510(k) · Cleared
Recalled · 2009Next Generation Anterior Cervical Plating System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alphatec Spine, Inc. · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on May 4, 2007 as substantially equivalent to K000536 (Synthes Spine, 2000) and 1 other predicate after a 53-day review. Its family tree reaches back 3 generations to 1997. 62 later devices descend from it. It has been recalled once.
- Decided
- May 4, 2007
- Review
- 53 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 3 generations to K971730 (1997). 5 ancestors in all. 62 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK971730 Depuy Motech Peak Polyaxial Anterior Cervical Plate SystemDepuy, Inc. · 1997
- 2 generations backK013439 Anterior Cervical Plate SystemScien'Tx USA, Inc. · 2002
- 1 generation backK042317 Cervical PlateScient'X · 2004
- This deviceK070681 Next Generation Anterior Cervical Plating SystemAlphatec Spine, Inc. · 2007
- Descendant · cites it directly · 38 of its ownK102820 Appliance, Fixation, Spinal Intervertebral BodyAlphatec Spine, Inc. · 2010 · Recalled
- Descendant · cites it directly · 26 of its ownK112533 Zavation Cervical Plate SystemZavation, LLC · 2011
- Descendant · 2 generations on · 18 of its ownK163104 Terrace™ Anterior Cervical Plate SystemCorelink, LLC · 2017
- Descendant · 3 generations on · 15 of its ownK190016 Lateral Plate SystemCorelink, LLC · 2019
- Descendant · 2 generations on · 15 of its ownK130030 Zavation Cervical Plate SystemZavation, LLC · 2013
Showing 5 of 62 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 62 · See all- K102820Appliance, Fixation, Spinal Intervertebral BodyAlphatec Spine, Inc. · 2010 · cites it directly38descendants
- K112533Zavation Cervical Plate SystemZavation, LLC · 2011 · cites it directly26descendants
- K163104Terrace™ Anterior Cervical Plate SystemCorelink, LLC · 2017 · 2 generations on18descendants
- K190016Lateral Plate SystemCorelink, LLC · 2019 · 3 generations on15descendants
- K130030Zavation Cervical Plate SystemZavation, LLC · 2013 · 2 generations on15descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K971730 | Depuy Motech Peak Polyaxial Anterior Cervical Plate System | Depuy, Inc. | 1997 | — |
| −2 | K013439 | Anterior Cervical Plate System | Scien'Tx USA, Inc. | 2002 | — |
| −1 | K042317 | Cervical Plate | Scient'X | 2004 | — |
| 0 (this device) | K070681 | Next Generation Anterior Cervical Plating System | Alphatec Spine, Inc. | 2007 | — |
| +1 | K102820 | Appliance, Fixation, Spinal Intervertebral Body | Alphatec Spine, Inc. | 2010 | 2 |
| +1 | K112533 | Zavation Cervical Plate System | Zavation, LLC | 2011 | — |
| +2 | K163104 | Terrace™ Anterior Cervical Plate System | Corelink, LLC | 2017 | — |
| +3 | K190016 | Lateral Plate System | Corelink, LLC | 2019 | — |
| +2 | K130030 | Zavation Cervical Plate System | Zavation, LLC | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 3 | 0 |
| 2017 | 3 | 0 |
| 2018 | 5 | 0 |
| 2019 | 2 | 0 |
| 2020 | 6 | 0 |
| 2021 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 8 | 0 |
| 2024 | 9 | 0 |
| 2025 | 10 | 0 |
| 2026 | 4 | 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? (2)
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 |
|---|---|---|---|
| * | K000536 | Synthes Anterior CSLP SystemSummary page 2…the following predicate devices: Trade/Proprietary Name Manufacturer Clearance CSLP Synthes Spine K000536 Stella Scient'x K042317 Performance Data: Mechanical and dynamic testing of the… | 2000 |
| * | K042317 | Cervical PlateSummary page 2…nufacturer Clearance CSLP Synthes Spine K000536 Stella Scient'x K042317 Performance Data: Mechanical and dynamic testing of the cervical plate system was performed. The test results demonstrate that… | 2004 |
What descends from it? (62)
See all 622 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 |
|---|---|---|---|---|
| Aug 25, 2009 | Not classified | Z-1746-2010 | Labeling mix-ups | The recall was initiated after the firm discovered that the affected lot was labeled incorrectly in that the packaging label indicates that the part number of the lot is 61002-026, which corresponds to a two-level Trestle Anterior… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 10 years and passes through 4 companies; a new generation was cleared every 2.7 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K102820 (Alphatec Spine, Inc., 2010) has gone furthest, with 38 descendants of its own.
- 39 other devices also cite its predicate K000536.
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. 2007, 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?
It is intended that this device, in any system configuration, be removed after the development of solid fusion mass of spinal segments in skeletally mature patients. The NEXT GENERATIONTM Anterior Cervical Plate system is intended for use in anterior cervical decompression and fusion (ACDF) surgery (C2-C7). The system is indicated for use in the temporary stabilization of the anterior spine during the development of fusion in patients with the following…
Read the full statement (113 words)
It is intended that this device, in any system configuration, be removed after the development of solid fusion mass of spinal segments in skeletally mature patients.
The NEXT GENERATIONTM Anterior Cervical Plate system is intended for use in anterior cervical decompression and fusion (ACDF) surgery (C2-C7). The system is indicated for use in the temporary stabilization of the anterior spine during the development of fusion in patients with the following conditions:
• degenerative disc disease(DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)
· spondylolisthesis
* trauma (i.e., fracture or dislocation)
· spinal stenosis
* pseudoarthrosis
* tumor
* and failed previous fusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070681 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070681: Next Generation Anterior Cervical Plating System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070681
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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