510(k) · Cleared
Recalled · Class II · 2015Exactech Ambassador
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Exactech, Inc. · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Feb 27, 2015 as substantially equivalent to K071667 (Synthes Spine, 2007) and 2 other predicates after a 72-day review. Its family tree reaches back 4 generations to 2003. 7 later devices descend from it. It has been recalled once.
- Decided
- Feb 27, 2015
- Review
- 72 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 4 generations to K031276 (2003). 10 ancestors in all, the oldest K792352 (1979). 7 later devices descend from it, 2 citing it directly.
- 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 deviceK143576 Exactech AmbassadorExactech, Inc. · 2015
- Descendant · cites it directly · 4 of its ownK190227 Boomerang™ Anterior Cervical Plate SystemChoicespine, LP · 2019
- Descendant · 2 generations on · 2 of its ownK243015 Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc. · 2024
- Descendant · 3 generations on · 1 of its ownK250486 Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI) · 2025
- Descendant · cites it directly · 1 of its ownK173867 Axis Anterior Cervical Plate SystemAxis Orthopaedics · 2018
- Descendant · 4 generations on · 0 of its ownK261451 ZSAlign Cervical Interbody SystemZSFab, Inc. · 2026
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K190227Boomerang™ Anterior Cervical Plate SystemChoicespine, LP · 2019 · cites it directly4descendants
- K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc. · 2024 · 2 generations on2descendants
- K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI) · 2025 · 3 generations on1descendant
- K173867Axis Anterior Cervical Plate SystemAxis Orthopaedics · 2018 · cites it directly1descendant
- K261451ZSAlign Cervical Interbody SystemZSFab, Inc. · 2026 · 4 generations on0descendants
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) | K143576 | Exactech Ambassador | Exactech, Inc. | 2015 | — |
| +1 | K190227 | Boomerang™ Anterior Cervical Plate System | Choicespine, LP | 2019 | — |
| +2 | K243015 | Skyway Anterior Cervical Plate System | Kyocera Medical Technologies, Inc. | 2024 | — |
| +3 | K250486 | Skyway Anterior Cervical Plate System | Kyocera Medical Technologies Inc. (KMTI) | 2025 | — |
| +1 | K173867 | Axis Anterior Cervical Plate System | Axis Orthopaedics | 2018 | — |
| +4 | K261451 | ZSAlign Cervical Interbody System | ZSFab, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 2004 | 2 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K071667 | Synthes Vectra-One SystemSummary page 5…Trade or Proprietary or Model Name Manufacturer Predicate Number Type K071667 VECTRA ACP Synthes Primary K042798 C-TEK™ C-Thru Anterior Ce… | 2007 |
| * | K042798 | C-Tek C-Trun Anterior Cervical Plate SystemSummary page 5…Type K071667 VECTRA ACP Synthes Primary K042798 C-TEK™ C-Thru Anterior Cervical Plate Interpore Additional System K070891… | 2004 |
| * | K070891 | Altiva Classic Acp SystemSummary page 5…Synthes Primary K042798 C-TEK™ C-Thru Anterior Cervical Plate Interpore Additional System K070891 Classic ACP System Altiva® Additional PERFORMANCE DATA The Ambassador™ Cervical… | 2007 |
What descends from it? (7)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 21, 2015 | Class II | Z-2071-2015 | Release of Material/Component prior to receiving test results | Shipped to a single consignee prior to completion of final inspection. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 4 companies; a new generation was cleared every 2.7 years on median.
- 2 of the 10 ancestors have a recall of any class.
- Of its descendants, K190227 (Choicespine, LP, 2019) has gone furthest, with 4 descendants of its own.
- 3 other devices also cite its predicate K071667.
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. 2015, 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 Exactech Ambassador™ Cervical Plate System is intended for anterior cervical fixation (C2-T1) for the following indications: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K143576 · printed Nov 4, 2026
Cite this page
510(k) Report. “K143576: Exactech Ambassador.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K143576
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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