510(k) · Cleared
ClearedRIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor Sacroiliac Fixation System with NanoACTIV Surface Technology
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Xenix Medical · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Sep 14, 2026 as substantially equivalent to K251154 (Ht Medical D.B.A. Xenix Medical, 2025) and 2 other predicates after a 77-day review. Its family tree reaches back 23 generations to 1993.
- Decided
- Sep 14, 2026
- Review
- 77 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 23 generations to K930834 (1993). 464 ancestors in all, the oldest K781443 (1978). No later device cites it as a predicate yet.
- Root · 23 generations backK930834 AcutractAcu Med, Inc. · 1993
- 19 generations between
- 3 generations backK222605 iFuse TORQ® Implant SystemSI-BONE, Inc. · 2022
- 2 generations backK231829 Xenix Medical Sacroiliac Fixation SystemHt Medical D.B.A. Xenix Medical · 2023
- 1 generation backK233241 SOLACE Sacroiliac Fixation SystemHt Medical, LLC Dba Xenix Medical · 2023
- This deviceK262193 RIVA® Posterior Fixation System with NanoACTIV Surface Technology…Xenix Medical · 2026
Show all 23 generations
- Root · 23 generations backK930834 AcutractAcu Med, Inc. · 1993
- 22 generations backK051309 Roi Fusion Rods & PlatesReiley Orthopaedics, Inc. · 2005 · Recalled
- 21 generations backK080398 SI Joint Fusion SystemSI-BONE, Inc. · 2008
- 20 generations backK110838 Ifuse Implant SystemSI-BONE, Inc. · 2011
- 19 generations backK122074 Ifuse Implant SystemSI-BONE, Inc. · 2012
- 18 generations backK123850 Ifuse Implant SystemSI-BONE, Inc. · 2013
- 17 generations backK131405 Ifuse Implant SystemSI-BONE, Inc. · 2013
- 16 generations backK141049 Ifuse Implant SystemSI-BONE, Inc. · 2014
- 15 generations backK150714 SI-BONE iFuse Implant SystemSI-BONE, Inc. · 2015
- 14 generations backK151718 iFuse Implant SystemSI-BONE, Inc. · 2015
- 13 generations backK152681 iFuse Implant System (R)SI-BONE, Inc. · 2016
- 12 generations backK160652 iFUSE Implant SystemSI-BONE, Inc. · 2016
- 11 generations backK162733 iFuse Implant System® - iFuse-3D implantSI-BONE, Inc. · 2017
- 10 generations backK182983 iFuse Implant System®SI-BONE, Inc. · 2018
- 9 generations backK183342 SambaScrew 3D SI Fusion SystemOrthofix, Inc. · 2019
- 8 generations backK200696 FIREBIRD SI Fusion SystemOrthofix, Inc. · 2020 · Recalled
- 7 generations backK201664 FIREBIRD SI Fusion SystemOrthofix, Inc. · 2020
- 6 generations backK203138 FIREBIRD SI Fusion SystemOrthofix, Inc. · 2020
- 5 generations backK210667 FIREBIRD SI Fusion SystemOrthofix, Inc. · 2021
- 4 generations backK213667 iFuse-TORQ® Implant SystemSI-BONE, Inc. · 2022
- 3 generations backK222605 iFuse TORQ® Implant SystemSI-BONE, Inc. · 2022
- 2 generations backK231829 Xenix Medical Sacroiliac Fixation SystemHt Medical D.B.A. Xenix Medical · 2023
- 1 generation backK233241 SOLACE Sacroiliac Fixation SystemHt Medical, LLC Dba Xenix Medical · 2023
- This deviceK262193 RIVA® Posterior Fixation System with NanoACTIV Surface Technology…Xenix Medical · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −23 | K930834 | Acutract | Acu Med, Inc. | 1993 | — |
| −22 | K051309 | Roi Fusion Rods & Plates | Reiley Orthopaedics, Inc. | 2005 | 2 |
| −21 | K080398 | SI Joint Fusion System | SI-BONE, Inc. | 2008 | — |
| −20 | K110838 | Ifuse Implant System | SI-BONE, Inc. | 2011 | — |
| −19 | K122074 | Ifuse Implant System | SI-BONE, Inc. | 2012 | — |
| −18 | K123850 | Ifuse Implant System | SI-BONE, Inc. | 2013 | — |
| −17 | K131405 | Ifuse Implant System | SI-BONE, Inc. | 2013 | — |
| −16 | K141049 | Ifuse Implant System | SI-BONE, Inc. | 2014 | — |
| −15 | K150714 | SI-BONE iFuse Implant System | SI-BONE, Inc. | 2015 | — |
| −14 | K151718 | iFuse Implant System | SI-BONE, Inc. | 2015 | — |
| −13 | K152681 | iFuse Implant System (R) | SI-BONE, Inc. | 2016 | — |
| −12 | K160652 | iFUSE Implant System | SI-BONE, Inc. | 2016 | — |
| −11 | K162733 | iFuse Implant System® - iFuse-3D implant | SI-BONE, Inc. | 2017 | — |
| −10 | K182983 | iFuse Implant System® | SI-BONE, Inc. | 2018 | — |
| −9 | K183342 | SambaScrew 3D SI Fusion System | Orthofix, Inc. | 2019 | — |
| −8 | K200696 | FIREBIRD SI Fusion System | Orthofix, Inc. | 2020 | 1 |
| −7 | K201664 | FIREBIRD SI Fusion System | Orthofix, Inc. | 2020 | — |
| −6 | K203138 | FIREBIRD SI Fusion System | Orthofix, Inc. | 2020 | — |
| −5 | K210667 | FIREBIRD SI Fusion System | Orthofix, Inc. | 2021 | — |
| −4 | K213667 | iFuse-TORQ® Implant System | SI-BONE, Inc. | 2022 | — |
| −3 | K222605 | iFuse TORQ® Implant System | SI-BONE, Inc. | 2022 | — |
| −2 | K231829 | Xenix Medical Sacroiliac Fixation System | Ht Medical D.B.A. Xenix Medical | 2023 | — |
| −1 | K233241 | SOLACE Sacroiliac Fixation System | Ht Medical, LLC Dba Xenix Medical | 2023 | — |
| 0 (this device) | 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 | 4 | 0 |
| 1991 | 1 | 0 |
| 1992 | 7 | 0 |
| 1993 | 2 | 0 |
| 1994 | 8 | 0 |
| 1995 | 16 | 0 |
| 1996 | 13 | 0 |
| 1997 | 11 | 0 |
| 1998 | 21 | 0 |
| 1999 | 11 | 0 |
| 2000 | 24 | 0 |
| 2001 | 31 | 0 |
| 2002 | 29 | 0 |
| 2003 | 26 | 0 |
| 2004 | 39 | 0 |
| 2005 | 31 | 0 |
| 2006 | 21 | 0 |
| 2007 | 11 | 0 |
| 2008 | 20 | 0 |
| 2009 | 12 | 0 |
| 2010 | 12 | 0 |
| 2011 | 17 | 0 |
| 2012 | 10 | 0 |
| 2013 | 7 | 0 |
| 2014 | 7 | 0 |
| 2015 | 11 | 0 |
| 2016 | 8 | 0 |
| 2017 | 3 | 0 |
| 2018 | 4 | 0 |
| 2019 | 6 | 0 |
| 2020 | 1 | 0 |
| 2021 | 3 | 0 |
| 2022 | 2 | 0 |
| 2025 | 2 | 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? (3)
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 |
|---|---|---|---|
| * | K251154 | RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation InstrumentsSummary page 9…me(s) Manufacturer K-Number Primary Predicate RIVA Posterior Fixation System Xenix Medical K251154 Reference Predicate Devices neoWAVE LS Lumbar Straight, neoWAVE C Xenix Medical K222988 Cervical, and T… | 2025 |
| * | K220195 | iFuse Bedrock Granite™ Implant SystemSummary page 9…Cervical SOLACE Sacroiliac Fixation System Xenix Medical K233241 SI-Bone Bedrock Granite SI-Bone K220195 Performance Testing Summary: Engineering analysis and rationale was provided to demonstrate that the subject RIVA Fixation Syste… | 2022 |
| * | K233241 | SOLACE Sacroiliac Fixation SystemSummary page 9…Straight, neoWAVE C Xenix Medical K222988 Cervical, and Ti3D Cervical SOLACE Sacroiliac Fixation System Xenix Medical K233241 SI-Bone Bedrock Granite SI-Bone K220195 Performance Testing Summary: Engineering ana… | 2023 |
| † | K222988 | neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D Cervical | 2023 |
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 33 years and passes through 7 companies; a new generation was cleared every 9 months on median.
- 68 of the 464 ancestors have a recall of any class.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 (516 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 RIVA Posterior Fixation System 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.
The RIVA Anchor Sacroiliac Fixation System is intended for sacroiliac joint fusion for:
• Sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroiliitis. This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months.
• To augment immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion.
• Acute, non-acute, and non-traumatic fractures involving the sacroiliac joint.
When connected to the Xenix Medical RIVA Posterior Fixation System, the RIVA Anchor Sacroiliac 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 Anchor Sacroiliac 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/K262193 · printed Nov 6, 2026
Cite this page
510(k) Report. “K262193: RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor Sacroiliac Fixation System with NanoACTIV Surface Technology.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K262193
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026