510(k) · Cleared
ClearedSlimplicity Solo Anterior Cervical Plate System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spinal USA, LLC · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Jul 11, 2012 as substantially equivalent to K042544 (Depuy Spine, Inc., 2004) and 2 other predicates after a 294-day review. Its family tree reaches back 4 generations to 2003.
- Decided
- Jul 11, 2012
- Review
- 294 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K031276 (2003). 9 ancestors in all, the oldest K792352 (1979). No later device cites it as a predicate yet.
- Root · 4 generations backK031276 Synthes Anterior Cervical Locking Plate (Aclp) SystemSynthes (Usa) · 2003
- 3 generations backK033844 Synthes Anterior Cervical Compression SystemSynthes (Usa) · 2004
- 2 generations backK050451 Synthes Vectra SystemSynthes Spine Co.Lp · 2005 · Recalled
- 1 generation backK071667 Synthes Vectra-One SystemSynthes Spine · 2007 · Recalled
- This deviceK112748 Slimplicity Solo Anterior Cervical Plate SystemSpinal USA, LLC · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K031276 | Synthes Anterior Cervical Locking Plate (Aclp) System | Synthes (Usa) | 2003 | — |
| −3 | K033844 | Synthes Anterior Cervical Compression System | Synthes (Usa) | 2004 | — |
| −2 | K050451 | Synthes Vectra System | Synthes Spine Co.Lp | 2005 | 3 |
| −1 | K071667 | Synthes Vectra-One System | Synthes Spine | 2007 | 3 |
| 0 (this device) | K112748 | Slimplicity Solo Anterior Cervical Plate System | Spinal USA, LLC | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 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? (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 |
|---|---|---|---|
| * | K042544 | Uniplate Anterior Cervical Plate SystemSummary page 2…rial of both the plate and screws is the same as the predicates. Sterilization is the same as the predicates. Predicate Devices: Uniplate Anterior Cervical Plate System K042544 Synthes Anterior CSLP System K030866 Synthes Vectra-One System K071667… | 2004 |
| * | K030866 | Synthes Anterior CSLP SystemSummary page 2…the same as the predicates. Sterilization is the same as the predicates. Predicate Devices: Uniplate Anterior Cervical Plate System K042544 Synthes Anterior CSLP System K030866 Synthes Vectra-One System K071667… | 2003 |
| * | K071667 | Synthes Vectra-One SystemSummary page 2…ization is the same as the predicates. Predicate Devices: Uniplate Anterior Cervical Plate System K042544 Synthes Anterior CSLP System K030866 Synthes Vectra-One System K071667 5.2 === Page 3… | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
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 9 years and passes through 4 companies; a new generation was cleared every 2.7 years on median.
- 2 of the 9 ancestors have a recall of any class.
- 25 other devices also cite its predicate K042544.
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. 2012, 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 Slimplicity Solo Anterior Cervical Plate System is intended for anterior cervical fixation to the cervical spine C2-C7 for the following indications: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, failed previous fusion, spondylolisthesis, and spinal stenosis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112748 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112748: Slimplicity Solo Anterior Cervical Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112748
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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