510(k) · Cleared
ClearedThe Karma® Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spinal Elements, Inc. · MRW System, Facet Screw Spinal Device
Cleared on May 21, 2025 as substantially equivalent to K240085 (Zygofix, Ltd., 2024) after a 268-day review. Its family tree reaches back 8 generations to 1997.
- Decided
- May 21, 2025
- Review
- 268 days
- Class
- Class U
- Product code
- MRW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K953076 (1997). 22 ancestors in all. No later device cites it as a predicate yet.
- Root · 8 generations backK953076 Townley Facet/Pedicular Screw Plating SystemSofamor Danek USA,Inc. · 1997
- 7 generations backK051856 TRANS1 Facet ScrewsTrans1 Incorporated · 2005
- 6 generations backK073515 TRANS1 Facet ScrewTrans1 Incorporated · 2008
- 5 generations backK092568 Spartan S3 Facet SystemAmendia, Inc. · 2009
- 4 generations backK120340 Venus Facet Screw SystemApollo Spine, Inc. · 2012
- 3 generations backK163374 ALLY™ Facet ScrewsProvidence Medical Technology, Inc. · 2017
- 2 generations backK230840 PMT Facet Fixation System, Lumbar (PMT FFS-LX)Providence Medical Technology, Inc. · 2023
- 1 generation backK240085 zLOCK Lumbar Facet Fixation SystemZygofix, Ltd. · 2024
- This deviceK242527 The Karma® Fixation SystemSpinal Elements, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K953076 | Townley Facet/Pedicular Screw Plating System | Sofamor Danek USA,Inc. | 1997 | — |
| −7 | K051856 | TRANS1 Facet Screws | Trans1 Incorporated | 2005 | — |
| −6 | K073515 | TRANS1 Facet Screw | Trans1 Incorporated | 2008 | — |
| −5 | K092568 | Spartan S3 Facet System | Amendia, Inc. | 2009 | — |
| −4 | K120340 | Venus Facet Screw System | Apollo Spine, Inc. | 2012 | — |
| −3 | K163374 | ALLY™ Facet Screws | Providence Medical Technology, Inc. | 2017 | — |
| −2 | K230840 | PMT Facet Fixation System, Lumbar (PMT FFS-LX) | Providence Medical Technology, Inc. | 2023 | — |
| −1 | K240085 | zLOCK Lumbar Facet Fixation System | Zygofix, Ltd. | 2024 | — |
| 0 (this device) | K242527 | The Karma® Fixation System | Spinal Elements, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2008 | 2 | 0 |
| 2010 | 2 | 0 |
| 2013 | 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 MRW? 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 MRW device
- #1 K230840 PMT Facet Fixation System, Lumbar (PMT FFS-LX)score 26.0 · 6 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 |
|---|---|---|---|
| * | K240085 | zLOCK Lumbar Facet Fixation SystemSummary page 5…nclassified Proposed Regulatory Class unclassified Device Product Code MRW Primary Predicate Device zLOCK Lumbar Facet Fixation System (K240085) Reference Device Karma Fixation System (K180728 / K190289) III. DEVICE DESCRIPTION The Karma® Fixation System… | 2024 |
| † | K180728 | Spinal Elements Cerclage System | 2018 |
| † | K190289 | Karma® Fixation System | 2019 |
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 28 years and passes through 7 companies; a new generation was cleared every 2.9 years on median.
- 4 of the 22 ancestors have a recall of any class.
- 1 other device also cites its predicate K240085.
How does its category compare?
All MRW devicesMRW System, Facet Screw Spinal Device: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · MRW
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MRW
97in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MRW
3in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MRW
3in 2025
MAUDE reports naming product code MRW, 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 | 0 | — | 0 | 1 |
| 2008 | 3 | 88 | 0 | 0 |
| 2009 | 6 | 89 | 0 | 2 |
| 2010 | 6 | 108 | 0 | 7 |
| 2011 | 3 | 122 | 3 | 62 |
| 2012 | 4 | 119 | 0 | 6 |
| 2013 | 7 | 110 | 0 | 4 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 2 | — | 0 | 2 |
| 2016 | 2 | — | 0 | 1 |
| 2017 | 1 | — | 0 | 4 |
| 2018 | 2 | — | 0 | 4 |
| 2019 | 3 | 90 | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 3 | 252 | 0 | 0 |
| 2023 | 3 | 190 | 0 | 1 |
| 2024 | 7 | 50 | 0 | 2 |
| 2025 | 7 | 97 | 0 | 3 |
| 2026 | 5 | 169 | 0 | — |
What is it indicated for?
The Karma Fixation System is intended for bilateral facet stabilization for fusion as an adjunct to a 1-level interbody lumbar fusion from L1 to L5 with autogenous and/or allogenic bone graft. The Karma Fixation System must be accompanied by an FDA cleared intervertebral body fusion device implanted at the same spinal level. The Karma Fixation System is indicated for the treatment of patients with lumbar degenerative disc disease at a single level from L1 to L5 in skeletally mature patients who have failed conservative care.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K242527 · printed Nov 3, 2026
Cite this page
510(k) Report. “K242527: The Karma® Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K242527
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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