510(k) Report

510(k) · Cleared

Cleared

Sintea Biotech Posterior Lumbar System, Model PLS 00.T5.X

K020085510(k) TraditionalCleared Dec 10, 2002334-day reviewClass II21 CFR 888.3070

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Sintea Biotech, Inc. · MNH Orthosis, Spondylolisthesis Spinal Fixation

Cleared on Dec 10, 2002 as substantially equivalent to K010720 (Medtronic Sofamor Danek, Inc., 2001) and 1 other predicate after a 334-day review. Its family tree reaches back 1 generation to 2001. 3 later devices descend from it.

Decided
Dec 10, 2002
Review
334 days
Class
Class II
Product code
MNH
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K010515 (2001). 2 ancestors in all. 3 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2001: 1 other ancestor2004: 1 descendant cleared2008: 1 descendant cleared2012: 1 descendant clearedK010515 · Modification to Synergy Spinal System · Interpore Cross Intl. · 2001200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 2 descendants2 generations forward: 1 descendant K010515 · Modification to Synergy Spinal System · Interpore Cross Intl. · 20010
  1. Root · 1 generation backK010515 Modification to Synergy Spinal SystemInterpore Cross Intl. · 2001
  2. This deviceK020085 Sintea Biotech Posterior Lumbar System, Model PLS 00.T5.XSintea Biotech, Inc. · 2002
  3. Descendant · cites it directly · 2 of its ownK043355 Sintea Biotech Posterior Lumbar System with Polyaxial and Recovery…Sintea Biotech, Inc. · 2004
  4. Descendant · cites it directly · 1 of its ownK081631 Sintea Biotech PLS Multi-Axial ScrewsSintea Biotech, Inc. · 2008
  5. Descendant · 2 generations on · 0 of its ownK112611 Sintea Plustek PLS Multi-Axial ScrewsSintea Plastek, LLC · 2012

Most influential descendants

Showing 3 of 3 · See all
  • K043355Sintea Biotech Posterior Lumbar System with Polyaxial and Recovery Screws, Model…Sintea Biotech, Inc. · 2004 · cites it directly2descendants
  • K081631Sintea Biotech PLS Multi-Axial ScrewsSintea Biotech, Inc. · 2008 · cites it directly1descendant
  • K112611Sintea Plustek PLS Multi-Axial ScrewsSintea Plastek, LLC · 2012 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K010515Modification to Synergy Spinal SystemInterpore Cross Intl.2001—
0 (this device)K020085Sintea Biotech Posterior Lumbar System, Model PLS 00.T5.XSintea Biotech, Inc.2002—
+1K043355Sintea Biotech Posterior Lumbar System with Polyaxial and Recovery Screws…Sintea Biotech, Inc.2004—
+1K081631Sintea Biotech PLS Multi-Axial ScrewsSintea Biotech, Inc.2008—
+2K112611Sintea Plustek PLS Multi-Axial ScrewsSintea Plastek, LLC2012—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200810
201210
FIG. 1 — Lineage of K020085, 2001–2012Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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
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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.

TypeNumberDeviceApplicantDecidedRecalls
*K010720TSRH Spinal SystemMedtronic Sofamor Danek, Inc.2001—
*K010515Modification to Synergy Spinal SystemInterpore Cross Intl.2001—

Also cleared against K010720: 2 other devices →

What descends from it? (3)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K043355Sintea Biotech Posterior Lumbar System with Polyaxial and Recovery Screws, Model…Sintea Biotech, Inc.20042
K081631Sintea Biotech PLS Multi-Axial ScrewsSintea Biotech, Inc.20081

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?

  • None of the 2 ancestors has a recall.
  • Of its descendants, K043355 (Sintea Biotech, Inc., 2004) has gone furthest, with 2 descendants of its own.
  • 2 other devices also cite its predicate K010720.

How does its category compare?

All MNH devices

MNH Orthosis, Spondylolisthesis Spinal Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MNH

8in 2016

2007: 52008: 132009: 132010: 102011: 172012: 72013: 102014: 122015: 102016: 8
2007high 17 (2011) · low 0 (2017)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MNH

93in 2016

2007: 123 days median2008: 65 days median2009: 151 days median2010: 106 days median2011: 171 days median2012: 93 days median2013: 124 days median2014: 140 days median2015: 99 days median2016: 93 days median
2007high 171 (2011) · low 65 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MNH

1in 2016

2009: 72012: 12013: 12016: 1
2007high 7 (2009) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MNH

89in 2025

2007: 182008: 302009: 452010: 592011: 1072012: 4332013: 4642014: 2862015: 1522016: 2162017: 1742018: 1292019: 4032020: 4322021: 5312022: 2652023: 1212024: 3022025: 89
2007high 531 (2021) · low 18 (2007)2025

MAUDE reports naming product code MNH, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20075123018
20081365030
200913151745
201010106059
2011171710107
20127931433
2013101241464
2014121400286
201510990152
20168931216
20170—0174
20180—0129
20190—0403
20200—0432
20210—0531
20220—0265
20230—0121
20240—0302
20250—089
20260—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, fvacture, tumor, pseudoarthrosis, and failed previous fusion. The Sintea Biotech Posterior Lumbar System is apedicle screw system intended to provide immobilization and…

Read the full statement (168 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, fvacture, tumor, pseudoarthrosis, and failed previous fusion.

The Sintea Biotech Posterior Lumbar System is apedicle screw system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment ojthe 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 apedicle screw system indicatedfor the treatment ofsevere spondylolisthesis (Grades 3 and 4) of the L5-SI 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.

Also cleared against K010720

2 other devices cite the same predicate.

  • K190376PASS LP Spinal SystemMedicrea International SA · 20195 recalls
  • K103049TSRH Spinal SystemMedtronic Sofamor Danek · 2010

More from Sintea Biotech, Inc.

10 FDA decisions under this applicant name. See the company

  • K082679Laki Hand Fixation System, Model TFX.3X.06.XSintea Biotech, Inc. · 2009
  • K081631Sintea Biotech PLS Multi-Axial ScrewsSintea Biotech, Inc. · 2008
  • K072198X-Void, SpiderSintea Biotech, Inc. · 2008
  • K070181Sintea Biotech DSC/Alf Spinal System, DSC.XX.T5.XX, Alf.XX.T5.XXSintea Biotech, Inc. · 2007
  • K060513Sintea Biotech PLS Multi-Axial Screws, Model PLS.XX.T5.XSintea Biotech, Inc. · 2006

Recent decisions in MNH

The MNH category page

  • K162066Reliance Spinal Screw SystemReliance Medical Systems, LLC · 2016
  • K162801CastleLoc Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2016
  • K162143FixxSure® X-LinkInnovasis, Inc. · 2016
  • K161151Spinal fixation systemCanwell Medical Co., Ltd. · 2016
  • K162189ANAX™ 5.5 Spinal SystemU&I Corporation · 2016

https://510kreport.com/device/K020085 · printed Nov 3, 2026

Cite this page

510(k) Report. “K020085: Sintea Biotech Posterior Lumbar System, Model PLS 00.T5.X.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K020085

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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