510(k) · Cleared
ClearedCastleLoc Spinal Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
L&K BIOMED Co., Ltd. · MNH Orthosis, Spondylolisthesis Spinal Fixation
Cleared on Nov 3, 2016 as substantially equivalent to K103085 (L&K BIOMED Co., Ltd., 2011) after a 29-day review. Its family tree reaches back 7 generations to 2000. 4 later devices descend from it.
- Decided
- Nov 3, 2016
- Review
- 29 days
- Class
- Class II
- Product code
- MNH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K000319 (2000). 21 ancestors in all, the oldest K980485 (1998). 4 later devices descend from it, 1 citing it directly.
- Root · 7 generations backK000319 Ebi Xfix DFS SystemEbi, L.P. · 2000
- 6 generations backK020279 Forex Corporation, Optima, Spinal SystemForex Corp. · 2002 · Recalled
- 5 generations backK031585 U&I, Optima, Spinal SystemU&I Corp., America · 2003 · Recalled
- 4 generations backK053573 GSS Pedicle Screw SystemGS Medical Co., Ltd. · 2006
- 3 generations backK082509 Eos Spinal SystemKorea Bone Bank Co., Ltd. · 2008
- 2 generations backK100706 Venus Basic Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2010
- 1 generation backK103085 Venus Basic Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2011
- This deviceK162801 CastleLoc Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2016
- Descendant · cites it directly · 3 of its ownK173645 JASPER Spinal Fixation SystemGbs Commonwealth Co., Ltd. · 2018
- Descendant · 2 generations on · 2 of its ownK182059 Prase MIS Spinal SystemGbs Commonwealth Co., Ltd. · 2018
- Descendant · 2 generations on · 1 of its ownK190762 The JASPER Spinal Fixation System IIGbs Commonwealth Co., Ltd. · 2019
- Descendant · 3 generations on · 0 of its ownK232292 Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd. · 2023
Most influential descendants
Showing 4 of 4 · See all- K173645JASPER Spinal Fixation SystemGbs Commonwealth Co., Ltd. · 2018 · cites it directly3descendants
- K182059Prase MIS Spinal SystemGbs Commonwealth Co., Ltd. · 2018 · 2 generations on2descendants
- K190762The JASPER Spinal Fixation System IIGbs Commonwealth Co., Ltd. · 2019 · 2 generations on1descendant
- K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd. · 2023 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K000319 | Ebi Xfix DFS System | Ebi, L.P. | 2000 | — |
| −6 | K020279 | Forex Corporation, Optima, Spinal System | Forex Corp. | 2002 | 4 |
| −5 | K031585 | U&I, Optima, Spinal System | U&I Corp., America | 2003 | 5 |
| −4 | K053573 | GSS Pedicle Screw System | GS Medical Co., Ltd. | 2006 | — |
| −3 | K082509 | Eos Spinal System | Korea Bone Bank Co., Ltd. | 2008 | — |
| −2 | K100706 | Venus Basic Spinal Fixation System | L&K BIOMED Co., Ltd. | 2010 | — |
| −1 | K103085 | Venus Basic Spinal Fixation System | L&K BIOMED Co., Ltd. | 2011 | — |
| 0 (this device) | K162801 | CastleLoc Spinal Fixation System | L&K BIOMED Co., Ltd. | 2016 | — |
| +1 | K173645 | JASPER Spinal Fixation System | Gbs Commonwealth Co., Ltd. | 2018 | — |
| +2 | K182059 | Prase MIS Spinal System | Gbs Commonwealth Co., Ltd. | 2018 | — |
| +2 | K190762 | The JASPER Spinal Fixation System II | Gbs Commonwealth Co., Ltd. | 2019 | — |
| +3 | K232292 | Peridot-EX Expandable Intervertebral Body Fusion System | Gbs Commonwealth Co., Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2000 | 4 | 0 |
| 2003 | 1 | 0 |
| 2005 | 4 | 0 |
| 2006 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 2 | 0 |
| 2019 | 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? (1)
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 |
|---|---|---|---|
| * | K103085 | Venus Basic Spinal Fixation SystemSummary page 4…new type of screws and adding new brand name. 4. Predicate or legally marketed devices which are substantially equivalent Primary Predicate Device: K103085 VENUS BASIC Spinal Fixation System (LnK Basic Spinal Fixation System) 5. Description of the Device The Castl… | 2011 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K173645 | JASPER Spinal Fixation System | 2018 | 3 |
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 16 years and passes through 6 companies; a new generation was cleared every 2.3 years on median.
- 3 of the 21 ancestors have a recall of any class.
- Of its descendants, K173645 (Gbs Commonwealth Co., Ltd., 2018) has gone furthest, with 3 descendants of its own.
- 5 other devices also cite its predicate K103085.
How does its category compare?
All MNH devicesMNH Orthosis, Spondylolisthesis Spinal Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 CastleLoc Spinal Fixation System is a pedicle screw system 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 CastleLoc Spinal Fixation System is intended to provide immobilization…
Read the full statement (123 words)
The CastleLoc Spinal Fixation System is a pedicle screw system 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 CastleLoc Spinal Fixation 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/K162801 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162801: CastleLoc 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/K162801
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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