510(k) · Cleared
ClearedDiamondback Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Eminent Spine · MNI Orthosis, Spinal Pedicle Fixation
Cleared on Apr 22, 2010 as substantially equivalent to K031655 (Medtronic Sofamor Danek USA, Inc., 2003) and 5 other predicates after a 69-day review. Its family tree reaches back 4 generations to 1990. 29 later devices descend from it.
- Decided
- Apr 22, 2010
- Review
- 69 days
- Class
- Class II
- Product code
- MNI
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 4 generations to K901587 (1990). 25 ancestors in all. 29 later devices descend from it, 4 citing it directly.
- Root · 4 generations backK901587 TSRH Sacral L-ConnectorDanek Medical, Inc. · 1990
- 3 generations backK950099 Synergy (TM) TI Posterior Spinal SystemBuckman Co., Inc. · 1997
- 2 generations backK973836 Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the…Cross Medical Products, Inc. · 1998
- 1 generation backK974749 Synergy Closed Variable Locking Screw (VLS), Part of the Cross…Cross Medical Products, Inc. · 1998
- This deviceK100377 Diamondback Spinal SystemEminent Spine · 2010
- Descendant · cites it directly · 22 of its ownK102853 Flamenco Spinal Fixation SystemUlrich GmbH & Co. KG · 2011 · Recalled
- Descendant · 2 generations on · 18 of its ownK120891 Tangors Multifunctional Posterior SystemUlrich GmbH & Co. KG · 2012
- Descendant · 2 generations on · 17 of its ownK123717 UcentumUlrich GmbH & Co. KG · 2013 · Recalled
- Descendant · 3 generations on · 11 of its ownK151727 Everest Spinal SystemK2m, Inc. · 2015
- Descendant · 4 generations on · 9 of its ownK161369 EVEREST Spinal SystemK2m, Incorporated · 2016
Showing 5 of 29 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 29 · See all- K102853Flamenco Spinal Fixation SystemUlrich GmbH & Co. KG · 2011 · cites it directly22descendants
- K120891Tangors Multifunctional Posterior SystemUlrich GmbH & Co. KG · 2012 · 2 generations on18descendants
- K123717UcentumUlrich GmbH & Co. KG · 2013 · 2 generations on17descendants
- K151727Everest Spinal SystemK2m, Inc. · 2015 · 3 generations on11descendants
- K161369EVEREST Spinal SystemK2m, Incorporated · 2016 · 4 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K901587 | TSRH Sacral L-Connector | Danek Medical, Inc. | 1990 | — |
| −3 | K950099 | Synergy (TM) TI Posterior Spinal System | Buckman Co., Inc. | 1997 | — |
| −2 | K973836 | Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the Cross… | Cross Medical Products, Inc. | 1998 | — |
| −1 | K974749 | Synergy Closed Variable Locking Screw (VLS), Part of the Cross Medical-Synergy… | Cross Medical Products, Inc. | 1998 | — |
| 0 (this device) | K100377 | Diamondback Spinal System | Eminent Spine | 2010 | — |
| +1 | K102853 | Flamenco Spinal Fixation System | Ulrich GmbH & Co. KG | 2011 | 1 |
| +2 | K120891 | Tangors Multifunctional Posterior System | Ulrich GmbH & Co. KG | 2012 | — |
| +2 | K123717 | Ucentum | Ulrich GmbH & Co. KG | 2013 | 1 |
| +3 | K151727 | Everest Spinal System | K2m, Inc. | 2015 | — |
| +4 | K161369 | EVEREST Spinal System | K2m, Incorporated | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1992 | 5 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 4 | 0 |
| 2012 | 1 | 0 |
| 2013 | 3 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 5 | 0 |
| 2025 | 3 | 0 |
| 2026 | 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 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? (6)
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 |
|---|---|---|---|
| * | K031655 | CD Horizon Spinal SystemSummary page 1…dback~m Spinal System components are manufactured from titanium alloy (Ti-6A1-4V) as described by ASTM F136. Predicate Devices: CD HORIZON® (K031655/K041460) Moss Miami (K992168/K022623) Synergy VLS (K950099/K974749 === Page 2 ==… | 2003 |
| * | K041460 | CD Horizon Spinal SystemSummary page 1…Spinal System components are manufactured from titanium alloy (Ti-6A1-4V) as described by ASTM F136. Predicate Devices: CD HORIZON® (K031655/K041460) Moss Miami (K992168/K022623) Synergy VLS (K950099/K974749… | 2004 |
| * | K992168 | Moss Miami 6.35MM Polyaxial ScrewSummary page 1…from titanium alloy (Ti-6A1-4V) as described by ASTM F136. Predicate Devices: CD HORIZON® (K031655/K041460) Moss Miami (K992168/K022623) Synergy VLS (K950099/K974749… | 1999 |
| * | K022623 | 5.0 MM Diameter Polyaxial Screws (Moss Miami 6.35MM System)Summary page 1…from titanium alloy (Ti-6A1-4V) as described by ASTM F136. Predicate Devices: CD HORIZON® (K031655/K041460) Moss Miami (K992168/K022623) Synergy VLS (K950099/K974749… | 2002 |
| * | K950099 | Synergy (TM) TI Posterior Spinal SystemSummary page 1…s described by ASTM F136. Predicate Devices: CD HORIZON® (K031655/K041460) Moss Miami (K992168/K022623) Synergy VLS (K950099/K974749 f~a2-oF Z Technolo… | 1997 |
| * | K974749 | Synergy Closed Variable Locking Screw (VLS), Part of the Cross Medical-Synergy Anterior…Summary page 1…bed by ASTM F136. Predicate Devices: CD HORIZON® (K031655/K041460) Moss Miami (K992168/K022623) Synergy VLS (K950099/K974749 f~a2-oF Z Technological… | 1998 |
What descends from it? (29)
See all 294 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 20 years and passes through 4 companies; a new generation was cleared every 6.2 years on median.
- 1 of the 25 ancestors has a recall of any class.
- Of its descendants, K102853 (Ulrich GmbH & Co. KG, 2011) has gone furthest, with 22 descendants of its own.
- 24 other devices also cite its predicate K031655.
How does its category compare?
All MNI devicesMNI Orthosis, Spinal Pedicle Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 Diamondback' TM Spinal System is designed to provide immobilization and stabilization of thoracic, lumbar, and sacral spinal segments as an adjunct to fusion in skeletally mature patients. The system is intended for posterior, pedicle fixation for the treatment of severe spondylolisthesis (grades 3 and 4) of the L5-Sl vertebra. In addition, when used as a pedicle screw fixation system of the non-cervical posterior spine (Ti to S2) the system is…
Read the full statement (106 words)
The Diamondback' TM Spinal System is designed to provide immobilization and stabilization of thoracic, lumbar, and sacral spinal segments as an adjunct to fusion in skeletally mature patients. The system is intended for posterior, pedicle fixation for the treatment of severe spondylolisthesis (grades 3 and 4) of the L5-Sl vertebra. In addition, when used as a pedicle screw fixation system of the non-cervical posterior spine (Ti to S2) the system is intended for the treatment of the following acute and chronic instabilities or deformities: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, spinal stenosis, scoliosis, kyphosis, lordlosis, spinal tumor, pseudlarthrosis and failed previous fusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100377 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100377: Diamondback Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100377
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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