510(k) · Cleared
Recalled · Class II · 2018Spondylolisthesis Spinal Fixation, Spinal Pedicle Fixation
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Accel Spine · MNI Orthosis, Spinal Pedicle Fixation
Cleared on Aug 20, 2013 as substantially equivalent to K113324 (Dio Medical Co., Ltd., 2012) and 2 other predicates after a 21-day review. Its family tree reaches back 6 generations to 2000. 2 later devices descend from it. It has been recalled 2 times.
- Decided
- Aug 20, 2013
- Review
- 21 days
- Class
- Class II
- Product code
- MNI
- Recalls
- 2
- Predicates
- 3
Its longest line of descent runs back 6 generations to K000319 (2000). 20 ancestors in all, the oldest K884263 (1988). 2 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK000319 Ebi Xfix DFS SystemEbi, L.P. · 2000
- 5 generations backK020279 Forex Corporation, Optima, Spinal SystemForex Corp. · 2002 · Recalled
- 4 generations backK031585 U&I, Optima, Spinal SystemU&I Corp., America · 2003 · Recalled
- 3 generations backK053573 GSS Pedicle Screw SystemGS Medical Co., Ltd. · 2006
- 2 generations backK100765 Fixpine II SystemDio Medical Co., Ltd. · 2010
- 1 generation backK111362 Rexious Spinal Fixation SystemDio Medical Co., Ltd. · 2011
- This deviceK132365 Spondylolisthesis Spinal Fixation, Spinal Pedicle FixationAccel Spine · 2013
- Descendant · cites it directly · 1 of its ownK140219 Picasso II Mis Spinal SystemAccel Spine · 2014
- Descendant · cites it directly · 0 of its ownK173185 SEURAT™ Universal Pedicle Screw SystemCtl Medical Corporation · 2018
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K000319 | Ebi Xfix DFS System | Ebi, L.P. | 2000 | — |
| −5 | K020279 | Forex Corporation, Optima, Spinal System | Forex Corp. | 2002 | 4 |
| −4 | K031585 | U&I, Optima, Spinal System | U&I Corp., America | 2003 | 5 |
| −3 | K053573 | GSS Pedicle Screw System | GS Medical Co., Ltd. | 2006 | — |
| −2 | K100765 | Fixpine II System | Dio Medical Co., Ltd. | 2010 | — |
| −1 | K111362 | Rexious Spinal Fixation System | Dio Medical Co., Ltd. | 2011 | — |
| 0 (this device) | K132365 | Spondylolisthesis Spinal Fixation, Spinal Pedicle Fixation | Accel Spine | 2013 | — |
| +1 | K140219 | Picasso II Mis Spinal System | Accel Spine | 2014 | — |
| +1 | K173185 | SEURAT™ Universal Pedicle Screw System | Ctl Medical Corporation | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 4 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2018 | 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? (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 |
|---|---|---|---|
| * | K113324 | Rexious Hook Fixation SystemsSummary page 1…PROPRIETARY NAME Raphael Pedicle Screw System IDENTIFICATION OF PREDICATE DEVICE(S) Dio Medical Rexious Spinal Fixation System (K1 13324, K111362, 1100765)… | 2012 |
| * | K111362 | Rexious Spinal Fixation SystemSummary page 1…Pedicle Screw System IDENTIFICATION OF PREDICATE DEVICE(S) Dio Medical Rexious Spinal Fixation System (K1 13324, K111362, 1100765)… | 2011 |
| * | K100765 | Fixpine II SystemSummary page 1…rew System IDENTIFICATION OF PREDICATE DEVICE(S) Dio Medical Rexious Spinal Fixation System (K1 13324, K111362, 1100765) K… | 2010 |
What descends from it? (2)
2 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 5, 2018 | Class II | Z-1030-2019 | Nonconforming Material/Component | the anti-toggle ring of the hex driver may separate from the driver shaft. If this occurs during surgery, the anti-toggle ring can be pressed into the pedicle screw head and cause separation of the screw from the housing upon tightening.… |
| Jul 5, 2018 | Class II | Z-1031-2019 | Nonconforming Material/Component | the anti-toggle ring of the hex driver may separate from the driver shaft. If this occurs during surgery, the anti-toggle ring can be pressed into the pedicle screw head and cause separation of the screw from the housing upon tightening.… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 6 companies; a new generation was cleared every 2.3 years on median.
- 3 of the 20 ancestors have a recall of any class.
- Of its descendants, K140219 (Accel Spine, 2014) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K113324.
How does its category compare?
All MNI devicesMNI Orthosis, Spinal Pedicle Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 Raphael Pedicle Screw System is a posterior pedicle screw system indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S I 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. In addition, the Raphael Pedicle Screw System is intended to provide…
Read the full statement (196 words)
The Raphael Pedicle Screw System is a posterior pedicle screw system indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S I 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.
In addition, the Raphael 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 the thoracic lumbar and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudarth rosis).
The Raphael Hook System is intended for use as a posterior, noncervical, nonpedicle system indicated for 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); spinal stenosis; curvatures (i.e., scoliosis, kylphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. The Raphael Hook System can be used in conjunction with Raphael Pedicle Screw System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132365 · printed Nov 5, 2026
Cite this page
510(k) Report. “K132365: Spondylolisthesis Spinal Fixation, Spinal Pedicle Fixation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K132365
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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