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 Sep 8, 2005 as substantially equivalent to K013823 (Howmedica Osteonics Corp., 2001) and 3 other predicates after a 29-day review. Its family tree reaches back 3 generations to 1999. 202 later devices descend from it.
- Decided
- Sep 8, 2005
- Review
- 29 days
- Class
- Class II
- Product code
- KWP
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K984251 (1999). 11 ancestors in all, the oldest K951725 (1995). 202 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK984251 Xia Spine SystemHowmedica, Inc. · 1999
- 2 generations backK012027 Modification to Xia Spine SystemHowmedica Osteonics · 2001
- 1 generation backK013688 Modification to Xia Spinal SystemHowmedica Osteonics Corp. · 2001
- This deviceK052181 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 · 4 generations on · 111 of its ownK120270 Venus Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2012
- Descendant · 3 generations on · 110 of its ownK092631 Mantis Redux Spinal SystemStryker Spine · 2009
Showing 5 of 202 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 202 · See all- 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
- K120270Venus Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2012 · 4 generations on111descendants
- K092631Mantis Redux Spinal SystemStryker Spine · 2009 · 3 generations on110descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K984251 | Xia Spine System | Howmedica, Inc. | 1999 | — |
| −2 | K012027 | Modification to Xia Spine System | Howmedica Osteonics | 2001 | — |
| −1 | K013688 | Modification to Xia Spinal System | Howmedica Osteonics Corp. | 2001 | — |
| 0 (this device) | 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 | — |
| +4 | K120270 | Venus Spinal Fixation System | L&K BIOMED Co., Ltd. | 2012 | — |
| +3 | K092631 | Mantis Redux Spinal System | Stryker Spine | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 3 | 0 |
| 2010 | 2 | 0 |
| 2011 | 3 | 0 |
| 2012 | 4 | 0 |
| 2013 | 5 | 0 |
| 2014 | 6 | 0 |
| 2015 | 9 | 0 |
| 2016 | 4 | 0 |
| 2017 | 12 | 0 |
| 2018 | 14 | 0 |
| 2019 | 11 | 0 |
| 2020 | 17 | 0 |
| 2021 | 7 | 0 |
| 2022 | 14 | 0 |
| 2023 | 26 | 0 |
| 2024 | 25 | 0 |
| 2025 | 18 | 0 |
| 2026 | 20 | 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? (4)
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 |
|---|---|---|---|
| * | K013823 | Xia Spinal SystemSummary page 1…Pedicle Screw Spinal System 21 CFR §888.3070 Predicate Device Information: K013823 Stryker Spine Xia Spinal System K013688 OSS and Opus Rods - Use with Xia… | 2001 |
| * | K013688 | Modification to Xia Spinal SystemSummary page 1…21 CFR §888.3070 Predicate Device Information: K013823 Stryker Spine Xia Spinal System K013688 OSS and Opus Rods - Use with Xia Spinal System… | 2001 |
| * | K002505 | Xia Spine SystemSummary page 1…K013688 OSS and Opus Rods - Use with Xia Spinal System K002505 Line Extension - Xia Spine System K043473 Line Extension - Xia Spinal System… | 2000 |
| * | K043473 | Modification to Xia Spinal SystemSummary page 1…Spinal System K002505 Line Extension - Xia Spine System K043473 Line Extension - Xia Spinal System Predicate Device Identification The Xia® Titanium Spinal System consists of Monoaxial and Po… | 2005 |
What descends from it? (202)
See all 2022 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 6 years and passes through 4 companies; a new generation was cleared every 2.4 years on median.
- None of the 11 ancestors has a recall.
- Of its descendants, K070631 (Stryker Spine, 2007) has gone furthest, with 201 descendants of its own.
- 17 other devices also cite its predicate K013823.
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 (277 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 6mm diameter rods from the DIAPASON TM Spinal System and OPUS TM Spinal System are intended to be used with the other components of the Xia® Titanium Spinal System. The Titanium Multi-Axial Cross Connectors are intended to be used with the other components of the Xia® Titanium Spinal System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052181 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052181: 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/K052181
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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