510(k) · Cleared
ClearedRIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation Instruments
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ht Medical D.B.A. Xenix Medical · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Jun 12, 2025 as substantially equivalent to K243916 (Spinal Elements, Inc., 2025) and 3 other predicates after a 59-day review. Its family tree reaches back 20 generations to 2004. 1 later device descends from it.
- Decided
- Jun 12, 2025
- Review
- 59 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 20 generations to K040583 (2004). 375 ancestors in all, the oldest K781443 (1978). 1 later device descends from it, 1 citing it directly.
- Root · 20 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 16 generations between
- 3 generations backK180179 Firebird® Spinal Fixation Systems: Firebird System; Firebird…Orthofix, Inc. · 2018
- 2 generations backK222516 Mercury® II Spinal SystemSpinal Elements, Inc. · 2022
- 1 generation backK243916 Primus Spinal Fixation SystemSpinal Elements, Inc. · 2025
- This deviceK251154 RIVA Posterior Fixation System; RIVA Posterior Fixation System…Ht Medical D.B.A. Xenix Medical · 2025
- Descendant · cites it directly · 0 of its ownK262193 RIVA® Posterior Fixation System with NanoACTIV Surface Technology…Xenix Medical · 2026
Show all 20 generations
- Root · 20 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 19 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 18 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
- 17 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 16 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
- 15 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 14 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
- 13 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
- 12 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
- 11 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
- 10 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
- 9 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
- 8 generations backK121630 Range Spinal SystemK2m, Inc. · 2012
- 7 generations backK130932 Firebird Spinal Fixation SystemOrthofix, Inc. · 2013 · Recalled
- 6 generations backK151488 Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation SystemOrthofix, Inc. · 2015 · Recalled
- 5 generations backK153428 Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation SystemOrthofix, Inc. · 2016 · Recalled
- 4 generations backK171082 Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System…Orthofix, Inc. · 2017 · Recalled
- 3 generations backK180179 Firebird® Spinal Fixation Systems: Firebird System; Firebird…Orthofix, Inc. · 2018
- 2 generations backK222516 Mercury® II Spinal SystemSpinal Elements, Inc. · 2022
- 1 generation backK243916 Primus Spinal Fixation SystemSpinal Elements, Inc. · 2025
- This deviceK251154 RIVA Posterior Fixation System; RIVA Posterior Fixation System…Ht Medical D.B.A. Xenix Medical · 2025
Most influential descendants
Showing 1 of 1 · See all- K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −20 | K040583 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −19 | K041118 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −18 | K042025 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2004 | 4 |
| −17 | K043151 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −16 | K050809 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2005 | — |
| −15 | K052187 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −14 | K053101 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −13 | K091442 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2009 | — |
| −12 | K091974 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2009 | 1 |
| −11 | K102555 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2010 | — |
| −10 | K112473 | CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2011 | — |
| −9 | K113174 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2011 | 1 |
| −8 | K121630 | Range Spinal System | K2m, Inc. | 2012 | — |
| −7 | K130932 | Firebird Spinal Fixation System | Orthofix, Inc. | 2013 | 1 |
| −6 | K151488 | Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System | Orthofix, Inc. | 2015 | 1 |
| −5 | K153428 | Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System | Orthofix, Inc. | 2016 | 1 |
| −4 | K171082 | Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS… | Orthofix, Inc. | 2017 | 1 |
| −3 | K180179 | Firebird® Spinal Fixation Systems: Firebird System; Firebird Deformity System… | Orthofix, Inc. | 2018 | — |
| −2 | K222516 | Mercury® II Spinal System | Spinal Elements, Inc. | 2022 | — |
| −1 | K243916 | Primus Spinal Fixation System | Spinal Elements, Inc. | 2025 | — |
| 0 (this device) | K251154 | RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation… | Ht Medical D.B.A. Xenix Medical | 2025 | — |
| +1 | K262193 | RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA®… | Xenix Medical | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1984 | 2 | 0 |
| 1985 | 1 | 0 |
| 1986 | 2 | 0 |
| 1987 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 1 | 0 |
| 1990 | 3 | 0 |
| 1992 | 7 | 0 |
| 1993 | 2 | 0 |
| 1994 | 8 | 0 |
| 1995 | 15 | 0 |
| 1996 | 10 | 0 |
| 1997 | 11 | 0 |
| 1998 | 21 | 0 |
| 1999 | 8 | 0 |
| 2000 | 23 | 0 |
| 2001 | 25 | 0 |
| 2002 | 24 | 0 |
| 2003 | 22 | 0 |
| 2004 | 30 | 0 |
| 2005 | 26 | 0 |
| 2006 | 20 | 0 |
| 2007 | 9 | 0 |
| 2008 | 18 | 0 |
| 2009 | 9 | 0 |
| 2010 | 8 | 0 |
| 2011 | 10 | 0 |
| 2012 | 7 | 0 |
| 2013 | 3 | 0 |
| 2014 | 7 | 0 |
| 2015 | 5 | 0 |
| 2016 | 6 | 0 |
| 2018 | 3 | 0 |
| 2019 | 3 | 0 |
| 2021 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 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? (4)
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 |
|---|---|---|---|
| * | K243916 | Primus Spinal Fixation SystemSummary page 6…(s) Manufacture K-Number Primary Predicate Primus Spinal Fixation System Spinal Elements K243916 Additional Predicate Devices Atlas Spine Pedicle Screw System Atlas Spine K112759 Mariner Pedic… | 2025 |
| * | K112759 | Apclo Pedicle Screw SystemsSummary page 6…n System Spinal Elements K243916 Additional Predicate Devices Atlas Spine Pedicle Screw System Atlas Spine K112759 Mariner Pedicle Screw System SeaSpine K212692 Medtronic CD Horizon… | 2011 |
| * | K212692 | Mariner Pedicle Screw SystemSummary page 6…Devices Atlas Spine Pedicle Screw System Atlas Spine K112759 Mariner Pedicle Screw System SeaSpine K212692 Medtronic CD Horizon Medtronic K140454… | 2021 |
| * | K140454 | Navigated CD Horizon Solera Screwdriver/TapsSummary page 6…K112759 Mariner Pedicle Screw System SeaSpine K212692 Medtronic CD Horizon Medtronic K140454 K251154 Page 2 of 3 Perf… | 2014 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K262193 | RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor… | 2026 | 0 |
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 21 years and passes through 7 companies; a new generation was cleared every 10 months on median.
- 57 of the 375 ancestors have a recall of any class.
- Of its descendants, K262193 (Xenix Medical, 2026) has gone furthest, with 0 descendants of its own.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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?
The Xenix Medical RIVA Posterior Fixation System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion as a pedicle screw fixation system or anterolateral fixation, in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and/or sacral spine: • Degenerative disc disease (defined as discogenic back pain with degeneration of the disc…
Read the full statement (208 words)
The Xenix Medical RIVA Posterior Fixation System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion as a pedicle screw fixation system or anterolateral fixation, in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and/or sacral spine:
• Degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies).
• Spondylolisthesis
• Trauma (i.e. fracture or dislocation).
• Spinal Stenosis
• Deformities or curvatures (i.e scoliosis, kyphosis, and/or lordosis)
• Tumor
• Pseudoarthrosis
• Failed previous fusion
Xenix Medical fenestrated screws are intended to be used with saline or radiopaque dye.
Xenix Medical RIVA Posterior Fixation System Navigation Instruments are intended to be used with the Xenix Medical RIVA Posterior Fixation System during surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medtronic® StealthStation™ S8 System, in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the vertebra, can be identified relative to a CT or MRI based model, fluoroscopy images, or digitized landmarks of the anatomy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251154 · printed Nov 6, 2026
Cite this page
510(k) Report. “K251154: RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation Instruments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K251154
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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