510(k) · Cleared
Recalled · Class III · 2019Erisma-LP Spinal Fixation System
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 Mar 8, 2016 as substantially equivalent to K120469 (Clariance, 2012) after a 110-day review. Its family tree reaches back 6 generations to 1995. 5 later devices descend from it. It has been recalled once.
- Decided
- Mar 8, 2016
- Review
- 110 days
- Class
- Class II
- Product code
- NKB
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 6 generations to K944736 (1995). 18 ancestors in all. 5 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK944736 VSP (Variable Screw Placement)Acromed Corp. · 1995
- 5 generations backK981274 Acromed Timx Plate Based Low Back SystemAcromed Corp. · 1998
- 4 generations backK010576 Monarch Spine SystemDepuyacromed · 2001
- 3 generations backK021148 Monarch Spine System Commercially Pure Titanium Spinal RodDepuyacromed · 2002
- 2 generations backK052131 Expedium Spine System 5.5MM Commerically Pure Titanium Spinal RodsDepuy Spine, Inc. · 2005
- 1 generation backK120469 Erisma-LPClariance · 2012
- This deviceK153326 Erisma-LP Spinal Fixation SystemClariance, Sas · 2016
- Descendant · cites it directly · 2 of its ownK170163 Erisma® LP Spinal Fixation SystemClariance, Sas · 2017
- Descendant · cites it directly · 2 of its ownK162367 Erisma® LP MISClariance, Sas · 2016
- Descendant · 2 generations on · 1 of its ownK240872 Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance · 2024
- Descendant · 2 generations on · 0 of its ownK241863 Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance · 2024
- Descendant · 2 generations on · 0 of its ownK191810 Curiteva Pedicle Screw SystemCuriteva, Inc. · 2019
Most influential descendants
Showing 5 of 5 · See all- K170163Erisma® LP Spinal Fixation SystemClariance, Sas · 2017 · cites it directly2descendants
- K162367Erisma® LP MISClariance, Sas · 2016 · cites it directly2descendants
- K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance · 2024 · 2 generations on1descendant
- K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance · 2024 · 2 generations on0descendants
- K191810Curiteva Pedicle Screw SystemCuriteva, Inc. · 2019 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K944736 | VSP (Variable Screw Placement) | Acromed Corp. | 1995 | — |
| −5 | K981274 | Acromed Timx Plate Based Low Back System | Acromed Corp. | 1998 | — |
| −4 | K010576 | Monarch Spine System | Depuyacromed | 2001 | — |
| −3 | K021148 | Monarch Spine System Commercially Pure Titanium Spinal Rod | Depuyacromed | 2002 | — |
| −2 | K052131 | Expedium Spine System 5.5MM Commerically Pure Titanium Spinal Rods | Depuy Spine, Inc. | 2005 | — |
| −1 | K120469 | Erisma-LP | Clariance | 2012 | — |
| 0 (this device) | K153326 | Erisma-LP Spinal Fixation System | Clariance, Sas | 2016 | — |
| +1 | K170163 | Erisma® LP Spinal Fixation System | Clariance, Sas | 2017 | — |
| +1 | K162367 | Erisma® LP MIS | Clariance, Sas | 2016 | — |
| +2 | K240872 | Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation System | Clariance | 2024 | — |
| +2 | K241863 | Erisma® Lp Spinal Fixation System; Erisma® LP MIS | Clariance | 2024 | — |
| +2 | K191810 | Curiteva Pedicle Screw System | Curiteva, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2024 | 2 | 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? (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 |
|---|---|---|---|
| * | K120469 | Erisma-LPSummary page 4…e Class III, 21 CFR 888.3070, NKB Class II, 21 CFR 888.3070, MNH and MNI Predicate and Reference Devices Erisma LP manufactured by CLARIANCE SAS (K120469) (Primary Predicate) Xia Spine System manufactured by Howmedica Osteonics Corp (now Stryker) (K001272) (Reference D… | 2012 |
| † | K001272 | Xia Spine System | 2000 |
| † | K142381 | Xia 3 Spinal System | 2014 |
| † | K143569 | CD HORIZON Spinal System | 2015 |
What descends from it? (5)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 1, 2019 | Class III | Z-1986-2019 | Use error | Potential for the polyaxial screw to become disassembled during implant. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 5 companies; a new generation was cleared every 3.4 years on median.
- None of the 18 ancestors has a recall.
- Of its descendants, K170163 (Clariance, Sas, 2017) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K120469.
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?
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 (discogenic pain 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K153326 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153326: Erisma-LP Spinal Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153326
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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