510(k) · Cleared
ClearedDelta Spinal Fusion System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jemo Spine, LLC · MNI Orthosis, Spinal Pedicle Fixation
Cleared on Aug 8, 2007 as substantially equivalent to K020279 (Forex Corp., 2002) and 1 other predicate after a 34-day review. Its family tree reaches back 3 generations to 2000. 109 later devices descend from it.
- Decided
- Aug 8, 2007
- Review
- 34 days
- Class
- Class II
- Product code
- MNI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K000319 (2000). 5 ancestors in all. 109 later devices descend from it, 5 citing it directly.
- Root · 3 generations backK000319 Ebi Xfix DFS SystemEbi, L.P. · 2000
- 2 generations backK020279 Forex Corporation, Optima, Spinal SystemForex Corp. · 2002 · Recalled
- 1 generation backK024096 Optima, Spinal SystemU&I Corp., America · 2003 · Recalled
- This deviceK071857 Delta Spinal Fusion SystemJemo Spine, LLC · 2007
- Descendant · cites it directly · 100 of its ownK072022 Valeo Pedicle Screw Spinal SystemAmedica Corp. · 2007
- Descendant · 2 generations on · 43 of its ownK121115 M.U.S.T Pedicle Screw SystemMedacta International · 2012 · Recalled
- Descendant · 2 generations on · 30 of its ownK151977 icotec Pedicle SystemIcotec AG · 2016
- Descendant · 3 generations on · 29 of its ownK190545 VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG · 2019 · Recalled
- Descendant · 2 generations on · 28 of its ownK132878 M.U.S.T. ExtensionMedacta International · 2013
Showing 5 of 109 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 109 · See all- K072022Valeo Pedicle Screw Spinal SystemAmedica Corp. · 2007 · cites it directly100descendants
- K121115M.U.S.T Pedicle Screw SystemMedacta International · 2012 · 2 generations on43descendants
- K151977icotec Pedicle SystemIcotec AG · 2016 · 2 generations on30descendants
- K190545VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG · 2019 · 3 generations on29descendants
- K132878M.U.S.T. ExtensionMedacta International · 2013 · 2 generations on28descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K000319 | Ebi Xfix DFS System | Ebi, L.P. | 2000 | — |
| −2 | K020279 | Forex Corporation, Optima, Spinal System | Forex Corp. | 2002 | 4 |
| −1 | K024096 | Optima, Spinal System | U&I Corp., America | 2003 | 3 |
| 0 (this device) | K071857 | Delta Spinal Fusion System | Jemo Spine, LLC | 2007 | — |
| +1 | K072022 | Valeo Pedicle Screw Spinal System | Amedica Corp. | 2007 | — |
| +2 | K121115 | M.U.S.T Pedicle Screw System | Medacta International | 2012 | 1 |
| +2 | K151977 | icotec Pedicle System | Icotec AG | 2016 | — |
| +3 | K190545 | VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0 | Icotec AG | 2019 | 1 |
| +2 | K132878 | M.U.S.T. Extension | Medacta International | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 4 | 0 |
| 2013 | 4 | 0 |
| 2014 | 6 | 0 |
| 2015 | 3 | 0 |
| 2016 | 6 | 0 |
| 2017 | 4 | 0 |
| 2018 | 3 | 0 |
| 2019 | 4 | 0 |
| 2020 | 13 | 0 |
| 2021 | 7 | 0 |
| 2022 | 5 | 0 |
| 2023 | 12 | 0 |
| 2024 | 13 | 0 |
| 2025 | 7 | 0 |
| 2026 | 12 | 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 MNI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K020279 | Forex Corporation, Optima, Spinal SystemSummary page 1…§ 888.3070 - Spinal Intervertebral Body Fixation Orthosis (KWQ) 21 CFR § 888.3060 4. Predicate Device: U&I Corporation, OPTIMA Tm Spinal System -- MNH, MNI, KWQ -- (K020279 and K024096) 5. Device Description: The Jemo Spine, LLC, DELTATM, Spinal Fusion System is a top-lo… | 2002 |
| * | K024096 | Optima, Spinal SystemSummary page 1…ral Body Fixation Orthosis (KWQ) 21 CFR § 888.3060 4. Predicate Device: U&I Corporation, OPTIMA Tm Spinal System -- MNH, MNI, KWQ -- (K020279 and K024096) 5. Device Description: The Jemo Spine, LLC, DELTATM, Spinal Fusion System is a top-loading posterior spinal fixation sys… | 2003 |
What descends from it? (109)
See all 1095 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 7 years and passes through 4 companies; a new generation was cleared every 2.3 years on median.
- 2 of the 5 ancestors have a recall of any class.
- Of its descendants, K072022 (Amedica Corp., 2007) has gone furthest, with 100 descendants of its own.
- 8 other devices also cite its predicate K020279.
How does its category compare?
All MNI devicesMNI Orthosis, Spinal Pedicle Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · MNI
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · MNI
168in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MNI
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MNI
80in 2025
MAUDE reports naming product code MNI, 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 | 20 | 82 | 26 | 83 |
| 2008 | 23 | 64 | 8 | 108 |
| 2009 | 18 | 86 | 3 | 138 |
| 2010 | 16 | 74 | 1 | 126 |
| 2011 | 17 | 111 | 0 | 146 |
| 2012 | 19 | 75 | 1 | 200 |
| 2013 | 14 | 77 | 4 | 824 |
| 2014 | 6 | 104 | 0 | 301 |
| 2015 | 12 | 54 | 1 | 260 |
| 2016 | 7 | 168 | 0 | 117 |
| 2017 | 1 | — | 0 | 247 |
| 2018 | 0 | — | 1 | 134 |
| 2019 | 0 | — | 0 | 188 |
| 2020 | 0 | — | 0 | 115 |
| 2021 | 0 | — | 0 | 270 |
| 2022 | 0 | — | 0 | 214 |
| 2023 | 0 | — | 0 | 122 |
| 2024 | 0 | — | 0 | 114 |
| 2025 | 0 | — | 0 | 80 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Jemo Spine, LLC, DELTA TM, Spinal Fusion System, a posterior spinal fixation device is a pedicle screw system indicated for the treatment of severe Spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. In addition, the Jemo Spine, LLC…
Read the full statement (194 words)
The Jemo Spine, LLC, DELTA TM, Spinal Fusion System, a posterior spinal fixation device is a pedicle screw system indicated for the treatment of severe Spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.
In addition, the Jemo Spine, LLC, DELTA TM , Spinal Fusion System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: degenerative Spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudarthrosis).
When used as an posterior screw fixation system such as a sacral/iliac screw fixation system, the Jemo Spine, LLC, DELTATM , Spinal Fusion System is indicated for patients with severe Spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra, fracture, spinal stenosis, spinal deformities such as scoliosis, kyphosis, lordosis, tumor, pseudoarthrosis, or revision of failed fusion attempts.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071857 · printed Nov 5, 2026
Cite this page
510(k) Report. “K071857: Delta Spinal Fusion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K071857
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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