510(k) · Cleared
ClearedAnyPlus® 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 Oct 23, 2017 as substantially equivalent to K091717 (GS Medical Co., Ltd., 2010) and 1 other predicate after a 61-day review. Its family tree reaches back 5 generations to 2000. 12 later devices descend from it.
- Decided
- Oct 23, 2017
- Review
- 61 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K000319 (2000). 13 ancestors in all, the oldest K990745 (1999). 12 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK000319 Ebi Xfix DFS SystemEbi, L.P. · 2000
- 4 generations backK020279 Forex Corporation, Optima, Spinal SystemForex Corp. · 2002 · Recalled
- 3 generations backK031585 U&I, Optima, Spinal SystemU&I Corp., America · 2003 · Recalled
- 2 generations backK053573 GSS Pedicle Screw SystemGS Medical Co., Ltd. · 2006
- 1 generation backK091717 Any Plus Spinal Fixation SystemGS Medical Co., Ltd. · 2010
- This deviceK172546 AnyPlus® Spinal Fixation SystemGS Medical Co., Ltd. · 2017
- Descendant · cites it directly · 10 of its ownK182544 AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2019
- Descendant · 2 generations on · 8 of its ownK200794 AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2020
- Descendant · 2 generations on · 4 of its ownK223565 LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System…L&K BIOMED Co., Ltd. · 2022
- Descendant · 2 generations on · 3 of its ownK230245 LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System…L&K BIOMED Co., Ltd. · 2023
- Descendant · 3 generations on · 2 of its ownK231839 CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate…L&K BIOMED Co., Ltd. · 2023
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K182544AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2019 · cites it directly10descendants
- K200794AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2020 · 2 generations on8descendants
- K223565LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd. · 2022 · 2 generations on4descendants
- K230245LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal Fixation…L&K BIOMED Co., Ltd. · 2023 · 2 generations on3descendants
- K231839CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate SystemL&K BIOMED Co., Ltd. · 2023 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K000319 | Ebi Xfix DFS System | Ebi, L.P. | 2000 | — |
| −4 | K020279 | Forex Corporation, Optima, Spinal System | Forex Corp. | 2002 | 4 |
| −3 | K031585 | U&I, Optima, Spinal System | U&I Corp., America | 2003 | 5 |
| −2 | K053573 | GSS Pedicle Screw System | GS Medical Co., Ltd. | 2006 | — |
| −1 | K091717 | Any Plus Spinal Fixation System | GS Medical Co., Ltd. | 2010 | — |
| 0 (this device) | K172546 | AnyPlus® Spinal Fixation System | GS Medical Co., Ltd. | 2017 | — |
| +1 | K182544 | AccelFix Spinal Fixation System | L&K BIOMED Co., Ltd. | 2019 | — |
| +2 | K200794 | AccelFix Spinal Fixation System | L&K BIOMED Co., Ltd. | 2020 | — |
| +2 | K223565 | LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal… | L&K BIOMED Co., Ltd. | 2022 | — |
| +2 | K230245 | LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal… | L&K BIOMED Co., Ltd. | 2023 | — |
| +3 | K231839 | CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate System | L&K BIOMED Co., Ltd. | 2023 | — |
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 |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 4 | 0 |
| 2024 | 1 | 0 |
| 2026 | 3 | 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? (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 |
|---|---|---|---|
| * | K091717 | Any Plus Spinal Fixation SystemSummary page 4…on Orthosis Product Codes: NKB KWP KWQ Predicate Device: Primary: AnyPlus® Spinal Fixation System (K091717) Secondary: GSS Pedicle Screw System (K053573) Intended Use/ Indications for Use: The AnyPlus Spi… | 2010 |
| * | K053573 | GSS Pedicle Screw SystemSummary page 4…KWQ Predicate Device: Primary: AnyPlus® Spinal Fixation System (K091717) Secondary: GSS Pedicle Screw System (K053573) Intended Use/ Indications for Use: The AnyPlus Spinal Fixation System are non-cervical spinal fixation devices… | 2006 |
What descends from it? (12)
See all 122 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 4 companies; a new generation was cleared every 2.7 years on median.
- 4 of the 13 ancestors have a recall of any class.
- Of its descendants, K182544 (L&K BIOMED Co., Ltd., 2019) has gone furthest, with 10 descendants of its own.
- 7 other devices also cite its predicate K091717.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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?
The 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 (T1 – L5),or as an anterolateral fixation system (T8 – L5). All components 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 (122 words)
The 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 (T1 – L5),or as an anterolateral fixation system (T8 – L5). All components 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 patient 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/K172546 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172546: AnyPlus® 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/K172546
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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