510(k) · Cleared
ClearedGSS Pedicle Screw System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
GS Medical Co., Ltd. · MNH Orthosis, Spondylolisthesis Spinal Fixation
Cleared on Mar 8, 2006 as substantially equivalent to K001668 (D.K.M. Co., Ltd., 2000) and 1 other predicate after a 76-day review. Its family tree reaches back 3 generations to 2000. 181 later devices descend from it.
- Decided
- Mar 8, 2006
- Review
- 76 days
- Class
- Class II
- Product code
- MNH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K000319 (2000). 7 ancestors in all. 181 later devices descend from it, 8 citing it directly.
- Root · 3 generations backK000319 Ebi Xfix DFS SystemEbi, L.P. · 2000
- 2 generations backK020279 Forex Corporation, Optima, Spinal SystemForex Corp. · 2002 · Recalled
- 1 generation backK031585 U&I, Optima, Spinal SystemU&I Corp., America · 2003 · Recalled
- This deviceK053573 GSS Pedicle Screw SystemGS Medical Co., Ltd. · 2006
- Descendant · cites it directly · 140 of its ownK082509 Eos Spinal SystemKorea Bone Bank Co., Ltd. · 2008
- Descendant · cites it directly · 130 of its ownK091717 Any Plus Spinal Fixation SystemGS Medical Co., Ltd. · 2010
- Descendant · 2 generations on · 124 of its ownK100706 Venus Basic Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2010
- Descendant · 2 generations on · 123 of its ownK103085 Venus Basic Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2011
- Descendant · 2 generations on · 111 of its ownK120270 Venus Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2012
Showing 5 of 181 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 181 · See all- K082509Eos Spinal SystemKorea Bone Bank Co., Ltd. · 2008 · cites it directly140descendants
- K091717Any Plus Spinal Fixation SystemGS Medical Co., Ltd. · 2010 · cites it directly130descendants
- K100706Venus Basic Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2010 · 2 generations on124descendants
- K103085Venus Basic Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2011 · 2 generations on123descendants
- K120270Venus Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2012 · 2 generations on111descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K000319 | Ebi Xfix DFS System | Ebi, L.P. | 2000 | — |
| −2 | K020279 | Forex Corporation, Optima, Spinal System | Forex Corp. | 2002 | 4 |
| −1 | K031585 | U&I, Optima, Spinal System | U&I Corp., America | 2003 | 5 |
| 0 (this device) | K053573 | GSS Pedicle Screw System | GS Medical Co., Ltd. | 2006 | — |
| +1 | K082509 | Eos Spinal System | Korea Bone Bank Co., Ltd. | 2008 | — |
| +1 | K091717 | Any Plus Spinal Fixation System | GS Medical Co., Ltd. | 2010 | — |
| +2 | K100706 | Venus Basic Spinal Fixation System | L&K BIOMED Co., Ltd. | 2010 | — |
| +2 | K103085 | Venus Basic Spinal Fixation System | L&K BIOMED Co., Ltd. | 2011 | — |
| +2 | K120270 | Venus Spinal Fixation System | L&K BIOMED Co., Ltd. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 4 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 2 | 0 |
| 2010 | 4 | 0 |
| 2011 | 3 | 0 |
| 2012 | 7 | 0 |
| 2013 | 6 | 0 |
| 2014 | 9 | 0 |
| 2015 | 11 | 0 |
| 2016 | 8 | 0 |
| 2017 | 17 | 0 |
| 2018 | 11 | 0 |
| 2019 | 6 | 0 |
| 2020 | 12 | 0 |
| 2021 | 7 | 0 |
| 2022 | 12 | 0 |
| 2023 | 20 | 0 |
| 2024 | 16 | 0 |
| 2025 | 12 | 0 |
| 2026 | 18 | 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? (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 |
|---|---|---|---|
| * | K001668 | Global Spinal Fixation System | 2000 |
| * | K031585 | U&I, Optima, Spinal SystemSummary page 1…ubstantially equivalent in function, design, composition, material and intended used to: Global Spinal Fixation System(KO01668) and OPTIMATM, Spinal System(K03 1585) Device Description The GSS Pedicle Screw System is a top-loading multiple component, posterior spinal fixation s… | 2003 |
What descends from it? (181)
See all 1818 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K082509 | Eos Spinal System | 2008 | 140 |
| K091717 | Any Plus Spinal Fixation System | 2010 | 130 |
| K100765 | Fixpine II System | 2010 | 23 |
| K172546 | AnyPlus® Spinal Fixation System | 2017 | 12 |
| K182544 | AccelFix Spinal Fixation System | 2019 | 10 |
| K092076 | Aegis & Aegis II Spinal System | 2010 | 3 |
| K102574 | Palla M Spinal System | 2011 | 2 |
| K081108 | Monopoly Pedicle Screw System | 2008 | 0 |
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 6 years and passes through 4 companies; a new generation was cleared every 2.3 years on median.
- 2 of the 7 ancestors have a recall of any class.
- Of its descendants, K082509 (Korea Bone Bank Co., Ltd., 2008) has gone furthest, with 140 descendants of its own.
- 15 other devices also cite its predicate K001668.
How does its category compare?
All MNH devicesMNH Orthosis, Spondylolisthesis Spinal Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 GSS Pedicle Screw System is a pedicle screw system indicated for the treatment of severe Spondylolisthesis (Grade 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. In addition, the GSS Pedicle Screw System is intended to provide immobilization and stabilization…
Read the full statement (123 words)
The GSS Pedicle Screw System is a pedicle screw system indicated for the treatment of severe Spondylolisthesis (Grade 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.
In addition, the GSS Pedicle Screw System is 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/K053573 · printed Nov 4, 2026
Cite this page
510(k) Report. “K053573: GSS 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/K053573
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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