510(k) · Cleared
Recalled · 2008Modification to Incompass Spinal Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spinal Concepts, Inc. · MNI Orthosis, Spinal Pedicle Fixation
Cleared on Nov 25, 2002 as substantially equivalent to K021564 (Spinal Concepts, Inc., 2002) after a 26-day review. Its family tree reaches back 1 generation to 2002. 122 later devices descend from it. It has been recalled once.
- Decided
- Nov 25, 2002
- Review
- 26 days
- Class
- Class II
- Product code
- MNI
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K021564 (2002). 122 later devices descend from it, 5 citing it directly.
- Root · 1 generation backK021564 Incompass Spinal Fixation SystemSpinal Concepts, Inc. · 2002 · Recalled
- This deviceK023644 Modification to Incompass Spinal Fixation SystemSpinal Concepts, Inc. · 2002
- Descendant · cites it directly · 109 of its ownK030625 Spinal Concepts Inc. PathfinderSpinal Concepts, Inc. · 2003 · Recalled
- Descendant · 2 generations on · 94 of its ownK071174 Pathfinder System Polyaxial Pedicle ScrewsAbbott Spine, Inc. · 2007 · Recalled
- Descendant · 2 generations on · 93 of its ownK113044 Synthes MirsSynthes Spine · 2011 · Recalled
- Descendant · 3 generations on · 74 of its ownK120571 Synthes Uss ConnectorSynthes Spine · 2012
- Descendant · 4 generations on · 67 of its ownK133746 Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC) · 2014 · Recalled
Showing 5 of 122 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 122 · See all- K030625Spinal Concepts Inc. PathfinderSpinal Concepts, Inc. · 2003 · cites it directly109descendants
- K071174Pathfinder System Polyaxial Pedicle ScrewsAbbott Spine, Inc. · 2007 · 2 generations on94descendants
- K113044Synthes MirsSynthes Spine · 2011 · 2 generations on93descendants
- K120571Synthes Uss ConnectorSynthes Spine · 2012 · 3 generations on74descendants
- K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC) · 2014 · 4 generations on67descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K021564 | Incompass Spinal Fixation System | Spinal Concepts, Inc. | 2002 | 1 |
| 0 (this device) | K023644 | Modification to Incompass Spinal Fixation System | Spinal Concepts, Inc. | 2002 | — |
| +1 | K030625 | Spinal Concepts Inc. Pathfinder | Spinal Concepts, Inc. | 2003 | 6 |
| +2 | K071174 | Pathfinder System Polyaxial Pedicle Screws | Abbott Spine, Inc. | 2007 | 4 |
| +2 | K113044 | Synthes Mirs | Synthes Spine | 2011 | 3 |
| +3 | K120571 | Synthes Uss Connector | Synthes Spine | 2012 | — |
| +4 | K133746 | Polaris Spinal System | Biomet Spine (Aka Ebi, LLC) | 2014 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2007 | 3 | 0 |
| 2008 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 7 | 0 |
| 2013 | 2 | 0 |
| 2014 | 4 | 0 |
| 2015 | 7 | 0 |
| 2016 | 3 | 0 |
| 2017 | 13 | 0 |
| 2018 | 4 | 0 |
| 2019 | 5 | 0 |
| 2020 | 7 | 0 |
| 2021 | 8 | 0 |
| 2022 | 7 | 0 |
| 2023 | 10 | 0 |
| 2024 | 13 | 0 |
| 2025 | 11 | 0 |
| 2026 | 10 | 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? (1)
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 |
|---|---|---|---|
| * | K021564 | Incompass Spinal Fixation System | 2002 |
What descends from it? (122)
See all 1225 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K030625 | Spinal Concepts Inc. Pathfinder | 2003 | 109 |
| K131980 | Sequoia Pedicle Screw System Including Speedlink II Transverse Connector System | 2013 | 10 |
| K180754 | C-Zero Pedicle Screw System, Freedom Pedicle Screw System | 2018 | 0 |
| K072672 | Sequoia Spinal System, Model 3300 Series | 2007 | 0 |
| K030087 | Spinal Concepts, Inc. Bacfix TI Spinal System | 2003 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 24, 2008 | Not classified | Z-1592-2008 | Error in labeling | Reports received regarding disassembly of T-Handle Driver components during surgery dropping the closure top into the surgical site. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All MNI devicesMNI Orthosis, Spinal Pedicle Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
When intended for pedicle screw fixation from TI-SI, the Incompass Spinal Fixation 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 disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and…
Read the full statement (362 words)
When intended for pedicle screw fixation from TI-SI, the Incompass Spinal Fixation 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 disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, deformities or curvatures (i.e. scoliosis, kyphosis, andor lordosis), tumor and failed previous fusion.
As a pedicle screw system placed between L3 and SI, the indications include Grade 3 or Grade 4 spondylolisthesis, when utilizing autologous bone graft, when affixed to the posterior lumbosacral spine, and intended to be removed after solid fusion is established.
When intended for non-pedicle, posterior screw fixation of the non-cervical spine (TI-Sl), the indications are idiopathic scoliosis, neuromuscular scoliosis/kyphoscoliosis with associated paralysis or spasticity, scoliosis with deficient posterior elements such as that resulting from laminectomy or myelomeningocele, spinal Fractures (acute reduction or late deformity), degenerative disc disease (back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), tumor, spondylolisthesis, spinal stenosis and failed previous fusion.
When intended for anterolateral screw, rod and or cable fixation of the T6-L5 spine the indications are degenerative disc disease (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, deformities or curvatures (i.e. scoliosis, kyphosis, andor lordosis), tumor and failed previous fusion.
The use of posterior spinal instrumentation in children has been reported in the literature. The Incompass Spinal Fixation System may be used for non-pedicle posterior use in this patient group.
After solid fusion occurs, these devices serve no functional purpose and should be removed. In most cases, removal is indicated because the implants are not intended to transfer or support forces developed during normal activities. Any decision to remove the device must be made by the physician and the patient, taking into consideration the patient’s general medical condition and the potential risk to the patient of a second surgical procedure.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023644 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023644: Modification to Incompass Spinal Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023644
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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