510(k) · Cleared
ClearedOptio-C Anterior Cervical System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zimmer Spine, Inc. · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Sep 23, 2014 as substantially equivalent to K031276 (Synthes (Usa), 2003) and 3 other predicates after a 109-day review. Its family tree reaches back 2 generations to 1993. 2 later devices descend from it.
- Decided
- Sep 23, 2014
- Review
- 109 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K926453 (1993). 7 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK926453 Synthes (U.S.a.) Anterior Cervical Vertebrae PlateSynthes (Usa) · 1993
- 1 generation backK971883 Synthes Spine Small Stature Anterior Cervical Vertebrae Plate SystemSynthes (Usa) · 1997 · Recalled
- This deviceK141500 Optio-C Anterior Cervical SystemZimmer Spine, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK230608 SPICCA Stand-Alone Cervical Fusion CagesSouthern Medical (Pty), Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK152239 Zero-P Natural Plate SystemSynthes (Usa), LLC · 2015
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K926453 | Synthes (U.S.a.) Anterior Cervical Vertebrae Plate | Synthes (Usa) | 1993 | — |
| −1 | K971883 | Synthes Spine Small Stature Anterior Cervical Vertebrae Plate System | Synthes (Usa) | 1997 | 1 |
| 0 (this device) | K141500 | Optio-C Anterior Cervical System | Zimmer Spine, Inc. | 2014 | — |
| +1 | K230608 | SPICCA Stand-Alone Cervical Fusion Cages | Southern Medical (Pty), Ltd. | 2023 | — |
| +1 | K152239 | Zero-P Natural Plate System | Synthes (Usa), LLC | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2023 | 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 |
|---|---|---|---|
| * | K031276 | Synthes Anterior Cervical Locking Plate (Aclp) SystemSummary page 5…ct Code Predicate Device Name Clearance Date K031276 Cleared July 2, 2003… | 2003 |
| * | K030866 | Synthes Anterior CSLP SystemSummary page 5…Cleared July 2, 2003 KWQ ® K030866 Synthes Spine Anterior CSLP System 21 CFR… | 2003 |
| * | K971883 | Synthes Spine Small Stature Anterior Cervical Vertebrae Plate SystemSummary page 5…Cleared April 18, 2003 Synthes Spine § 888.3060 K971883 Cleared Oct 16, 1997 ® Trinica Anterio… | 1997 |
| * | K012305 | Modification to: Trinica Anterior Cervical Plate SystemSummary page 5…Cleared Oct 16, 1997 ® Trinica Anterior Cervical Plate System KWQ K012305 Zimmer Spine, Inc. 21 CFR… | 2001 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 21 years and passes through 2 companies; a new generation was cleared every 16.9 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K230608 (Southern Medical (Pty), Ltd., 2023) has gone furthest, with 0 descendants of its own.
- 13 other devices also cite its predicate K031276.
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?
When Optio-C Anterior Cervical Plate is used with structural allograft/autograft it is intended for one-level anterior screw fixation of the cervical spine (C2-T1). The implant has been designed for use with structural allograft/autograft to provide stabilization as an adjunct to cervical fusion. Indications for use of the Optio-C Anterior Plate with structural allograft/autograft include degenerative disc disease (defined as neck pain of discogenic…
Read the full statement (234 words)
When Optio-C Anterior Cervical Plate is used with structural allograft/autograft it is intended for one-level anterior screw fixation of the cervical spine (C2-T1). The implant has been designed for use with structural allograft/autograft to provide stabilization as an adjunct to cervical fusion. Indications for use of the Optio-C Anterior Plate with structural allograft/autograft include degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), spinal stenosis, deformity (i.e., kyphosis, lordosis or scoliosis), tumor, pseudarthrosis or failed previous fusion. The Optio-C Anterior Cervical Plate is intended to be used with a structural allograft/autograft and with three Optio-C bone screws.
When Optio-C Anterior Cervical Plate is used with an Optio-C PEEK IBF Spacer it becomes an Optio-C Anterior Cervical Intervertebral Body Fusion Device (IBFD), indicated for stand-alone anterior cervical interbody fusion procedures in skeletally mature patients with cervical degenerative disc disease at one level from C2 to T1. Degenerative disc disease (DDD) is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Optio-C IBFD is comprised of one Optio-C PEEK IBF Spacer, one Optio-C Anterior Cervical Plate and three Optio-C bone screws.
The Optio-C IBFD is to be used with autograft and implanted via an open, anterior approach in patients who have had six weeks of non-operative treatment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141500 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141500: Optio-C Anterior Cervical System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141500
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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