510(k) · Cleared
ClearedSynster Pedicle Screw System Synster Plus Pedicle Screw System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bm Korea Co., Ltd. · MNH Orthosis, Spondylolisthesis Spinal Fixation
Cleared on May 9, 2012 as substantially equivalent to K100373 (Kyung Won Medical Co., Ltd., 2010) and 2 other predicates after a 93-day review. Its family tree reaches back 6 generations to 1995. 3 later devices descend from it.
- Decided
- May 9, 2012
- Review
- 93 days
- Class
- Class II
- Product code
- MNH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K951116 (1995). 31 ancestors in all, the oldest K933881 (1994). 3 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK951116 Acromed Pedicle ScrewAcromed Corp. · 1995
- 5 generations backK963639 Acromed Pedicle ScrewAcromed Corp. · 1996
- 4 generations backK982511 Depuy Motech Moss Miami Spinal SystemsDepuy, Inc. · 1998
- 3 generations backK030383 Modification to Moss Miami Spinal System Polyaxial ScrewsDepuyacromed · 2003
- 2 generations backK033352 Vertebron PSS Pedicle Screw SystemVertebron, Inc. · 2004
- 1 generation backK043152 Vertebron PSS Pedicle Screw SystemVertebron, Inc. · 2005
- This deviceK120353 Synster Pedicle Screw System Synster Plus Pedicle Screw SystemBm Korea Co., Ltd. · 2012
- Descendant · cites it directly · 2 of its ownK143110 GALAXY MIS Screw SystemBm Korea · 2015
- Descendant · 2 generations on · 1 of its ownK201788 EDEN Spinal Fixation SystemJmt Co., Ltd. · 2022
- Descendant · 3 generations on · 0 of its ownK230762 EDEN Spinal Fixation MIS SystemJmt Co., Ltd. · 2023
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K951116 | Acromed Pedicle Screw | Acromed Corp. | 1995 | — |
| −5 | K963639 | Acromed Pedicle Screw | Acromed Corp. | 1996 | — |
| −4 | K982511 | Depuy Motech Moss Miami Spinal Systems | Depuy, Inc. | 1998 | — |
| −3 | K030383 | Modification to Moss Miami Spinal System Polyaxial Screws | Depuyacromed | 2003 | — |
| −2 | K033352 | Vertebron PSS Pedicle Screw System | Vertebron, Inc. | 2004 | — |
| −1 | K043152 | Vertebron PSS Pedicle Screw System | Vertebron, Inc. | 2005 | — |
| 0 (this device) | K120353 | Synster Pedicle Screw System Synster Plus Pedicle Screw System | Bm Korea Co., Ltd. | 2012 | — |
| +1 | K143110 | GALAXY MIS Screw System | Bm Korea | 2015 | — |
| +2 | K201788 | EDEN Spinal Fixation System | Jmt Co., Ltd. | 2022 | — |
| +3 | K230762 | EDEN Spinal Fixation MIS System | Jmt Co., Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
| 2000 | 5 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 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? (3)
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 |
|---|---|---|---|
| * | K100373 | Tyche Pedicle Screw SystemSummary page 1…features, operational principle and material composition when compared to the predicate devices cleared under the follows: Tyche® Pedicle Screw System (K100373) OPTIMA TMSpinal System (K024096) VERTEBRON pSSTM Pedicle Screw System (K043152) k~BjMK®… | 2010 |
| * | K024096 | Optima, Spinal SystemSummary page 1…material composition when compared to the predicate devices cleared under the follows: Tyche® Pedicle Screw System (K100373) OPTIMA TMSpinal System (K024096) VERTEBRON pSSTM Pedicle Screw System (K043152) k~BjMK® oa Medical ComPany… | 2003 |
| * | K043152 | Vertebron PSS Pedicle Screw SystemSummary page 1…ate devices cleared under the follows: Tyche® Pedicle Screw System (K100373) OPTIMA TMSpinal System (K024096) VERTEBRON pSSTM Pedicle Screw System (K043152) k~BjMK® oa Medical ComPany… | 2005 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K143110 | GALAXY MIS Screw System | 2015 | 2 |
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 17 years and passes through 5 companies; a new generation was cleared every 1.8 years on median.
- 3 of the 31 ancestors have a recall of any class.
- Of its descendants, K143110 (Bm Korea, 2015) has gone furthest, with 2 descendants of its own.
How does its category compare?
All MNH devicesMNH Orthosis, Spondylolisthesis Spinal Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
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?
The SYNSTER® Pedicle Screw System and the SYNSTER® PLUS Pedicle Screw System are non-cervical, pedicle screw systems indicated for the treatment of severe Spondylolisthesis (Grade 3 and 4) of the L5-S1 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. In addition, the SYNSTER® Pedicle…
Read the full statement (137 words)
The SYNSTER® Pedicle Screw System and the SYNSTER® PLUS Pedicle Screw System are non-cervical, pedicle screw systems indicated for the treatment of severe Spondylolisthesis (Grade 3 and 4) of the L5-S1 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.
In addition, the SYNSTER® Pedicle Screw System and the SYNSTER® PLUS Pedicle Screw System are 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)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120353 · printed Nov 4, 2026
Cite this page
510(k) Report. “K120353: Synster Pedicle Screw System Synster Plus Pedicle Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K120353
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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