510(k) · Cleared
ClearedXia Spine System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Howmedica, Inc. · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Feb 24, 1999 after an 89-day review. The FDA summary names its predicate without a number. 1 of the 373 devices in its family, counting itself, has a Class I recall. 372 later devices descend from it.
- Decided
- Feb 24, 1999
- Review
- 89 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 0
372 later devices descend from it, 14 citing it directly. 1 of the 373 devices in this family, counting this one, has a Class I recall.
- This deviceK984251 Xia Spine SystemHowmedica, Inc. · 1999
- Descendant · cites it directly · 206 of its ownK012027 Modification to Xia Spine SystemHowmedica Osteonics · 2001
- Descendant · cites it directly · 205 of its ownK013688 Modification to Xia Spinal SystemHowmedica Osteonics Corp. · 2001
- Descendant · 2 generations on · 202 of its ownK052181 Modification to Xia Spinal SystemStryker Spine · 2005
- Descendant · 3 generations on · 201 of its ownK070631 Device Modification to Radius Spinal SystemStryker Spine · 2007
- Descendant · 4 generations on · 200 of its ownK082608 Radius Spinal System, Vitallium Rod #486613601Stryker Spine · 2008
Showing 5 of 372 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub3 generations on · 2021
Most influential descendants
Showing 5 of 372 · See all- K012027Modification to Xia Spine SystemHowmedica Osteonics · 2001 · cites it directly206descendants
- K013688Modification to Xia Spinal SystemHowmedica Osteonics Corp. · 2001 · cites it directly205descendants
- K052181Modification to Xia Spinal SystemStryker Spine · 2005 · 2 generations on202descendants
- K070631Device Modification to Radius Spinal SystemStryker Spine · 2007 · 3 generations on201descendants
- K082608Radius Spinal System, Vitallium Rod #486613601Stryker Spine · 2008 · 4 generations on200descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K984251 | Xia Spine System | Howmedica, Inc. | 1999 | — |
| +1 | K012027 | Modification to Xia Spine System | Howmedica Osteonics | 2001 | — |
| +1 | K013688 | Modification to Xia Spinal System | Howmedica Osteonics Corp. | 2001 | — |
| +2 | K052181 | Modification to Xia Spinal System | Stryker Spine | 2005 | — |
| +3 | K070631 | Device Modification to Radius Spinal System | Stryker Spine | 2007 | — |
| +4 | K082608 | Radius Spinal System, Vitallium Rod #486613601 | Stryker Spine | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 5 | 0 |
| 2008 | 6 | 0 |
| 2009 | 7 | 0 |
| 2010 | 3 | 0 |
| 2011 | 6 | 0 |
| 2012 | 13 | 0 |
| 2013 | 7 | 0 |
| 2014 | 14 | 0 |
| 2015 | 16 | 0 |
| 2016 | 14 | 0 |
| 2017 | 18 | 0 |
| 2018 | 19 | 0 |
| 2019 | 21 | 0 |
| 2020 | 28 | 0 |
| 2021 | 15 | 1 |
| 2022 | 23 | 0 |
| 2023 | 39 | 0 |
| 2024 | 40 | 0 |
| 2025 | 32 | 0 |
| 2026 | 37 | 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.
Top candidate predicates for a new KWQ device
- #1 K233640 Segmental Plating System (SPS);IdentiTi SPS…score 21.9 · 31 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | — | Howmedica’s BWM Spine System Named without a submission number | |
| * | — | Synthes® Spine’s Universal Spinal System (USS) Named without a submission number | |
| * | — | MOSS Miami Spinal System by DePuy Named without a submission number |
What descends from it? (372)
See all 37214 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K012027 | Modification to Xia Spine System | 2001 | 206 |
| K013688 | Modification to Xia Spinal System | 2001 | 205 |
| K061813 | Mantis Spinal System | 2006 | 135 |
| K133350 | Revere Stabilization System | 2014 | 93 |
| K001080 | Spine System Evolution | 2000 | 62 |
| K062785 | LTD Polyaxial Fixation System | 2006 | 41 |
| K071438 | PSS System | 2007 | 39 |
| K072116 | Savannah Lumbar Percutaneous Stabilization System | 2008 | 24 |
| K091587 | Mercury Spinal System | 2009 | 10 |
| K081978 | Reliance Spinal Screw System | 2009 | 8 |
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 · 3 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K012027 (Howmedica Osteonics, 2001) has gone furthest, with 206 descendants of its own.
How does its category compare?
All KWQ devicesKWQ Appliance, Fixation, Spinal Intervertebral Body: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KWQ
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KWQ
64in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWQ
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWQ
248in 2025
MAUDE reports naming product code KWQ, 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 | 27 | 101 | 2 | 288 |
| 2008 | 32 | 70 | 33 | 348 |
| 2009 | 23 | 90 | 35 | 355 |
| 2010 | 23 | 104 | 2 | 691 |
| 2011 | 22 | 95 | 5 | 415 |
| 2012 | 26 | 90 | 7 | 544 |
| 2013 | 22 | 88 | 6 | 796 |
| 2014 | 17 | 124 | 0 | 546 |
| 2015 | 25 | 102 | 2 | 562 |
| 2016 | 15 | 121 | 9 | 502 |
| 2017 | 20 | 67 | 8 | 492 |
| 2018 | 22 | 95 | 1 | 341 |
| 2019 | 26 | 81 | 0 | 298 |
| 2020 | 26 | 55 | 0 | 400 |
| 2021 | 17 | 59 | 0 | 591 |
| 2022 | 18 | 85 | 0 | 392 |
| 2023 | 16 | 59 | 0 | 320 |
| 2024 | 17 | 64 | 0 | 419 |
| 2025 | 7 | 64 | 0 | 248 |
| 2026 | 10 | 76 | 0 | — |
What is it indicated for?
The XIA Spine 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 which is fused; (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 (282 words)
The XIA Spine 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 which is fused; (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. Pedicle screw fixation is limited to L3 to S1 or the ilium.
When used as a pedicle screw fixation system, the XIA Spine 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 sacrall/iliac screw fixation system, the XIA Spine System is indicated for patients with degenerative disc disease of the thoracic, lumbar, 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. When used in the posterior non-pedicle indication the Xia system is indicated for use in the thoracic to sacral spine. When used in the anterior indication the Xia system is indicated for use in the thoracic and lumbar spine.
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/K984251 · printed Nov 6, 2026
Cite this page
510(k) Report. “K984251: Xia 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/K984251
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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