510(k) · Cleared
ClearedKatia System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shanghai Sanyou Medical Co, Ltd. · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Aug 7, 2013 as substantially equivalent to K081038 (Medtronic Sofamor Danek, 2008) and 3 other predicates after a 71-day review. Its family tree reaches back 7 generations to 1998. 1 later device descends from it.
- Decided
- Aug 7, 2013
- Review
- 71 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 7 generations to K973854 (1998). 36 ancestors in all, the oldest K792352 (1979). 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backK973854 Orion Anterior Cervical Plate SystemSofamor Danek USA,Inc. · 1998
- 6 generations backK042235 Orion Anterior Cervical Plating SystemMedtronic Sofamor Danek · 2004
- 5 generations backK042922 Venture Anterior Cervical Plating SystemMedtronic Sofamor Danek, Inc. · 2004
- 4 generations backK061274 Venture Anterior Cervical Plate SystemMedtronic Sofamor Danek · 2006
- 3 generations backK102820 Appliance, Fixation, Spinal Intervertebral BodyAlphatec Spine, Inc. · 2010 · Recalled
- 2 generations backK103137 Venus Anterior Cervical PlateVerticor, Ltd. · 2011
- 1 generation backK111132 Genesys Spine Anterior Cervical Plate SystemGenesys Spine · 2011 · Recalled
- This deviceK131512 Katia SystemShanghai Sanyou Medical Co, Ltd. · 2013
- Descendant · cites it directly · 0 of its ownK163366 Shanghai Sanyou CARMEN Cervical Fusion SystemShanghai Sanyou Medical Co, Ltd. · 2017
Most influential descendants
Showing 1 of 1 · See all- K163366Shanghai Sanyou CARMEN Cervical Fusion SystemShanghai Sanyou Medical Co, Ltd. · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K973854 | Orion Anterior Cervical Plate System | Sofamor Danek USA,Inc. | 1998 | — |
| −6 | K042235 | Orion Anterior Cervical Plating System | Medtronic Sofamor Danek | 2004 | — |
| −5 | K042922 | Venture Anterior Cervical Plating System | Medtronic Sofamor Danek, Inc. | 2004 | — |
| −4 | K061274 | Venture Anterior Cervical Plate System | Medtronic Sofamor Danek | 2006 | — |
| −3 | K102820 | Appliance, Fixation, Spinal Intervertebral Body | Alphatec Spine, Inc. | 2010 | 2 |
| −2 | K103137 | Venus Anterior Cervical Plate | Verticor, Ltd. | 2011 | — |
| −1 | K111132 | Genesys Spine Anterior Cervical Plate System | Genesys Spine | 2011 | 1 |
| 0 (this device) | K131512 | Katia System | Shanghai Sanyou Medical Co, Ltd. | 2013 | — |
| +1 | K163366 | Shanghai Sanyou CARMEN Cervical Fusion System | Shanghai Sanyou Medical Co, Ltd. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 2 | 0 |
| 1997 | 3 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 3 | 0 |
| 2004 | 5 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 4 | 0 |
| 2008 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 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? (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 |
|---|---|---|---|
| * | K081038 | Atlantis Anterior Cervical Plate SystemSummary page 2…(defined as kyphosis, lordosis, or scoliosis), 6) pseudlarthrosis, 7) failed previous fusions, and/or 8) spinal stenosis. Substantial Equivalence: K081038 - Medtronic ATLANTISe Anterior Cervical Plate System K111132 - Genesys Spine Anterior Cervical Plate System K031276… | 2008 |
| * | K111132 | Genesys Spine Anterior Cervical Plate SystemSummary page 2…7) failed previous fusions, and/or 8) spinal stenosis. Substantial Equivalence: K081038 - Medtronic ATLANTISe Anterior Cervical Plate System K111132 - Genesys Spine Anterior Cervical Plate System K031276 - Synthes Anterior Cervical Locking Plate (ACLP System) K971… | 2011 |
| * | K031276 | Synthes Anterior Cervical Locking Plate (Aclp) SystemSummary page 2…Substantial Equivalence: K081038 - Medtronic ATLANTISe Anterior Cervical Plate System K111132 - Genesys Spine Anterior Cervical Plate System K031276 - Synthes Anterior Cervical Locking Plate (ACLP System) K971883 - Synthes Small Stature Anterior Cervical Vertebrae Plate… | 2003 |
| * | K971883 | Synthes Spine Small Stature Anterior Cervical Vertebrae Plate SystemSummary page 2…nterior Cervical Plate System K111132 - Genesys Spine Anterior Cervical Plate System K031276 - Synthes Anterior Cervical Locking Plate (ACLP System) K971883 - Synthes Small Stature Anterior Cervical Vertebrae Plate System Performance Testing: Testing was completed accord… | 1997 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K163366 | Shanghai Sanyou CARMEN Cervical Fusion System | 2017 | 0 |
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 15 years and passes through 7 companies; a new generation was cleared every 1.5 years on median.
- 9 of the 36 ancestors have a recall of any class.
- Of its descendants, K163366 (Shanghai Sanyou Medical Co, Ltd., 2017) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K081038.
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. 2013, this device’s year, is highlighted.
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 Katia System is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fixation of the cervical spine (C2 - Ti). The system is indicated for use in temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with: 1)degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by…
Read the full statement (108 words)
The Katia System is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fixation of the cervical spine (C2 - Ti). The system is indicated for use in temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with: 1)degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), 2) spondylolisthesis, 3) trauma (i.e. fractures or dislocations), 4) tumors, 5) deformity (defined as kyphosis, lordlosis, or scoliosis), 6) pseudarthrosls, 7) failed previous fusions, and/or 8) spinal stenosis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131512 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131512: Katia System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131512
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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