510(k) · Cleared
ClearedCastleLoc-S Posterior Cervical Fixation System; LnK Posterior Cervical Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
L&K BIOMED Co., Ltd. · NKG Posterior Cervical Screw System
Cleared on Nov 3, 2016 as substantially equivalent to K151755 (Stryker Corporation, 2015) and 1 other predicate after a 94-day review. Its family tree reaches back 15 generations to 1985. 1 of the 53 devices in its family, counting itself, has a Class I recall. 12 later devices descend from it.
- Decided
- Nov 3, 2016
- Review
- 94 days
- Class
- Class II
- Product code
- NKG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 15 generations to K853033 (1985). 40 ancestors in all. 12 later devices descend from it, 2 citing it directly. 1 of the 53 devices in this family, counting this one, has a Class I recall.
- Root · 15 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 11 generations between
- 3 generations backK142741 OASYS SystemStryker Corporation · 2015
- 2 generations backK150753 OASYS SystemStryker Corporation · 2015
- 1 generation backK151755 OASYS (r) SystemStryker Corporation · 2015
- This deviceK162136 CastleLoc-S Posterior Cervical Fixation System; LnK Posterior…L&K BIOMED Co., Ltd. · 2016
- Descendant · cites it directly · 11 of its ownK200793 LnK Posterior Cervical Fixation System and CastleLoc-S Posterior…L&K BIOMED Co., Ltd. · 2020
- Descendant · 2 generations on · 10 of its ownK210035 ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical…Aegis Spine · 2021
- Descendant · 2 generations on · 6 of its ownK221050 ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation…Aegis Spine, Inc. · 2022
- Descendant · 3 generations on · 3 of its ownK223719 Paeon Anterior Cervical Plate System, Elatus Lumbar Plate SystemAegis Spine, Inc. · 2023
- Descendant · 3 generations on · 2 of its ownK231839 CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate…L&K BIOMED Co., Ltd. · 2023
Show all 15 generations
- Root · 15 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 14 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
- 13 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
- 12 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
- 11 generations backK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
- 10 generations backK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
- 9 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
- 8 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
- 7 generations backK072568 Modification to Oasys SystemStryker Spine · 2007
- 6 generations backK080143 Modification to Stryker Spine Oasys SystemStryker Spine · 2008
- 5 generations backK093670 Modification to: Oasys SystemStryker Spine · 2010 · Recalled (Class I)
- 4 generations backK111719 Oasys Spinal SystemStryker Spine · 2012
- 3 generations backK142741 OASYS SystemStryker Corporation · 2015
- 2 generations backK150753 OASYS SystemStryker Corporation · 2015
- 1 generation backK151755 OASYS (r) SystemStryker Corporation · 2015
- This deviceK162136 CastleLoc-S Posterior Cervical Fixation System; LnK Posterior…L&K BIOMED Co., Ltd. · 2016
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K093670 Modification to: Oasys System5 generations back · 2010
Most influential descendants
Showing 5 of 12 · See all- K200793LnK Posterior Cervical Fixation System and CastleLoc-S Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd. · 2020 · cites it directly11descendants
- K210035ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System, MegaCerfix…Aegis Spine · 2021 · 2 generations on10descendants
- K221050ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon Anterior…Aegis Spine, Inc. · 2022 · 2 generations on6descendants
- K223719Paeon Anterior Cervical Plate System, Elatus Lumbar Plate SystemAegis Spine, Inc. · 2023 · 3 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 |
|---|---|---|---|---|---|
| −15 | K853033 | Hartshill Rect & Wires, Spinal Fixation System | A.W. Showell (Surgicraft), Ltd. | 1985 | — |
| −14 | K965221 | Ransford Cervical Fixation System | Surgicraft, Ltd. | 1997 | — |
| −13 | K982322 | Synthes Spine Occipital-Cervical Plate/Rod and Hook System | Synthes (Usa) | 1998 | — |
| −12 | K002733 | Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2000 | — |
| −11 | K013222 | Summit Occipito-Cervico- Thoracic (Oct) Spinal System | Depuyacromed | 2001 | — |
| −10 | K022190 | Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2002 | — |
| −9 | K030103 | Summit Oct Spinal System Minipolyaxial Screws | Depuyacromed | 2003 | — |
| −8 | K041203 | Summit Oct Spinal System | Depuy Spine, Inc. | 2004 | — |
| −7 | K072568 | Modification to Oasys System | Stryker Spine | 2007 | — |
| −6 | K080143 | Modification to Stryker Spine Oasys System | Stryker Spine | 2008 | — |
| −5 | K093670 | Modification to: Oasys System | Stryker Spine | 2010 | Class I |
| −4 | K111719 | Oasys Spinal System | Stryker Spine | 2012 | — |
| −3 | K142741 | OASYS System | Stryker Corporation | 2015 | — |
| −2 | K150753 | OASYS System | Stryker Corporation | 2015 | — |
| −1 | K151755 | OASYS (r) System | Stryker Corporation | 2015 | — |
| 0 (this device) | K162136 | CastleLoc-S Posterior Cervical Fixation System; LnK Posterior Cervical… | L&K BIOMED Co., Ltd. | 2016 | — |
| +1 | K200793 | LnK Posterior Cervical Fixation System and CastleLoc-S Posterior Cervical… | L&K BIOMED Co., Ltd. | 2020 | — |
| +2 | K210035 | ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System… | Aegis Spine | 2021 | — |
| +2 | K221050 | ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon… | Aegis Spine, Inc. | 2022 | — |
| +3 | K223719 | Paeon Anterior Cervical Plate System, Elatus Lumbar Plate System | Aegis Spine, Inc. | 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 |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 4 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2015 | 4 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 6 | 0 |
| 2024 | 1 | 0 |
| 2026 | 2 | 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.
1 device in this family has a Class I recall. 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 NKG device
- #1 K252327 CMORE® CT System; CMORE® CT System Navigated…score 19.6 · 22 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 |
|---|---|---|---|
| * | K151755 | OASYS (r) SystemSummary page 4…oc-S Posterior Cervical Fixation System. 4. Predicate or legally marketed devices which are substantially equivalent Primary Predicate: OASYS® System (K151755) Additional Device: LnK Posterior Cervical Fixation System (K143278)… | 2015 |
| * | K143278 | LnK Posterior Cervical Fixation SystemSummary page 4…ices which are substantially equivalent Primary Predicate: OASYS® System (K151755) Additional Device: LnK Posterior Cervical Fixation System (K143278) K162136… | 2015 |
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? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K093670Modification to: Oasys SystemStryker Spine · 2010 · 5 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 31 years and passes through 8 companies; a new generation was cleared every 1.3 years on median.
- 3 of the 40 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K200793 (L&K BIOMED Co., Ltd., 2020) has gone furthest, with 11 descendants of its own.
- 4 other devices also cite its predicate K151755.
How does its category compare?
All NKG devicesNKG Posterior Cervical Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · NKG
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NKG
58in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NKG
2in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NKG
153in 2025
MAUDE reports naming product code NKG, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 17 | 71 | 0 | 4 |
| 2016 | 16 | 87 | 0 | 73 |
| 2017 | 15 | 108 | 0 | 99 |
| 2018 | 12 | 61 | 1 | 127 |
| 2019 | 8 | 50 | 1 | 214 |
| 2020 | 14 | 59 | 2 | 236 |
| 2021 | 7 | 56 | 0 | 704 |
| 2022 | 7 | 108 | 0 | 175 |
| 2023 | 10 | 58 | 0 | 131 |
| 2024 | 3 | 100 | 0 | 206 |
| 2025 | 6 | 58 | 0 | 153 |
| 2026 | 4 | 169 | 0 | — |
What is it indicated for?
CastleLoc-S Posterior Cervical Fixation System: The CastleLoc-S Posterior Cervical Fixation System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the cervical spine (C1 to C7) and the thoracic spine (T1-T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudoarthrosis); tumors…
Read the full statement (344 words)
CastleLoc-S Posterior Cervical Fixation System:
The CastleLoc-S Posterior Cervical Fixation System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the cervical spine (C1 to C7) and the thoracic spine (T1-T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudoarthrosis); tumors involving the cervical spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The CasteLoc-S Posterior Cervical Fixation System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.
The CastleLoc-S Posterior Cervical Fixation System can be linked to the LnK Spinal Fixation System and PathLoc-C Posterior Cervical Fixation System via rod to rod connector and transitional rod.
LnK Posterior Cervical Fixation System:
The LnK Posterior Cervical Fixation System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the cervical spine (C1 to C7) and the thoracic spine (T1-T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudoarthrosis); tumors involving the cervical spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The LnK Posterior Cervical Fixation System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion
The LnK Posterior Cervical Fixation System can be linked to the LnK Spinal Fixation System and PathLoc-C Posterior Cervical Fixation System via rod to rod connector and transitional rod.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162136 · printed Nov 3, 2026
Cite this page
510(k) Report. “K162136: CastleLoc-S Posterior Cervical Fixation System; LnK Posterior Cervical Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K162136
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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