510(k) · Cleared
ClearedProcyon Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nas Medical Technologies, Inc. · MNH Orthosis, Spondylolisthesis Spinal Fixation
Cleared on Jun 3, 2004 as substantially equivalent to K030285 (Medtronic Sofamor Danek, Inc., 2003) and 1 other predicate after a 210-day review. Its family tree reaches back 2 generations to 1999.
- Decided
- Jun 3, 2004
- Review
- 210 days
- Class
- Class II
- Product code
- MNH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K993030 (1999). 4 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K993030 | Modification to Isola Spinal System | Depuyacromed | 1999 | — |
| −1 | K021335 | Monarch Spine System | Depuyacromed | 2002 | — |
| 0 (this device) | K033512 | Procyon Spinal System | Nas Medical Technologies, Inc. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2003 | 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 MNH? 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? (2)
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 |
|---|---|---|---|
| * | K030285 | Modification to TSRH Spinal SystemSummary page 1…below); and 4) who are having the device removed after the development of a solid fusion mass. Predicate Devices: TSRH Spinal System (K030285) MONARCH Spine System (K02 1335) Performance Data: Performance data were submitted to charac… | 2003 |
| * | K021335 | Monarch Spine SystemSummary page 1…development of a solid fusion mass. Predicate Devices: TSRH Spinal System (K030285) MONARCH Spine System (K02 1335) Performance Data: Performance data were submitted to characterize the Procyon Spinal System… | 2002 |
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 5 years and passes through 2 companies; a new generation was cleared every 2.5 years on median.
- None of the 4 ancestors has a recall.
- 3 other devices also cite its predicate K030285.
How does its category compare?
All MNH devicesMNH Orthosis, Spondylolisthesis Spinal Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MNH
8in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · MNH
93in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MNH
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MNH
89in 2025
MAUDE reports naming product code MNH, 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 | 5 | 123 | 0 | 18 |
| 2008 | 13 | 65 | 0 | 30 |
| 2009 | 13 | 151 | 7 | 45 |
| 2010 | 10 | 106 | 0 | 59 |
| 2011 | 17 | 171 | 0 | 107 |
| 2012 | 7 | 93 | 1 | 433 |
| 2013 | 10 | 124 | 1 | 464 |
| 2014 | 12 | 140 | 0 | 286 |
| 2015 | 10 | 99 | 0 | 152 |
| 2016 | 8 | 93 | 1 | 216 |
| 2017 | 0 | — | 0 | 174 |
| 2018 | 0 | — | 0 | 129 |
| 2019 | 0 | — | 0 | 403 |
| 2020 | 0 | — | 0 | 432 |
| 2021 | 0 | — | 0 | 531 |
| 2022 | 0 | — | 0 | 265 |
| 2023 | 0 | — | 0 | 121 |
| 2024 | 0 | — | 0 | 302 |
| 2025 | 0 | — | 0 | 89 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
When used as a pedicle screw fixation system in the non-cervical spine of skeletally mature patients, the Procyon Spinal System is intended for immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: 1) degenerative spondylolisthesis with objective evidence of neurological impairment, 2) fracture, 3) dislocation…
Read the full statement (155 words)
When used as a pedicle screw fixation system in the non-cervical spine of skeletally mature patients, the Procyon Spinal System is intended for immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: 1) degenerative spondylolisthesis with objective evidence of neurological impairment, 2) fracture, 3) dislocation, 4) scoliosis, 5) kypohsis, 6) spinal tumor and 7) failed previous fusion (pseudoarthrosis).
In addition, when used as a pedicle screw fixation system, the Procyon Spinal System is intended for skeletally mature patients: 1) having severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra, 2) who are receiving fusion by autogenous bone graft only; 3) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and 4) who are having the device removed after the development of a solid fusion mass.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033512 · printed Nov 3, 2026
Cite this page
510(k) Report. “K033512: Procyon Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K033512
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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