510(k) · Cleared
ClearedXia Spine System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Howmedica Osteonics Corp. · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on May 11, 2000 after a 21-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 14 later devices descend from it.
- Decided
- May 11, 2000
- Review
- 21 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 0
14 later devices descend from it, 3 citing it directly.
- This deviceK001272 Xia Spine SystemHowmedica Osteonics Corp. · 2000
- Descendant · cites it directly · 6 of its ownK120469 Erisma-LPClariance · 2012
- Descendant · 2 generations on · 5 of its ownK153326 Erisma-LP Spinal Fixation SystemClariance, Sas · 2016 · Recalled
- Descendant · cites it directly · 5 of its ownK142835 Iliad Pedicle Screw System and Zenius Pedicle Screw SystemMedyssey USA, Inc. · 2015
- Descendant · 2 generations on · 2 of its ownK222229 Advanced LumFix Spinal Fixation SystemCG Bio Co., Ltd. · 2023
- Descendant · 2 generations on · 2 of its ownK170163 Erisma® LP Spinal Fixation SystemClariance, Sas · 2017
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K120469Erisma-LPClariance · 2012 · cites it directly6descendants
- K153326Erisma-LP Spinal Fixation SystemClariance, Sas · 2016 · 2 generations on5descendants
- K142835Iliad Pedicle Screw System and Zenius Pedicle Screw SystemMedyssey USA, Inc. · 2015 · cites it directly5descendants
- K222229Advanced LumFix Spinal Fixation SystemCG Bio Co., Ltd. · 2023 · 2 generations on2descendants
- K170163Erisma® LP Spinal Fixation SystemClariance, Sas · 2017 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K001272 | Xia Spine System | Howmedica Osteonics Corp. | 2000 | — |
| +1 | K120469 | Erisma-LP | Clariance | 2012 | — |
| +2 | K153326 | Erisma-LP Spinal Fixation System | Clariance, Sas | 2016 | 1 |
| +1 | K142835 | Iliad Pedicle Screw System and Zenius Pedicle Screw System | Medyssey USA, Inc. | 2015 | — |
| +2 | K222229 | Advanced LumFix Spinal Fixation System | CG Bio Co., Ltd. | 2023 | — |
| +2 | K170163 | Erisma® LP Spinal Fixation System | Clariance, Sas | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KWQ? 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (14)
See all 143 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?
- Of its descendants, K120469 (Clariance, 2012) has gone furthest, with 6 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 | — |
https://510kreport.com/device/K001272 · printed Nov 6, 2026
Cite this page
510(k) Report. “K001272: 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/K001272
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026