model 48280XXXXStryker Spine · 2012
- This deviceK162367 Erisma® LP MISClariance, Sas · 2016
- Descendant · cites it directly · 0 of its ownK241863 Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance · 2024
- Descendant · cites it directly · 0 of its ownK191810 Curiteva Pedicle Screw SystemCuriteva, Inc. · 2019
Show all 9 generations
- Root · 9 generations backK950697 Depuy Motech Moss Miami Spinal System - Pedicle FixationDepuy Motech · 1995
- 8 generations backK050461 Xia 4.5 Spinal SystemStryker Spine · 2005
- 7 generations backK052761 Modification to: Xia 4.5 Spinal SystemStryker Spine · 2005
- 6 generations backK060361 Xia Spinal System, Xia 4.5 Spinal SystemStryker Spine · 2006 · Recalled
- 5 generations backK061854 Xia Titanium Spinal System and Xia Stainless Steel Spinal SystemStryker Spine · 2006
- 4 generations backK063428 Xia Stainless Steel Spinal SystemStryker Spine · 2006
- 3 generations backK092631 Mantis Redux Spinal SystemStryker Spine · 2009
- 2 generations backK102235 Mantis Spinal System & Mantis Redux Spinal SystemStryker Spine · 2010
- 1 generation backK122845 ES2 Spinal System Model 48280XXXXStryker Spine · 2012
- This deviceK162367 Erisma® LP MISClariance, Sas · 2016
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K950697 | Depuy Motech Moss Miami Spinal System - Pedicle Fixation | Depuy Motech | 1995 | — |
| −8 | K050461 | Xia 4.5 Spinal System | Stryker Spine | 2005 | — |
| −7 | K052761 | Modification to: Xia 4.5 Spinal System | Stryker Spine | 2005 | — |
| −6 | K060361 | Xia Spinal System, Xia 4.5 Spinal System | Stryker Spine | 2006 | 1 |
| −5 | K061854 | Xia Titanium Spinal System and Xia Stainless Steel Spinal System | Stryker Spine | 2006 | — |
| −4 | K063428 | Xia Stainless Steel Spinal System | Stryker Spine | 2006 | — |
| −3 | K092631 | Mantis Redux Spinal System | Stryker Spine | 2009 | — |
| −2 | K102235 | Mantis Spinal System & Mantis Redux Spinal System | Stryker Spine | 2010 | — |
| −1 | K122845 | ES2 Spinal System Model 48280XXXX | Stryker Spine | 2012 | — |
| 0 (this device) | K162367 | Erisma® LP MIS | Clariance, Sas | 2016 | — |
| +1 | K241863 | Erisma® Lp Spinal Fixation System; Erisma® LP MIS | Clariance | 2024 | — |
| +1 | K191810 | Curiteva Pedicle Screw System | Curiteva, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 5 | 0 |
| 1999 | 4 | 0 |
| 2000 | 5 | 0 |
| 2001 | 6 | 0 |
| 2002 | 4 | 0 |
| 2003 | 7 | 0 |
| 2004 | 5 | 0 |
| 2005 | 5 | 0 |
| 2006 | 4 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2012 | 1 | 0 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2024 | 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? (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 |
|---|---|---|---|
| * | K153326 | Erisma-LP Spinal Fixation SystemSummary page 4…Pedicle Screw Spinal System Class III, 21 CFR 888.3070 – NKB, MNH and MNI Predicate Devices Erisma LP Spinal Fixation System Manufactured by CLARIANCE SAS (K153326) (Primary predicate device) ES2 Spinal System Manufactured by STRYKER Spine (K122845) (Additional predicate devic… | 2016 |
| * | K122845 | ES2 Spinal System Model 48280XXXXSummary page 4…ces Erisma LP Spinal Fixation System Manufactured by CLARIANCE SAS (K153326) (Primary predicate device) ES2 Spinal System Manufactured by STRYKER Spine (K122845) (Additional predicate device) Indications for Use The Erisma® LP MIS components are intended for percutaneous, posterior,… | 2012 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 21 years and passes through 3 companies; a new generation was cleared every 11 months on median.
- 5 of the 64 ancestors have a recall of any class.
- Of its descendants, K241863 (Clariance, 2024) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K153326.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 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…
Read the full statement (99 words)
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/K162367 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162367: 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/K162367
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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