510(k) · Cleared
ClearedXia Spinal System C-C Adaptor
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 Nov 16, 1999 after an 89-day review. The FDA summary names its predicate without a number. 63 later devices descend from it.
- Decided
- Nov 16, 1999
- Review
- 89 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 0
63 later devices descend from it, 1 citing it directly.
- This deviceK992792 Xia Spinal System C-C AdaptorHowmedica Osteonics Corp. · 1999
- Descendant · cites it directly · 62 of its ownK001080 Spine System EvolutionAesculap, Inc. · 2000
- Descendant · 2 generations on · 61 of its ownK112551 S4 Spinal SystemAesculap Implant System, Inc. · 2011
- Descendant · 2 generations on · 51 of its ownK123352 S4 Spinal SystemAesculap Implant Systems, Inc. · 2012
- Descendant · 3 generations on · 44 of its ownK130291 S4 Spinal SystemAesculap Implant System, Inc. · 2013
- Descendant · 4 generations on · 39 of its ownK182377 CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd. · 2018
Showing 5 of 63 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 63 · See all- K001080Spine System EvolutionAesculap, Inc. · 2000 · cites it directly62descendants
- K112551S4 Spinal SystemAesculap Implant System, Inc. · 2011 · 2 generations on61descendants
- K123352S4 Spinal SystemAesculap Implant Systems, Inc. · 2012 · 2 generations on51descendants
- K130291S4 Spinal SystemAesculap Implant System, Inc. · 2013 · 3 generations on44descendants
- K182377CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd. · 2018 · 4 generations on39descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K992792 | Xia Spinal System C-C Adaptor | Howmedica Osteonics Corp. | 1999 | — |
| +1 | K001080 | Spine System Evolution | Aesculap, Inc. | 2000 | — |
| +2 | K112551 | S4 Spinal System | Aesculap Implant System, Inc. | 2011 | — |
| +2 | K123352 | S4 Spinal System | Aesculap Implant Systems, Inc. | 2012 | — |
| +3 | K130291 | S4 Spinal System | Aesculap Implant System, Inc. | 2013 | — |
| +4 | K182377 | CarboClear® Pedicle Screw System | CarboFix Orthopedics, Ltd. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 3 | 0 |
| 2017 | 6 | 0 |
| 2018 | 3 | 0 |
| 2019 | 4 | 0 |
| 2020 | 6 | 0 |
| 2021 | 3 | 0 |
| 2022 | 1 | 0 |
| 2023 | 8 | 0 |
| 2024 | 11 | 0 |
| 2025 | 6 | 0 |
| 2026 | 6 | 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 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? (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 L-Connector Named without a submission number |
What descends from it? (63)
See all 631 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K001080 | Spine System Evolution | 2000 | 62 |
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, K001080 (Aesculap, Inc., 2000) has gone furthest, with 62 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 subject components, Howmedica Osteonics® Xia™ Spinal System C-C Adaptor, are single-use devices which are sold non-sterile and are intended for use only with the other titanium alloy components of the commercially available Howmedica Osteonics® Xia™ Spinal System. 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…
Read the full statement (320 words)
The subject components, Howmedica Osteonics® Xia™ Spinal System C-C Adaptor, are single-use devices which are sold non-sterile and are intended for use only with the other titanium alloy components of the commercially available Howmedica Osteonics® Xia™ Spinal System.
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 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™ 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 neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (psuedoarthrosis).
When used as an anterior screw fixation system or a posterior hook and sacral/iliac fixation system, the Xia™ Spinal 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, psuedoarthrosis or revision of failed fusion attempts. When used in the posterior non-pedicle indication the Xia™ Spinal System is indicated for use in the thoracic to sacral spine. When used in the anterior indication the Xia™ Spinal 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/K992792 · printed Nov 6, 2026
Cite this page
510(k) Report. “K992792: Xia Spinal System C-C Adaptor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K992792
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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