510(k) · Cleared
ClearedModification to Universal Multiaxis (Unimax) Pedicle Screw System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pisharodi Surgicals, Inc. · MNI Orthosis, Spinal Pedicle Fixation
Cleared on Aug 29, 2003 as substantially equivalent to K014302 (Pisharodi Surgicals, Inc., 2002) after a 248-day review. Its family tree reaches back 2 generations to 2000.
- Decided
- Aug 29, 2003
- Review
- 248 days
- Class
- Class II
- Product code
- MNI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K001532 (2000). No later device cites it as a predicate yet.
- Root · 2 generations backK001532 Dyna-Lok Classic Spinal SystemMedtronic Sofamor Danek, Inc. · 2000
- 1 generation backK014302 Universal Multiaxis (Unimax) Pedicle Screw SystemPisharodi Surgicals, Inc. · 2002
- This deviceK024313 Modification to Universal Multiaxis (Unimax) Pedicle Screw SystemPisharodi Surgicals, Inc. · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K001532 | Dyna-Lok Classic Spinal System | Medtronic Sofamor Danek, Inc. | 2000 | — |
| −1 | K014302 | Universal Multiaxis (Unimax) Pedicle Screw System | Pisharodi Surgicals, Inc. | 2002 | — |
| 0 (this device) | K024313 | Modification to Universal Multiaxis (Unimax) Pedicle Screw System | Pisharodi Surgicals, Inc. | 2003 | — |
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 |
|---|---|---|---|
| * | K014302 | Universal Multiaxis (Unimax) Pedicle Screw SystemSummary page 2…t of this Special 510(k) submission is the Offset Horizontal Plate. Its purpose is to provide rigidity to the spinal construct similar to the horizontal plate cleared on K014302. Summary Nonclinical Tests Analysis indicates that the offset horizontal plate is as strong as the predicate device.… | 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 3 years and passes through 2 companies; a new generation was cleared every 1.8 years on median.
- None of the 2 ancestors has a recall.
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?
The Pisharodi Surgicals, Inc. UNIMAX Pedicle Screw System is intended to provide, immobilization and stabilization of non-cervical posterior 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, When used as a pedicle screw fixation system of the non-cervical spine in skeletally mature patients, the UNIMAX Pedicle…
Read the full statement (183 words)
The Pisharodi Surgicals, Inc. UNIMAX Pedicle Screw System is intended to provide, immobilization and stabilization of non-cervical posterior 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,
When used as a pedicle screw fixation system of the non-cervical spine in skeletally mature patients, the UNIMAX Pedicle Screw System is indicated for one or more of the following: (1) degenerative spondylolisthesis with objective evidence of neurological impairment, (2) fracture, (3) dislocation, (4) scoliosis, (5) kyphosis, (6) spinal tumor, and/or (7) failed previous fusion (pseudarthrosis).
When used as a pedicle screw fixation system the UNIMAX Pedicle Screw System is indicated for skeletally mature patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (d) 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/K024313 · printed Nov 3, 2026
Cite this page
510(k) Report. “K024313: Modification to Universal Multiaxis (Unimax) Pedicle Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K024313
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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