510(k) · Cleared
ClearedNeoplate Spine Anterior Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neoortho Productos Orthopedicos S/A · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on May 14, 2014 as substantially equivalent to K030327 (Medtronic Sofamor Danek, 2003) after a 261-day review. Its family tree reaches back 1 generation to 2003.
- Decided
- May 14, 2014
- Review
- 261 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K030327 (2003). No later device cites it as a predicate yet.
- Root · 1 generation backK030327 Zephir Anterior Cervical SystemMedtronic Sofamor Danek · 2003
- This deviceK132653 Neoplate Spine Anterior Fixation SystemNeoortho Productos Orthopedicos S/A · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K030327 | Zephir Anterior Cervical System | Medtronic Sofamor Danek | 2003 | — |
| 0 (this device) | K132653 | Neoplate Spine Anterior Fixation System | Neoortho Productos Orthopedicos S/A | 2014 | — |
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 |
|---|---|---|---|
| * | K030327 | Zephir Anterior Cervical SystemSummary page 1…ode KWQ Classification Panel Orthopedic Regulation Numbers 21 CFR § 888.3060 Predicate Device K(030327 Zephir Anterior Cervical System by Medtronic Sofamor Danek Device Description The NeoOrtho… | 2003 |
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?
- Its one ancestor has no recall.
- 12 other devices also cite its predicate K030327.
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. 2014, 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 Nco~rtho NEOPLATE Spine Anterior Fixation System is intended for anterior interbody screw/plate fixation of the cervical spine. The indications and contraindications of spinal instrumentation systems should be well understood by the surgeon. The system is incdicated for use in the 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…
Read the full statement (135 words)
The Nco~rtho NEOPLATE Spine Anterior Fixation System is intended for anterior interbody screw/plate fixation of the cervical spine. The indications and contraindications of spinal instrumentation systems should be well understood by the surgeon. The system is incdicated for use in the 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 paitient history and radiographic studies), 2) trauma, (including fractures), 3) tumors. 4)deformity (defined by kyphosis, lordosis, or scoliosis), 5) pseudarilirosis, and/or 6) failed previous fusions.
Note: this device system is intended for anterior cervical intervertebral body fusions only.
Warning: This device is not approved lor screw attachment to the posterior elements (pedicles) of the cervical. thoracic or Ilmbar spine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132653 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132653: Neoplate Spine Anterior Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132653
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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