510(k) · Cleared
ClearedOsseus Black Diamond Pedicle Screw System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Osseus Fusion Systems, LLC · MNH Orthosis, Spondylolisthesis Spinal Fixation
Cleared on Aug 8, 2013 as substantially equivalent to K061520 (Depuy Spine, Inc., 2006) and 12 other predicates after a 50-day review. Its family tree reaches back 13 generations to 1985. 14 later devices descend from it.
- Decided
- Aug 8, 2013
- Review
- 50 days
- Class
- Class II
- Product code
- MNH
- Recalls
- None
- Predicates
- 13
Its longest line of descent runs back 13 generations to K853033 (1985). 140 ancestors in all, the oldest K841189 (1984). 14 later devices descend from it, 1 citing it directly.
- Root · 13 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 9 generations between
- 3 generations backK063741 Expedium Spine SystemDepuy Spine, Inc. · 2007
- 2 generations backK080313 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2008
- 1 generation backK111571 Viper SystemsJohnson & Johnson · 2011
- This deviceK131810 Osseus Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLC · 2013
- Descendant · cites it directly · 13 of its ownK192121 Black Diamond Pedicle Screw SystemOsseus Fusion Systems · 2019
- Descendant · 2 generations on · 12 of its ownK213935 PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems · 2022
- Descendant · 3 generations on · 5 of its ownK231199 Solar Lumbar Interbody Fusion SystemDegen Medical · 2023
- Descendant · 3 generations on · 4 of its ownK240326 Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc. · 2024
- Descendant · 3 generations on · 3 of its ownK223413 Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems · 2023
Show all 13 generations
- Root · 13 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 12 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
- 11 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
- 10 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
- 9 generations backK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
- 8 generations backK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
- 7 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
- 6 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
- 5 generations backK062174 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 4 generations backK063156 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 3 generations backK063741 Expedium Spine SystemDepuy Spine, Inc. · 2007
- 2 generations backK080313 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2008
- 1 generation backK111571 Viper SystemsJohnson & Johnson · 2011
- This deviceK131810 Osseus Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLC · 2013
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems · 2019 · cites it directly13descendants
- K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems · 2022 · 2 generations on12descendants
- K231199Solar Lumbar Interbody Fusion SystemDegen Medical · 2023 · 3 generations on5descendants
- K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc. · 2024 · 3 generations on4descendants
- K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems · 2023 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K853033 | Hartshill Rect & Wires, Spinal Fixation System | A.W. Showell (Surgicraft), Ltd. | 1985 | — |
| −12 | K965221 | Ransford Cervical Fixation System | Surgicraft, Ltd. | 1997 | — |
| −11 | K982322 | Synthes Spine Occipital-Cervical Plate/Rod and Hook System | Synthes (Usa) | 1998 | — |
| −10 | K002733 | Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2000 | — |
| −9 | K013222 | Summit Occipito-Cervico- Thoracic (Oct) Spinal System | Depuyacromed | 2001 | — |
| −8 | K022190 | Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2002 | — |
| −7 | K030103 | Summit Oct Spinal System Minipolyaxial Screws | Depuyacromed | 2003 | — |
| −6 | K041203 | Summit Oct Spinal System | Depuy Spine, Inc. | 2004 | — |
| −5 | K062174 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| −4 | K063156 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| −3 | K063741 | Expedium Spine System | Depuy Spine, Inc. | 2007 | — |
| −2 | K080313 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2008 | — |
| −1 | K111571 | Viper Systems | Johnson & Johnson | 2011 | — |
| 0 (this device) | K131810 | Osseus Black Diamond Pedicle Screw System | Osseus Fusion Systems, LLC | 2013 | — |
| +1 | K192121 | Black Diamond Pedicle Screw System | Osseus Fusion Systems | 2019 | — |
| +2 | K213935 | PISCES-SA Standalone ALIF Interbody System | Osseus Fusion Systems | 2022 | — |
| +3 | K231199 | Solar Lumbar Interbody Fusion System | Degen Medical | 2023 | — |
| +3 | K240326 | Solar™ Lumbar Interbody Fusion System | Degen Medical, Inc. | 2024 | — |
| +3 | K223413 | Pisces™-SA STANDALONE ALIF Interbody System | Osseus Fusion Systems | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1990 | 2 | 0 |
| 1992 | 5 | 0 |
| 1993 | 3 | 0 |
| 1994 | 1 | 0 |
| 1995 | 6 | 0 |
| 1996 | 4 | 0 |
| 1997 | 4 | 0 |
| 1998 | 9 | 0 |
| 1999 | 8 | 0 |
| 2000 | 11 | 0 |
| 2001 | 12 | 0 |
| 2002 | 7 | 0 |
| 2003 | 8 | 0 |
| 2004 | 14 | 0 |
| 2005 | 12 | 0 |
| 2006 | 5 | 0 |
| 2007 | 6 | 0 |
| 2008 | 5 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 4 | 0 |
| 2025 | 5 | 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 MNH? 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? (13)
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 |
|---|---|---|---|
| * | K061520 | Viper Spine SystemSummary page 1…CFR section: 21 CFR section 888.3070 Device panel: Orthopedic Legally Marketed Viper Spine System -DePuy Spine (1<061520 / K090648 / K102701 / 11157 1) Predicate Device: Low Torque Pedicle Screw -Altus Spine (Vertebron, Lid) K0333… | 2006 |
| * | K090648 | Viper 2 SystemSummary page 1…CFR section: 21 CFR section 888.3070 Device panel: Orthopedic Legally Marketed Viper Spine System -DePuy Spine (1<061520 / K090648 / K102701 / 11157 1) Predicate Device: Low Torque Pedicle Screw -Altus Spine (Vertebron, Lid) K033352/K043152… | 2009 |
| * | K102701 | Viper Spine SystemSummary page 1…on: 21 CFR section 888.3070 Device panel: Orthopedic Legally Marketed Viper Spine System -DePuy Spine (1<061520 / K090648 / K102701 / 11157 1) Predicate Device: Low Torque Pedicle Screw -Altus Spine (Vertebron, Lid) K033352/K0431521… | 2010 |
| * | K111571 | Viper Systems | 2011 |
| * | K033352 | Vertebron PSS Pedicle Screw SystemSummary page 1…ted Viper Spine System -DePuy Spine (1<061520 / K090648 / K102701 / 11157 1) Predicate Device: Low Torque Pedicle Screw -Altus Spine (Vertebron, Lid) K033352/K0431521 K051716/K071376 / K<081 597 Synergy VLS - op… | 2004 |
| * | K043152 | Vertebron PSS Pedicle Screw SystemSummary page 1…r Spine System -DePuy Spine (1<061520 / K090648 / K102701 / 11157 1) Predicate Device: Low Torque Pedicle Screw -Altus Spine (Vertebron, Lid) K033352/K0431521 K051716/K071376 / K<081 597 Synergy VLS - open (K940… | 2005 |
| * | K051716 | Vertebron PSS Pedicle Screw SystemSummary page 1…/ K102701 / 11157 1) Predicate Device: Low Torque Pedicle Screw -Altus Spine (Vertebron, Lid) K033352/K0431521 K051716/K071376 / K<081 597 Synergy VLS - open (K940631 / K<950099)… | 2005 |
| * | K071376 | Modification to Vertebron PSS Pedicle Screw SystemSummary page 1…01 / 11157 1) Predicate Device: Low Torque Pedicle Screw -Altus Spine (Vertebron, Lid) K033352/K0431521 K051716/K071376 / K<081 597 Synergy VLS - open (K940631 / K<950099) M… | 2007 |
| * | K081597 | Modification to Vertebron PSS Pedicle Screw System | 2008 |
| * | K940631 | Cross Medical - Synergy (TM) Spine SystemSummary page 1…Altus Spine (Vertebron, Lid) K033352/K0431521 K051716/K071376 / K<081 597 Synergy VLS - open (K940631 / K<950099) Moss Miami SS8- DePuy Spine (1<000536) PW… | 1995 |
| * | K950099 | Synergy (TM) TI Posterior Spinal SystemSummary page 1…(Vertebron, Lid) K033352/K0431521 K051716/K071376 / K<081 597 Synergy VLS - open (K940631 / K<950099) Moss Miami SS8- DePuy Spine (1<000536) PWvB (now Syn… | 1997 |
| * | K000536 | Synthes Anterior CSLP SystemSummary page 1…16/K071376 / K<081 597 Synergy VLS - open (K940631 / K<950099) Moss Miami SS8- DePuy Spine (1<000536) PWvB (now Synergy) (K<920116) Submitter: Osseus Fusion System… | 2000 |
| * | K920116 | PWB Lumbosacral Spine SystemSummary page 1…VLS - open (K940631 / K<950099) Moss Miami SS8- DePuy Spine (1<000536) PWvB (now Synergy) (K<920116) Submitter: Osseus Fusion Systems, LLC 4514 Cole Aye, Ste. 8… | 1992 |
What descends from it? (14)
See all 141 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K192121 | Black Diamond Pedicle Screw System | 2019 | 13 |
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 1.3 years on median.
- 9 of the 140 ancestors have a recall of any class.
- Of its descendants, K192121 (Osseus Fusion Systems, 2019) has gone furthest, with 13 descendants of its own.
- 16 other devices also cite its predicate K061520.
How does its category compare?
All MNH devicesMNH Orthosis, Spondylolisthesis Spinal Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · MNH
8in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · MNH
93in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MNH
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MNH
89in 2025
MAUDE reports naming product code MNH, 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 | 5 | 123 | 0 | 18 |
| 2008 | 13 | 65 | 0 | 30 |
| 2009 | 13 | 151 | 7 | 45 |
| 2010 | 10 | 106 | 0 | 59 |
| 2011 | 17 | 171 | 0 | 107 |
| 2012 | 7 | 93 | 1 | 433 |
| 2013 | 10 | 124 | 1 | 464 |
| 2014 | 12 | 140 | 0 | 286 |
| 2015 | 10 | 99 | 0 | 152 |
| 2016 | 8 | 93 | 1 | 216 |
| 2017 | 0 | — | 0 | 174 |
| 2018 | 0 | — | 0 | 129 |
| 2019 | 0 | — | 0 | 403 |
| 2020 | 0 | — | 0 | 432 |
| 2021 | 0 | — | 0 | 531 |
| 2022 | 0 | — | 0 | 265 |
| 2023 | 0 | — | 0 | 121 |
| 2024 | 0 | — | 0 | 302 |
| 2025 | 0 | — | 0 | 89 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Osseus Black Diamond Pedicle Screw 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 thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, deformities or curvatures (i.e. scoliosis, kyphosis…
Read the full statement (161 words)
The Osseus Black Diamond Pedicle Screw 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 thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), spinal tumor. pseudarthrosis and failed previous fusion.
The Osseus Black Diamond Pedicle Screw System is also intended for non-cervical pedicle screw fixation for the following indications: severe spondylolisthesis (grades 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. It is also intended for the following indications: trauma (i.e. fracture or dislocation); spinal stenosis; deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis; and failed previous fusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131810 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131810: Osseus Black Diamond Pedicle Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131810
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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