510(k) · Cleared
ClearedAny Plus Spinal Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
GS Medical Co., Ltd. · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Jan 25, 2010 as substantially equivalent to K053573 (GS Medical Co., Ltd., 2006) and 2 other predicates after a 228-day review. Its family tree reaches back 4 generations to 2000. 130 later devices descend from it.
- Decided
- Jan 25, 2010
- Review
- 228 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K000319 (2000). 12 ancestors in all, the oldest K990745 (1999). 130 later devices descend from it, 8 citing it directly.
- Root · 4 generations backK000319 Ebi Xfix DFS SystemEbi, L.P. · 2000
- 3 generations backK020279 Forex Corporation, Optima, Spinal SystemForex Corp. · 2002 · Recalled
- 2 generations backK031585 U&I, Optima, Spinal SystemU&I Corp., America · 2003 · Recalled
- 1 generation backK053573 GSS Pedicle Screw SystemGS Medical Co., Ltd. · 2006
- This deviceK091717 Any Plus Spinal Fixation SystemGS Medical Co., Ltd. · 2010
- Descendant · cites it directly · 111 of its ownK120270 Venus Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2012
- Descendant · 2 generations on · 75 of its ownK123549 Polaris Spinal System - Ballista II Percutaneous Screw Placement…Biomet Spine (Aka Ebi, LLC) · 2013 · Recalled
- Descendant · 3 generations on · 70 of its ownK131615 Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC) · 2013
- Descendant · 3 generations on · 67 of its ownK133746 Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC) · 2014 · Recalled
- Descendant · 2 generations on · 33 of its ownK143363 VENUS Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2015
Showing 5 of 130 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 130 · See all- K120270Venus Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2012 · cites it directly111descendants
- K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemBiomet Spine (Aka Ebi, LLC) · 2013 · 2 generations on75descendants
- K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC) · 2013 · 3 generations on70descendants
- K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC) · 2014 · 3 generations on67descendants
- K143363VENUS Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2015 · 2 generations on33descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K000319 | Ebi Xfix DFS System | Ebi, L.P. | 2000 | — |
| −3 | K020279 | Forex Corporation, Optima, Spinal System | Forex Corp. | 2002 | 4 |
| −2 | K031585 | U&I, Optima, Spinal System | U&I Corp., America | 2003 | 5 |
| −1 | K053573 | GSS Pedicle Screw System | GS Medical Co., Ltd. | 2006 | — |
| 0 (this device) | K091717 | Any Plus Spinal Fixation System | GS Medical Co., Ltd. | 2010 | — |
| +1 | K120270 | Venus Spinal Fixation System | L&K BIOMED Co., Ltd. | 2012 | — |
| +2 | K123549 | Polaris Spinal System - Ballista II Percutaneous Screw Placement System | Biomet Spine (Aka Ebi, LLC) | 2013 | 2 |
| +3 | K131615 | Polaris Spinal System | Biomet Spine (Aka Ebi, LLC) | 2013 | — |
| +3 | K133746 | Polaris Spinal System | Biomet Spine (Aka Ebi, LLC) | 2014 | 1 |
| +2 | K143363 | VENUS Spinal Fixation System | L&K BIOMED Co., Ltd. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 5 | 0 |
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 3 | 0 |
| 2013 | 2 | 0 |
| 2014 | 6 | 0 |
| 2015 | 8 | 0 |
| 2016 | 1 | 0 |
| 2017 | 9 | 0 |
| 2018 | 9 | 0 |
| 2019 | 6 | 0 |
| 2020 | 12 | 0 |
| 2021 | 6 | 0 |
| 2022 | 10 | 0 |
| 2023 | 16 | 0 |
| 2024 | 15 | 0 |
| 2025 | 11 | 0 |
| 2026 | 16 | 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 NKB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new NKB device
- #1 K223494 CD Horizon Spinal Systemscore 40.4 · 30 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K053573 | GSS Pedicle Screw SystemSummary page 1…Class Il/Class III: orthosis, spondyloisthesis spinal fixation, 888.3070, MNH, MNI, NKB Predicate Devices: GSS Pedicle Screw System (K053573), Synthes Pangea System (K052123) INCOMPASS SPINAL FIXATION SYSTEM (K021564) Dev… | 2006 |
| * | K052123 | Synthes Pangea SystemSummary page 1…nal fixation, 888.3070, MNH, MNI, NKB Predicate Devices: GSS Pedicle Screw System (K053573), Synthes Pangea System (K052123) INCOMPASS SPINAL FIXATION SYSTEM (K021564) Device Description Device Description: The AnyPlus Spin… | 2005 |
| * | K021564 | Incompass Spinal Fixation SystemSummary page 1…icate Devices: GSS Pedicle Screw System (K053573), Synthes Pangea System (K052123) INCOMPASS SPINAL FIXATION SYSTEM (K021564) Device Description Device Description: The AnyPlus Spinal Fixation System consists of and Statment of… | 2002 |
What descends from it? (130)
See all 1308 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K120270 | Venus Spinal Fixation System | 2012 | 111 |
| K172546 | AnyPlus® Spinal Fixation System | 2017 | 12 |
| K122145 | Lanx Spinal Fixation System | 2012 | 7 |
| K143110 | GALAXY MIS Screw System | 2015 | 2 |
| K133063 | Santis Pedicle Screw System | 2014 | 2 |
| K121568 | Dali Spinal Fixation System | 2012 | 1 |
| K243073 | AnyPlus Navigated Instruments System | 2024 | 0 |
| K141695 | Acrosspine Pedicle Screw System | 2014 | 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 10 years and passes through 4 companies; a new generation was cleared every 2.7 years on median.
- 4 of the 12 ancestors have a recall of any class.
- Of its descendants, K120270 (L&K BIOMED Co., Ltd., 2012) has gone furthest, with 111 descendants of its own.
- 7 other devices also cite its predicate K053573.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · NKB
24in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NKB
61in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NKB
1in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · NKB
1,171in 2025
MAUDE reports naming product code NKB, 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 | 38 | 87 | 4 | 34 |
| 2008 | 36 | 59 | 5 | 82 |
| 2009 | 44 | 71 | 33 | 171 |
| 2010 | 37 | 111 | 4 | 462 |
| 2011 | 48 | 84 | 3 | 577 |
| 2012 | 60 | 79 | 13 | 1,747 |
| 2013 | 35 | 73 | 0 | 1,962 |
| 2014 | 46 | 90 | 3 (1) | 1,671 |
| 2015 | 55 | 90 | 3 | 1,446 |
| 2016 | 50 | 84 | 1 | 1,585 |
| 2017 | 63 | 69 | 1 | 1,618 |
| 2018 | 56 | 61 | 3 | 1,684 |
| 2019 | 39 | 84 | 1 | 1,915 |
| 2020 | 48 | 68 | 1 | 2,076 |
| 2021 | 32 | 61 | 0 | 1,745 |
| 2022 | 34 | 88 | 5 | 1,339 |
| 2023 | 44 | 72 | 2 | 919 |
| 2024 | 39 | 57 | 3 | 1,614 |
| 2025 | 24 | 61 | 1 | 1,171 |
| 2026 | 30 | 91 | 3 | — |
What is it indicated for?
AnyPlus Spinal Fixation System are non-cervical spinal fixation devices intended for use as posterior pedicle screw fixation systems (T1 -S2), a posterior hook fixation system (T 1-5), or as a anterolateral fixation system (T8-L_5). All components in the system are limited to skeletally mature patients. System components are to be used for immobilization and stabilization of the spine as an adjunct to fusion. These devices are indicated for all of the…
Read the full statement (120 words)
AnyPlus Spinal Fixation System are non-cervical spinal fixation devices intended for use as posterior pedicle screw fixation systems (T1 -S2), a posterior hook fixation system (T 1-5), or as a anterolateral fixation system (T8-L_5). All components in the system are limited to skeletally mature patients. System components are to be used for immobilization and stabilization of the spine as an adjunct to fusion. These devices are indicated for all of the following indications regardless of the intended use: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis, Scheuermann's Disease), tumor, stenosis, pseudoarthrosis, and failed previous fusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091717 · printed Nov 6, 2026
Cite this page
510(k) Report. “K091717: Any Plus Spinal Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K091717
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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