510(k) · Cleared
ClearedShiraz-Anterior System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spine Next America · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Mar 4, 2004 as substantially equivalent to K021880 (Depuyacromed, 2002) after a 73-day review. Its family tree reaches back 3 generations to 1998.
- Decided
- Mar 4, 2004
- Review
- 73 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K983583 (1998). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK983583 Depuy Acromed Moss and Moss Miami Spinal SystemsDepuy, Inc. · 1998
- 2 generations backK013296 Moss Miami Spinal SystemsDepuyacromed · 2001
- 1 generation backK021880 Crossover Cross Connector (Moss Miami Spine System)Depuyacromed · 2002
- This deviceK033965 Shiraz-Anterior SystemSpine Next America · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K983583 | Depuy Acromed Moss and Moss Miami Spinal Systems | Depuy, Inc. | 1998 | — |
| −2 | K013296 | Moss Miami Spinal Systems | Depuyacromed | 2001 | — |
| −1 | K021880 | Crossover Cross Connector (Moss Miami Spine System) | Depuyacromed | 2002 | — |
| 0 (this device) | K033965 | Shiraz-Anterior System | Spine Next America | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 2 | 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 |
|---|---|---|---|
| * | K021880 | Crossover Cross Connector (Moss Miami Spine System)Summary page 1…Name: Spinal Fixation System Classification Names: Spinal intervertebral body fixation orthosis PREDICATE DEVICE Moss Miami [K02 1880, cleared June 26, 2002]. This summary of 5 10(k) safety and effectiveness information is being submitted in accordance with the r… | 2002 |
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 6 years and passes through 3 companies; a new generation was cleared every 1.7 years on median.
- None of the 5 ancestors has a recall.
- 3 other devices also cite its predicate K021880.
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?
When used as a pedicle screw fixation system, the SHIRAZ Systems are intended for treatment of severe spondylolisthesis (Grades 3 and 4) at the fifth lumbar - first sacral (L5-S1) vertebral joint in skeletally mature patients receiving fusion by autogenous bone grafting having implaits attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. When used as a pedicle screw fixation system…
Read the full statement (202 words)
When used as a pedicle screw fixation system, the SHIRAZ Systems are intended for treatment of severe spondylolisthesis (Grades 3 and 4) at the fifth lumbar - first sacral (L5-S1) vertebral joint in skeletally mature patients receiving fusion by autogenous bone grafting having implaits attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.
When used as a pedicle screw fixation system, the SHIRAZ Systems are 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 (pseudoarthrosis).
When used as a posterior, noncervical hook, and/or sacral/iliac screws fixation system, or as an bi-lateral anterior, thoracic/lumbar screw fixation system, the SHIRAZ Systems are intended to treat scoliosis, kyphosis and lordosis, fracture, loss of stability due to tumor, spinal stenosis, spondylolisthesis, a previously failed fusion surgery or degenerative disc disease (i.e., disogenic back pain with degeneration of the disc, confirmed by patient history and radiographic studies).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033965 · printed Nov 4, 2026
Cite this page
510(k) Report. “K033965: Shiraz-Anterior System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K033965
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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