510(k) · Cleared
ClearedFaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous Fixation System, and AEON-C™ Stand Alone System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
K&J Consulting Corporation · MRW System, Facet Screw Spinal Device
Cleared on Dec 13, 2023 as substantially equivalent to K222515 (Dio Medical Corporation, 2022) and 3 other predicates after an 89-day review. Its family tree reaches back 23 generations to 1984. 1 of the 376 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.
- Decided
- Dec 13, 2023
- Review
- 89 days
- Class
- Class U
- Product code
- MRW
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 23 generations to K841189 (1984). 374 ancestors in all, the oldest K792352 (1979). 1 later device descends from it, 1 citing it directly. 1 of the 376 devices in this family, counting this one, has a Class I recall.
- Root · 23 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 19 generations between
- 3 generations backK181837 Spinal Elements Ti-Bond coated devicesSpinal Elements, Inc. · 2018
- 2 generations backK191477 AEON-C Stand Alone SystemHuvexel Co., Ltd. · 2019
- 1 generation backK223140 AEON-C™ Stand Alone SystemDio Medical, Inc. · 2022
- This deviceK232877 FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex…K&J Consulting Corporation · 2023
- Descendant · cites it directly · 0 of its ownK250335 IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting · 2025
Show all 23 generations
- Root · 23 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 22 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 21 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 20 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 19 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 18 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 17 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 16 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 15 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 14 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 13 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 12 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 11 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 10 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 9 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 8 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 7 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 6 generations backK151773 CONCORDE Bullet Lumbar Interbody SystemMedos International SARL · 2015
- 5 generations backK162327 COUGAR® LS Lateral Cage System and COUGAR® SystemMedos International SARL · 2016
- 4 generations backK170235 Lucent®Spinal Elements, Inc. · 2017
- 3 generations backK181837 Spinal Elements Ti-Bond coated devicesSpinal Elements, Inc. · 2018
- 2 generations backK191477 AEON-C Stand Alone SystemHuvexel Co., Ltd. · 2019
- 1 generation backK223140 AEON-C™ Stand Alone SystemDio Medical, Inc. · 2022
- This deviceK232877 FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex…K&J Consulting Corporation · 2023
Class I recalls in this family
- K073202 Ardis Spacer6 generations back · 2008
Most influential descendants
Showing 1 of 1 · See all- K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −23 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −22 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −21 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −20 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −19 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −18 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −17 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −16 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −15 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −14 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −13 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −12 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −11 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −10 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −9 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −8 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −7 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| −6 | K151773 | CONCORDE Bullet Lumbar Interbody System | Medos International SARL | 2015 | — |
| −5 | K162327 | COUGAR® LS Lateral Cage System and COUGAR® System | Medos International SARL | 2016 | — |
| −4 | K170235 | Lucent® | Spinal Elements, Inc. | 2017 | — |
| −3 | K181837 | Spinal Elements Ti-Bond coated devices | Spinal Elements, Inc. | 2018 | — |
| −2 | K191477 | AEON-C Stand Alone System | Huvexel Co., Ltd. | 2019 | — |
| −1 | K223140 | AEON-C™ Stand Alone System | Dio Medical, Inc. | 2022 | — |
| 0 (this device) | K232877 | FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex… | K&J Consulting Corporation | 2023 | — |
| +1 | K250335 | IVA & AEON Cervical and Lumbar Cage System | K&J Consulting | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 3 | 0 |
| 1999 | 6 | 0 |
| 2000 | 5 | 0 |
| 2001 | 14 | 0 |
| 2002 | 12 | 0 |
| 2003 | 17 | 0 |
| 2004 | 27 | 0 |
| 2005 | 22 | 0 |
| 2006 | 11 | 0 |
| 2007 | 17 | 0 |
| 2008 | 47 | 1 |
| 2009 | 29 | 0 |
| 2010 | 20 | 0 |
| 2011 | 30 | 0 |
| 2012 | 17 | 0 |
| 2013 | 20 | 0 |
| 2014 | 19 | 0 |
| 2015 | 10 | 0 |
| 2016 | 5 | 0 |
| 2017 | 4 | 0 |
| 2018 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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.
1 device in this family has a Class I recall. 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 MRW device
- #1 K230840 PMT Facet Fixation System, Lumbar (PMT FFS-LX)score 26.0 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (7)
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 |
|---|---|---|---|
| * | K222515 | FaSet Fixation SystemSummary page 10…ice is being used without the provided screws, supplemental fixation must be used. Predicate Primary Predicate: Device: FaSet Fixation System (K222515)- Huvexel Co. Ltd. Additional predicates: UNITY Sacroiliac Joint Fixation System (K222448) - Huvexe… | 2022 |
| * | K222448 | UNITY Sacroiliac Joint Fixation SystemSummary page 10…Predicate: Device: FaSet Fixation System (K222515)- Huvexel Co. Ltd. Additional predicates: UNITY Sacroiliac Joint Fixation System (K222448) - Huvexel Co. Ltd., Huvex Interspinous Fixation System (K223790) - Huvexel Co. Ltd., and AEON-C™ S… | 2022 |
| * | K223790 | Huvex Interspinous Fusion SystemSummary page 10…Additional predicates: UNITY Sacroiliac Joint Fixation System (K222448) - Huvexel Co. Ltd., Huvex Interspinous Fixation System (K223790) - Huvexel Co. Ltd., and AEON-C™ Stand Alone System (K223140) - Huvexel Co. Ltd. Substantial The K&J Consulting… | 2023 |
| * | K223140 | AEON-C™ Stand Alone SystemSummary page 10…ation System (K222448) - Huvexel Co. Ltd., Huvex Interspinous Fixation System (K223790) - Huvexel Co. Ltd., and AEON-C™ Stand Alone System (K223140) - Huvexel Co. Ltd. Substantial The K&J Consulting - FaSet Fixation System, Huvex Interspinous Equivalence: Fixation System,… | 2022 |
| * | — | Dio Medical - FaSet Fixation System Named without a submission number | |
| * | — | Dio Medical - Huvex Interspinous Fixation System Named without a submission number | |
| * | — | Dio Medical - AEON-C Stand Alone System Named without a submission number |
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 |
|---|---|---|---|
| K250335 | IVA & AEON Cervical and Lumbar Cage System | 2025 | 0 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K073202Ardis SpacerAbbott Spine, Inc. · 2008 · 6 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 39 years and passes through 16 companies; a new generation was cleared every 12 months on median.
- 43 of the 374 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K250335 (K&J Consulting, 2025) has gone furthest, with 0 descendants of its own.
How does its category compare?
All MRW devicesMRW System, Facet Screw Spinal Device: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · MRW
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MRW
97in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MRW
3in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MRW
3in 2025
MAUDE reports naming product code MRW, 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 | 0 | — | 0 | 1 |
| 2008 | 3 | 88 | 0 | 0 |
| 2009 | 6 | 89 | 0 | 2 |
| 2010 | 6 | 108 | 0 | 7 |
| 2011 | 3 | 122 | 3 | 62 |
| 2012 | 4 | 119 | 0 | 6 |
| 2013 | 7 | 110 | 0 | 4 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 2 | — | 0 | 2 |
| 2016 | 2 | — | 0 | 1 |
| 2017 | 1 | — | 0 | 4 |
| 2018 | 2 | — | 0 | 4 |
| 2019 | 3 | 90 | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 3 | 252 | 0 | 0 |
| 2023 | 3 | 190 | 0 | 1 |
| 2024 | 7 | 50 | 0 | 2 |
| 2025 | 7 | 97 | 0 | 3 |
| 2026 | 5 | 169 | 0 | — |
What is it indicated for?
The FaSet Fixation System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of facet joints. The Facet Screw System is indicated for posterior surgical treatment with or without bone graft at single or multiple levels from C2 to S1 (inclusive). For transfacet fixation, the screws are inserted posteriorly through the superior side of the facet, across the facet joint, and into the pedicle. For translaminar facet…
Read the full statement (466 words)
The FaSet Fixation System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of facet joints. The Facet Screw System is indicated for posterior surgical treatment with or without bone graft at single or multiple levels from C2 to S1 (inclusive). For transfacet fixation, the screws are inserted posteriorly through the superior side of the facet, across the facet joint, and into the pedicle. For translaminar facet fixation, the screws are inserted posteriorly through the lateral aspect of the spinous process, through the lamina, through the superior side of the facet, across the facet joint, and into the pedicle. The FaSet Fixation System is indicated for treatment for any or all of the following:
- Spondylolisthesis
- Pseudoarthrosis or failed previous fusions which are symptomatic, or which may cause secondary instability or deformity
- Spondylolysis
- Degenerative Disk Disease (DDD) as defined by back pain of discogenic origin with degeneration of disk confirmed by history and radiographic studies and/or degenerative disease of the facets with instability
- Trauma including spinal fractures and/or dislocations.
The UNITY Sacroiliac Joint Fixation System is indicated for sacroiliac joint fusion for:
- Sacroiliac joint dysfunction including degenerative sacroiliitis and sacroiliac joint disruptions
- Augmenting immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion
The UNITY Sacroiliac Joint Fixation System is also indicated for fracture fixation of acute, non-acute, and non-traumatic fractures involving the sacroiliac joint.
The Huvex Interspinous Fixation System is a posterior, non-pedicle supplemental fixation device intended for use in the lumbar spine (T1-S1) as an adjunct to fusion in skeletally mature patients. It is intended for plate fixation/attachment to the spinous processes for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), tumor, and/or lumbar spinal stenosis. The Huvex Interspinous Fixation System is intended for use, in conjunction with autogenous bone graft, and not intended for stand-alone use.
The AEON-C™ Stand Alone System is a stand-alone anterior cervical intervertebral fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one or two contiguous levels from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The AEON-C™ Stand Alone System should be packed with autograft and/or allograft comprised of cancellous, cortical and/or corticocancellous bone graft and implanted with an anterior approach. Patients should receive at least six (6) weeks of non-operative treatment prior to treatment with a cervical intervertebral fusion device. If the device is being used without the provided screws, supplemental fixation must be used.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K232877 · printed Nov 4, 2026
Cite this page
510(k) Report. “K232877: FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous Fixation System, and AEON-C™ Stand Alone System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K232877
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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