510(k) · Cleared
ClearedFocus Mis System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
L&K BIOMED Co., Ltd. · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Jan 4, 2012 as substantially equivalent to K100706 (L&K BIOMED Co., Ltd., 2010) and 4 other predicates after a 114-day review. Its family tree reaches back 7 generations to 1995. 26 later devices descend from it.
- Decided
- Jan 4, 2012
- Review
- 114 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 7 generations to K950697 (1995). 62 ancestors in all, the oldest K933881 (1994). 26 later devices descend from it, 4 citing it directly.
- Root · 7 generations backK950697 Depuy Motech Moss Miami Spinal System - Pedicle FixationDepuy Motech · 1995
- 6 generations backK050461 Xia 4.5 Spinal SystemStryker Spine · 2005
- 5 generations backK052761 Modification to: Xia 4.5 Spinal SystemStryker Spine · 2005
- 4 generations backK060361 Xia Spinal System, Xia 4.5 Spinal SystemStryker Spine · 2006 · Recalled
- 3 generations backK060979 Xia Titanium and 4.5 Spinal SystemsStryker Spine · 2006
- 2 generations backK082942 Modfication to: Expedium Spine SystemDepuy Spine, Inc. · 2008
- 1 generation backK090648 Viper 2 SystemDepuy Spine, Inc. · 2009
- This deviceK112643 Focus Mis SystemL&K BIOMED Co., Ltd. · 2012
- Descendant · cites it directly · 25 of its ownK120140 Focus Spinal SystemL&K BIOMED Co., Ltd. · 2012
- Descendant · 2 generations on · 18 of its ownK161766 PathLoc-L MIS Spinal SystemL&K BIOMED Co., Ltd. · 2016
- Descendant · 3 generations on · 10 of its ownK182544 AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2019
- Descendant · 4 generations on · 8 of its ownK200794 AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2020
- Descendant · 4 generations on · 4 of its ownK223565 LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System…L&K BIOMED Co., Ltd. · 2022
Showing 5 of 26 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 26 · See all- K120140Focus Spinal SystemL&K BIOMED Co., Ltd. · 2012 · cites it directly25descendants
- K161766PathLoc-L MIS Spinal SystemL&K BIOMED Co., Ltd. · 2016 · 2 generations on18descendants
- K182544AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2019 · 3 generations on10descendants
- K200794AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2020 · 4 generations on8descendants
- K223565LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd. · 2022 · 4 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K950697 | Depuy Motech Moss Miami Spinal System - Pedicle Fixation | Depuy Motech | 1995 | — |
| −6 | K050461 | Xia 4.5 Spinal System | Stryker Spine | 2005 | — |
| −5 | K052761 | Modification to: Xia 4.5 Spinal System | Stryker Spine | 2005 | — |
| −4 | K060361 | Xia Spinal System, Xia 4.5 Spinal System | Stryker Spine | 2006 | 1 |
| −3 | K060979 | Xia Titanium and 4.5 Spinal Systems | Stryker Spine | 2006 | — |
| −2 | K082942 | Modfication to: Expedium Spine System | Depuy Spine, Inc. | 2008 | — |
| −1 | K090648 | Viper 2 System | Depuy Spine, Inc. | 2009 | — |
| 0 (this device) | K112643 | Focus Mis System | L&K BIOMED Co., Ltd. | 2012 | — |
| +1 | K120140 | Focus Spinal System | L&K BIOMED Co., Ltd. | 2012 | — |
| +2 | K161766 | PathLoc-L MIS Spinal System | L&K BIOMED Co., Ltd. | 2016 | — |
| +3 | K182544 | AccelFix Spinal Fixation System | L&K BIOMED Co., Ltd. | 2019 | — |
| +4 | K200794 | AccelFix Spinal Fixation System | L&K BIOMED Co., Ltd. | 2020 | — |
| +4 | K223565 | LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal… | L&K BIOMED Co., Ltd. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 7 | 0 |
| 2001 | 3 | 0 |
| 2002 | 2 | 0 |
| 2003 | 6 | 0 |
| 2004 | 6 | 0 |
| 2005 | 7 | 0 |
| 2006 | 5 | 0 |
| 2007 | 3 | 0 |
| 2008 | 5 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 3 | 0 |
| 2019 | 2 | 0 |
| 2020 | 3 | 0 |
| 2022 | 2 | 0 |
| 2023 | 6 | 0 |
| 2024 | 1 | 0 |
| 2026 | 4 | 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? (5)
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 |
|---|---|---|---|
| * | K100706 | Venus Basic Spinal Fixation SystemSummary page 1…System (888.3070) 3. Predicate or legally marketed devices which are substantially equivalent " L&K BIOMED: VENUS BASIC Spinal Fixation System (K100706, K103085) " STRYKER SPINE: MANTIS TM Spinal System (K061813) " DEPUV SPINE: Expediumn TM MIS Spine System… | 2010 |
| * | K103085 | Venus Basic Spinal Fixation SystemSummary page 1…888.3070) 3. Predicate or legally marketed devices which are substantially equivalent " L&K BIOMED: VENUS BASIC Spinal Fixation System (K100706, K103085) " STRYKER SPINE: MANTIS TM Spinal System (K061813) " DEPUV SPINE: Expediumn TM MIS Spine System (K04 180… | 2011 |
| * | K061813 | Mantis Spinal SystemSummary page 1…which are substantially equivalent " L&K BIOMED: VENUS BASIC Spinal Fixation System (K100706, K103085) " STRYKER SPINE: MANTIS TM Spinal System (K061813) " DEPUV SPINE: Expediumn TM MIS Spine System (K04 1801 ,K090648) 4. Description of the Device… | 2006 |
| * | K041801 | Expedium Mis Spine SystemSummary page 1…BASIC Spinal Fixation System (K100706, K103085) " STRYKER SPINE: MANTIS TM Spinal System (K061813) " DEPUV SPINE: Expediumn TM MIS Spine System (K04 1801 ,K090648) 4. Description of the Device FOCUS Spinal System consists of cannulated polyscrews, straight r… | 2004 |
| * | K090648 | Viper 2 SystemSummary page 1…nal Fixation System (K100706, K103085) " STRYKER SPINE: MANTIS TM Spinal System (K061813) " DEPUV SPINE: Expediumn TM MIS Spine System (K04 1801 ,K090648) 4. Description of the Device FOCUS Spinal System consists of cannulated polyscrews, straight rods, curv… | 2009 |
What descends from it? (26)
See all 264 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 7 months on median.
- 6 of the 62 ancestors have a recall of any class.
- Of its descendants, K120140 (L&K BIOMED Co., Ltd., 2012) has gone furthest, with 25 descendants of its own.
- 5 other devices also cite its predicate K100706.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 FOCUS Spinal System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine. And the FOCUS Spinal System can be used in an open approach and a percutaneous approach with MIS instrumentation. The FOCUS Spinal System is intended for noncervical pedicle fixation and…
Read the full statement (194 words)
The FOCUS Spinal System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine. And the FOCUS Spinal System can be used in an open approach and a percutaneous approach with MIS instrumentation.
The FOCUS Spinal System is intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and for lordosis); tumor; pseudarthrosis; and failed previous fusion in skeletally mature patients.
When used in a percutaneous approach with MIS Instrumentation, the FOCUS Spinal Systems are intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and for lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112643 · printed Nov 3, 2026
Cite this page
510(k) Report. “K112643: Focus Mis System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K112643
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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