510(k) · Cleared
ClearedSintea Biotech Posterior Lumbar System with Polyaxial and Recovery Screws, Model PLS.01.T5.X
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sintea Biotech, Inc. · KWP Appliance, Fixation, Spinal Interlaminal
Cleared on Dec 17, 2004 as substantially equivalent to K020085 (Sintea Biotech, Inc., 2002) and 1 other predicate after an 11-day review. Its family tree reaches back 2 generations to 2001. 2 later devices descend from it.
- Decided
- Dec 17, 2004
- Review
- 11 days
- Class
- Class II
- Product code
- KWP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K010515 (2001). 4 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK010515 Modification to Synergy Spinal SystemInterpore Cross Intl. · 2001
- 1 generation backK020085 Sintea Biotech Posterior Lumbar System, Model PLS 00.T5.XSintea Biotech, Inc. · 2002
- This deviceK043355 Sintea Biotech Posterior Lumbar System with Polyaxial and Recovery…Sintea Biotech, Inc. · 2004
- Descendant · cites it directly · 1 of its ownK081631 Sintea Biotech PLS Multi-Axial ScrewsSintea Biotech, Inc. · 2008
- Descendant · 2 generations on · 0 of its ownK112611 Sintea Plustek PLS Multi-Axial ScrewsSintea Plastek, LLC · 2012
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 |
|---|---|---|---|---|---|
| −2 | K010515 | Modification to Synergy Spinal System | Interpore Cross Intl. | 2001 | — |
| −1 | K020085 | Sintea Biotech Posterior Lumbar System, Model PLS 00.T5.X | Sintea Biotech, Inc. | 2002 | — |
| 0 (this device) | 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 | — |
| +2 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2012 | 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 KWP? 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 |
|---|---|---|---|
| * | K020085 | Sintea Biotech Posterior Lumbar System, Model PLS 00.T5.XSummary page 1…a special 5 10(k) submission, the predicate device to which we are claiming equivalence is our own product, Sintea Biotech's Posterior Lumbar System with standard screw (K020085, decision date 12/10/2002). This special 510(k) submission represents a modification to the predicate, in that the standard (mono… | 2002 |
| * | K031893 | Xia Spinal System and Xia Stainless Steel SystemSummary page 1…w and a recovery screw with ring. Additionally, we are claiming substantial equivalence to the Xia Spinal System's Polyaxial Screw, manufactured by Howmedica Osteonics, K03 1893, decision date 7/17/2003.… | 2003 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K081631 | Sintea Biotech PLS Multi-Axial Screws | 2008 | 1 |
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 2.0 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K081631 (Sintea Biotech, Inc., 2008) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K020085.
How does its category compare?
All KWP devicesKWP Appliance, Fixation, Spinal Interlaminal: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KWP
9in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · KWP
113in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWP
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWP
494in 2025
MAUDE reports naming product code KWP, 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 | 14 | 96 | 2 | 210 |
| 2008 | 13 | 50 | 1 | 594 |
| 2009 | 12 | 89 | 23 | 682 |
| 2010 | 14 | 186 | 2 | 474 |
| 2011 | 12 | 67 | 6 | 792 |
| 2012 | 18 | 112 | 1 | 918 |
| 2013 | 12 | 99 | 3 | 1,090 |
| 2014 | 13 | 138 | 0 | 1,022 |
| 2015 | 9 | 113 | 1 | 1,348 |
| 2016 | 0 | — | 3 | 1,379 |
| 2017 | 0 | — | 0 | 864 |
| 2018 | 0 | — | 1 | 657 |
| 2019 | 0 | — | 2 | 518 |
| 2020 | 0 | — | 0 | 796 |
| 2021 | 0 | — | 0 | 525 |
| 2022 | 0 | — | 2 | 335 |
| 2023 | 0 | — | 0 | 332 |
| 2024 | 0 | — | 0 | 436 |
| 2025 | 0 | — | 0 | 494 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Sintea Posterior Lumbar System 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 Sintea Biotech Posterior Lumbar System is a pedicle screw system intended to provide immobilization and…
Read the full statement (173 words)
The Sintea Posterior Lumbar System 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 Sintea Biotech 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 tumor, and failed previous fusion (pseudarthrosis).
The Sintea Biotech Posterior Lumbar System is a pedicle screw system indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-Sl 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/K043355 · printed Nov 4, 2026
Cite this page
510(k) Report. “K043355: Sintea Biotech Posterior Lumbar System with Polyaxial and Recovery Screws, Model PLS.01.T5.X.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K043355
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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