510(k) · Cleared
ClearedXingtm Spine System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Implanova Co., Ltd. · MNH Orthosis, Spondylolisthesis Spinal Fixation
Cleared on Dec 12, 2011 as substantially equivalent to K001668 (D.K.M. Co., Ltd., 2000) and 4 other predicates after a 152-day review. Its family tree reaches back 4 generations to 2000.
- Decided
- Dec 12, 2011
- Review
- 152 days
- Class
- Class II
- Product code
- MNH
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 4 generations to K000319 (2000). 13 ancestors in all. No later device cites it as a predicate yet.
- 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 backK060702 4CIS Vane Spine SystemSolco Biomedical Co., Ltd. · 2006
- This deviceK111995 Xingtm Spine SystemImplanova Co., Ltd. · 2011
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 | K060702 | 4CIS Vane Spine System | Solco Biomedical Co., Ltd. | 2006 | — |
| 0 (this device) | K111995 | Xingtm Spine System | Implanova Co., Ltd. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 4 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2007 | 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? (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 |
|---|---|---|---|
| * | K001668 | Global Spinal Fixation SystemSummary page 3…SYSTEM Numberk NIA K(001668 K(031585 K(060702 K(041808 K(071857 Device Orthosis, Orthosis… | 2000 |
| * | K031585 | U&I, Optima, Spinal SystemSummary page 2…is substantially equivalent to the following predicate devices: * OPTIMATM, Spinal System (U & [ Co., Ltd; KOO 1668) * Global Spinal Fixation System (D.K.M. Co., Ltd; K03 1585) S4C15® Vane Spine System (Solco Biomedical Co., Ltd.; K060702) *Title®2 Spinal System(ENDLUS, INC; K04 1808) *DELTA… | 2003 |
| * | K060702 | 4CIS Vane Spine SystemSummary page 2…* OPTIMATM, Spinal System (U & [ Co., Ltd; KOO 1668) * Global Spinal Fixation System (D.K.M. Co., Ltd; K03 1585) S4C15® Vane Spine System (Solco Biomedical Co., Ltd.; K060702) *Title®2 Spinal System(ENDLUS, INC; K04 1808) *DELTA SPINAL FUSION SYSTEM(JEMO SPINE, LLC; K07 1857) Comparis… | 2006 |
| * | K041808 | Endius Title 2 Polyaxial Spinal SystemSummary page 2…) * Global Spinal Fixation System (D.K.M. Co., Ltd; K03 1585) S4C15® Vane Spine System (Solco Biomedical Co., Ltd.; K060702) *Title®2 Spinal System(ENDLUS, INC; K04 1808) *DELTA SPINAL FUSION SYSTEM(JEMO SPINE, LLC; K07 1857) Comparison to Predicate Devices: The subject device, Xing" S… | 2004 |
| * | K071857 | Delta Spinal Fusion SystemSummary page 2…S4C15® Vane Spine System (Solco Biomedical Co., Ltd.; K060702) *Title®2 Spinal System(ENDLUS, INC; K04 1808) *DELTA SPINAL FUSION SYSTEM(JEMO SPINE, LLC; K07 1857) Comparison to Predicate Devices: The subject device, Xing" Spine System, is substantially equivalent to OPTIMATM, Spinal Sys… | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
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 11 years and passes through 5 companies; a new generation was cleared every 3.0 years on median.
- 4 of the 13 ancestors have a recall of any class.
- 15 other devices also cite its predicate K001668.
How does its category compare?
All MNH devicesMNH Orthosis, Spondylolisthesis Spinal Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 XingTM Spine 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 XingTM Spine System is intended to provide immobilization and stabilization of spinal…
Read the full statement (121 words)
The XingTM Spine 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 XingTM Spine 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/K111995 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111995: Xingtm Spine System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111995
Report an extraction error
Are you the manufacturer?
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