510(k) · Cleared
ClearedXia Stainless Steel System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Howmedica Osteonics Corp. · KWP Appliance, Fixation, Spinal Interlaminal
Cleared on Sep 24, 2001 after a 28-day review. The FDA summary names its predicate without a number. 1 of the 909 devices in its family, counting itself, has a Class I recall. 908 later devices descend from it.
- Decided
- Sep 24, 2001
- Review
- 28 days
- Class
- Class II
- Product code
- KWP
- Recalls
- None
- Predicates
- 0
908 later devices descend from it, 10 citing it directly. 1 of the 909 devices in this family, counting this one, has a Class I recall.
- This deviceK012870 Xia Stainless Steel SystemHowmedica Osteonics Corp. · 2001
- Descendant · cites it directly · 889 of its ownK053115 Xia Spinal SystemStryker Spine · 2005
- Descendant · 2 generations on · 734 of its ownK060361 Xia Spinal System, Xia 4.5 Spinal SystemStryker Spine · 2006 · Recalled
- Descendant · 3 generations on · 710 of its ownK060979 Xia Titanium and 4.5 Spinal SystemsStryker Spine · 2006
- Descendant · cites it directly · 547 of its ownK061202 Revere Stabilization SystemGlobus Medical, Inc. · 2006
- Descendant · 4 generations on · 518 of its ownK082942 Modfication to: Expedium Spine SystemDepuy Spine, Inc. · 2008
Showing 5 of 908 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub4 generations on · 2021
Most influential descendants
Showing 5 of 908 · See all- K053115Xia Spinal SystemStryker Spine · 2005 · cites it directly889descendants
- K060361Xia Spinal System, Xia 4.5 Spinal SystemStryker Spine · 2006 · 2 generations on734descendants
- K060979Xia Titanium and 4.5 Spinal SystemsStryker Spine · 2006 · 3 generations on710descendants
- K061202Revere Stabilization SystemGlobus Medical, Inc. · 2006 · cites it directly547descendants
- K082942Modfication to: Expedium Spine SystemDepuy Spine, Inc. · 2008 · 4 generations on518descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K012870 | Xia Stainless Steel System | Howmedica Osteonics Corp. | 2001 | — |
| +1 | K053115 | Xia Spinal System | Stryker Spine | 2005 | — |
| +2 | 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 | — |
| +1 | K061202 | Revere Stabilization System | Globus Medical, Inc. | 2006 | — |
| +4 | K082942 | Modfication to: Expedium Spine System | Depuy Spine, Inc. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 3 | 0 |
| 2006 | 10 | 0 |
| 2007 | 10 | 0 |
| 2008 | 13 | 0 |
| 2009 | 20 | 0 |
| 2010 | 14 | 0 |
| 2011 | 20 | 0 |
| 2012 | 34 | 0 |
| 2013 | 36 | 0 |
| 2014 | 35 | 0 |
| 2015 | 42 | 0 |
| 2016 | 42 | 0 |
| 2017 | 58 | 0 |
| 2018 | 60 | 0 |
| 2019 | 53 | 0 |
| 2020 | 54 | 0 |
| 2021 | 44 | 1 |
| 2022 | 61 | 0 |
| 2023 | 88 | 0 |
| 2024 | 73 | 0 |
| 2025 | 70 | 0 |
| 2026 | 68 | 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.
- 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 |
|---|---|---|---|
| * | — | Xia Spinal System Named without a submission number |
What descends from it? (908)
See all 90810 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K053115 | Xia Spinal System | 2005 | 889 |
| K061202 | Revere Stabilization System | 2006 | 547 |
| K061854 | Xia Titanium Spinal System and Xia Stainless Steel Spinal System | 2006 | 216 |
| K063428 | Xia Stainless Steel Spinal System | 2006 | 204 |
| K070631 | Device Modification to Radius Spinal System | 2007 | 201 |
| K052971 | Stryker Spine Trio Spinal Fixation System | 2005 | 112 |
| K073437 | Thor Anterior Plating System | 2008 | 102 |
| K080773 | Thor Anterior Plating System | 2008 | 101 |
| K062698 | Trio + Spinal System | 2006 | 88 |
| K051973 | Modification to: Xia Stainless Steel System | 2005 | 0 |
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.
- K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 4 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K053115 (Stryker Spine, 2005) has gone furthest, with 889 descendants of its own.
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 Stainless Steel System is intended for use in the noncervical spine. When used as a pedicle screw fixation system, the XIA Spine 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…
Read the full statement (227 words)
The Xia Stainless Steel System is intended for use in the noncervical spine. When used as a pedicle screw fixation system, the XIA Spine 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 Stainless Steel 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 an anterior screw fixation system or a posterior hook and sacral/iliac screw fixation system, the Xia Stainless Steel 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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K012870 · printed Nov 4, 2026
Cite this page
510(k) Report. “K012870: Xia Stainless Steel System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K012870
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026