510(k) · Cleared
ClearedSintea Plustek PLS Multi-Axial Screws
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sintea Plastek, LLC · MNI Orthosis, Spinal Pedicle Fixation
Cleared on Apr 25, 2012 as substantially equivalent to K081631 (Sintea Biotech, Inc., 2008) after a 231-day review. Its family tree reaches back 4 generations to 2001.
- Decided
- Apr 25, 2012
- Review
- 231 days
- Class
- Class II
- Product code
- MNI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K010515 (2001). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK010515 Modification to Synergy Spinal SystemInterpore Cross Intl. · 2001
- 3 generations backK020085 Sintea Biotech Posterior Lumbar System, Model PLS 00.T5.XSintea Biotech, Inc. · 2002
- 2 generations backK043355 Sintea Biotech Posterior Lumbar System with Polyaxial and Recovery…Sintea Biotech, Inc. · 2004
- 1 generation backK081631 Sintea Biotech PLS Multi-Axial ScrewsSintea Biotech, Inc. · 2008
- This deviceK112611 Sintea Plustek PLS Multi-Axial ScrewsSintea Plastek, LLC · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K010515 | Modification to Synergy Spinal System | Interpore Cross Intl. | 2001 | — |
| −3 | K020085 | Sintea Biotech Posterior Lumbar System, Model PLS 00.T5.X | Sintea Biotech, Inc. | 2002 | — |
| −2 | K043355 | Sintea Biotech Posterior Lumbar System with Polyaxial and Recovery Screws… | Sintea Biotech, Inc. | 2004 | — |
| −1 | K081631 | Sintea Biotech PLS Multi-Axial Screws | Sintea Biotech, Inc. | 2008 | — |
| 0 (this device) | K112611 | Sintea Plustek PLS Multi-Axial Screws | Sintea Plastek, LLC | 2012 | — |
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 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 |
|---|---|---|---|
| * | K081631 | Sintea Biotech PLS Multi-Axial ScrewsSummary page 1…al 5 10(k) submission, the predicate device to which we are claiming equivalence is our own product, Sintea Biotech's Posterior Lumbar System Multi-axial Screws - DESCO (K081631). This 510(k) submission represents a modification to the predicate, in which the cross-links and connectors are added to the alr… | 2008 |
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 11 years and passes through 3 companies; a new generation was cleared every 3.6 years on median.
- None of the 6 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. 2012, 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 Posterior Lumber System Multi-Axial Screw DESCO is a posterior, nonpedicle screw system of the noncervical spine indicated for degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, tumor, pseudoarthrosis, and failed previous fusion. The Posterior Lumbar System is a pedicle screw system intended to provide immobilization and…
Read the full statement (171 words)
The Posterior Lumber System Multi-Axial Screw DESCO is a posterior, nonpedicle screw system of the noncervical spine indicated for degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, tumor, pseudoarthrosis, and failed previous fusion.
The Posterior Lumbar System is a pedicle screw system 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 tumfor, and failed previous fusion (pseudarthrosis).
The Posterior Lumbar System is a pedicle screw system indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1I 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112611 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112611: Sintea Plustek PLS Multi-Axial Screws.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112611
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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