510(k) · Cleared
ClearedModification to Xia Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Spine · KWP Appliance, Fixation, Spinal Interlaminal
Cleared on Jan 12, 2005 as substantially equivalent to K002858 (Howmedica Osteonics Corp., 2000) and 1 other predicate after a 27-day review. Its family tree reaches back 1 generation to 2000. 289 later devices descend from it.
- Decided
- Jan 12, 2005
- Review
- 27 days
- Class
- Class II
- Product code
- KWP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K002858 (2000). 2 ancestors in all. 289 later devices descend from it, 11 citing it directly.
- Root · 1 generation backK002858 Xia Spine SystemHowmedica Osteonics Corp. · 2000
- This deviceK043473 Modification to Xia Spinal SystemStryker Spine · 2005
- Descendant · cites it directly · 202 of its ownK052181 Modification to Xia Spinal SystemStryker Spine · 2005
- Descendant · cites it directly · 201 of its ownK070631 Device Modification to Radius Spinal SystemStryker Spine · 2007
- Descendant · 2 generations on · 200 of its ownK082608 Radius Spinal System, Vitallium Rod #486613601Stryker Spine · 2008
- Descendant · 3 generations on · 169 of its ownK091291 Xia 3 Spinal System, Uniplanner/Reduction Screws & Vitallium RodStryker Spine · 2009
- Descendant · cites it directly · 135 of its ownK061813 Mantis Spinal SystemStryker Spine · 2006 · Recalled
Showing 5 of 289 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 289 · See all- K052181Modification to Xia Spinal SystemStryker Spine · 2005 · cites it directly202descendants
- K070631Device Modification to Radius Spinal SystemStryker Spine · 2007 · cites it directly201descendants
- K082608Radius Spinal System, Vitallium Rod #486613601Stryker Spine · 2008 · 2 generations on200descendants
- K091291Xia 3 Spinal System, Uniplanner/Reduction Screws & Vitallium RodStryker Spine · 2009 · 3 generations on169descendants
- K061813Mantis Spinal SystemStryker Spine · 2006 · cites it directly135descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K002858 | Xia Spine System | Howmedica Osteonics Corp. | 2000 | — |
| 0 (this device) | K043473 | Modification to Xia Spinal System | Stryker Spine | 2005 | — |
| +1 | K052181 | Modification to Xia Spinal System | Stryker Spine | 2005 | — |
| +1 | K070631 | Device Modification to Radius Spinal System | Stryker Spine | 2007 | — |
| +2 | K082608 | Radius Spinal System, Vitallium Rod #486613601 | Stryker Spine | 2008 | — |
| +3 | K091291 | Xia 3 Spinal System, Uniplanner/Reduction Screws & Vitallium Rod | Stryker Spine | 2009 | — |
| +1 | K061813 | Mantis Spinal System | Stryker Spine | 2006 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 5 | 0 |
| 2008 | 1 | 0 |
| 2009 | 4 | 0 |
| 2010 | 4 | 0 |
| 2011 | 6 | 0 |
| 2012 | 11 | 0 |
| 2013 | 10 | 0 |
| 2014 | 9 | 0 |
| 2015 | 12 | 0 |
| 2016 | 8 | 0 |
| 2017 | 23 | 0 |
| 2018 | 18 | 0 |
| 2019 | 17 | 0 |
| 2020 | 24 | 0 |
| 2021 | 9 | 0 |
| 2022 | 15 | 0 |
| 2023 | 34 | 0 |
| 2024 | 29 | 0 |
| 2025 | 24 | 0 |
| 2026 | 23 | 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 KWP? 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? (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 |
|---|---|---|---|
| * | K002858 | Xia Spine SystemSummary page 1…Email: Simona.Voickstryker.com Date Summary Prepared: January 5, 2005 Predicate Device Identification: K002858 Xia Spine System K013823 Xia Spinal System Predicate Device Description The Xia T… | 2000 |
| * | K013823 | Xia Spinal SystemSummary page 1…Prepared: January 5, 2005 Predicate Device Identification: K002858 Xia Spine System K013823 Xia Spinal System Predicate Device Description The Xia Titanium Spinal System consists of Monoaxial and Polyaxial Screws, Washer… | 2001 |
What descends from it? (289)
See all 28911 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K052181 | Modification to Xia Spinal System | 2005 | 202 |
| K070631 | Device Modification to Radius Spinal System | 2007 | 201 |
| K061813 | Mantis Spinal System | 2006 | 135 |
| K073151 | Mantis Spinal System | 2007 | 111 |
| K092631 | Mantis Redux Spinal System | 2009 | 110 |
| K102235 | Mantis Spinal System & Mantis Redux Spinal System | 2010 | 109 |
| K071945 | S4 Spinal System | 2007 | 95 |
| K062698 | Trio + Spinal System | 2006 | 88 |
| K133188 | Mantis & Mantis Redux Spinal System, Radius Spinal System, Trio & Trio+ Spinal Fixation… | 2013 | 84 |
| K110842 | Atlas Spine Pedicle Screw System | 2011 | 4 |
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?
How does its category compare?
All KWP devicesKWP Appliance, Fixation, Spinal Interlaminal: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KWP
9in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · KWP
113in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWP
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWP
494in 2025
MAUDE reports naming product code KWP, 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 | 14 | 96 | 2 | 210 |
| 2008 | 13 | 50 | 1 | 594 |
| 2009 | 12 | 89 | 23 | 682 |
| 2010 | 14 | 186 | 2 | 474 |
| 2011 | 12 | 67 | 6 | 792 |
| 2012 | 18 | 112 | 1 | 918 |
| 2013 | 12 | 99 | 3 | 1,090 |
| 2014 | 13 | 138 | 0 | 1,022 |
| 2015 | 9 | 113 | 1 | 1,348 |
| 2016 | 0 | — | 3 | 1,379 |
| 2017 | 0 | — | 0 | 864 |
| 2018 | 0 | — | 1 | 657 |
| 2019 | 0 | — | 2 | 518 |
| 2020 | 0 | — | 0 | 796 |
| 2021 | 0 | — | 0 | 525 |
| 2022 | 0 | — | 2 | 335 |
| 2023 | 0 | — | 0 | 332 |
| 2024 | 0 | — | 0 | 436 |
| 2025 | 0 | — | 0 | 494 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Xia Spinal System is intended for use in the noncervical spine. When used as a pedicle screw fixation system, the Xia Spinal System is intended for patients: (a) having severe spondylolisthesis (Grades 3 and 4) at the fifth lumbar - first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine; and (d) who are having the device…
Read the full statement (269 words)
The Xia Spinal System is intended for use in the noncervical spine. When used as a pedicle screw fixation system, the Xia Spinal System is intended for patients: (a) having severe spondylolisthesis (Grades 3 and 4) at the fifth lumbar - first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine; and (d) who are having the device removed after the development of a solid fusion mass.
When used as a.pedicle screw fixation system, the Xia Spinal System is also 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 neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
When used as an anterior screw fixation system or a posterior hook and sacral/iliac screw fixation system, the Xia Spinal System is indicated for patients with degenerative disc disease which is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, fracture, spinal stenosis, spinal deformities such as scoliosis, kyphosis, lordosis, tumor, pseudoarthrosis or revision of failed fusion attempts.
The 6 mm diameter rods from the DIAPASONTM Spinal System and OPUS Spinal System are intended to be used with the other components of Xia®Titanium Spinal System. The Titanium Multi-Axis Cross-Connectors are intended to be used with the other components of Xia® Titanium Spinal System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043473 · printed Nov 6, 2026
Cite this page
510(k) Report. “K043473: Modification to Xia Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K043473
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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