510(k) · Cleared
ClearedAbc 2 Screw
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aesculap, Inc. · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on May 4, 2005 as substantially equivalent to K000486 (Aesculap, Inc., 2000) after a 34-day review. Its family tree reaches back 3 generations to 1992. 145 later devices descend from it.
- Decided
- May 4, 2005
- Review
- 34 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K922087 (1992). 11 ancestors in all. 145 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK922087 Anterior Cervical Plate SystemSofamor Danek Mfg., Inc. · 1992
- 2 generations backK990005 Spinal Concepts, Inc. (Sci) Anterior Cervical Plate SystemSpinal Concepts, Inc. · 1999 · Recalled
- 1 generation backK000486 Abc Cervical Plating SystemAesculap, Inc. · 2000
- This deviceK050813 Abc 2 ScrewAesculap, Inc. · 2005
- Descendant · cites it directly · 132 of its ownK133475 Struxxure Anterior Cervical Plate and ScrewsNexxt Spine, LLC · 2013
- Descendant · 2 generations on · 106 of its ownK141376 Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx…Nexxt Spine, LLC · 2014
- Descendant · 3 generations on · 100 of its ownK181435 ATEC Cervical Spacer SystemAlphatec Spine, Inc. · 2018
- Descendant · 4 generations on · 99 of its ownK183705 IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc. · 2019
- Descendant · 5 generations on · 78 of its ownK191311 ATEC Lateral Interbody SystemAlphatec Spine, Inc. · 2019
Showing 5 of 145 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 145 · See all- K133475Struxxure Anterior Cervical Plate and ScrewsNexxt Spine, LLC · 2013 · cites it directly132descendants
- K141376Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx, Struxxure Anterior…Nexxt Spine, LLC · 2014 · 2 generations on106descendants
- K181435ATEC Cervical Spacer SystemAlphatec Spine, Inc. · 2018 · 3 generations on100descendants
- K183705IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc. · 2019 · 4 generations on99descendants
- K191311ATEC Lateral Interbody SystemAlphatec Spine, Inc. · 2019 · 5 generations on78descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K922087 | Anterior Cervical Plate System | Sofamor Danek Mfg., Inc. | 1992 | — |
| −2 | K990005 | Spinal Concepts, Inc. (Sci) Anterior Cervical Plate System | Spinal Concepts, Inc. | 1999 | 1 |
| −1 | K000486 | Abc Cervical Plating System | Aesculap, Inc. | 2000 | — |
| 0 (this device) | K050813 | Abc 2 Screw | Aesculap, Inc. | 2005 | — |
| +1 | K133475 | Struxxure Anterior Cervical Plate and Screws | Nexxt Spine, LLC | 2013 | — |
| +2 | K141376 | Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx, Struxxure… | Nexxt Spine, LLC | 2014 | — |
| +3 | K181435 | ATEC Cervical Spacer System | Alphatec Spine, Inc. | 2018 | — |
| +4 | K183705 | IdentiTi Porous Ti Interbody System | Alphatec Spine, Inc. | 2019 | — |
| +5 | K191311 | ATEC Lateral Interbody System | Alphatec Spine, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1998 | 3 | 0 |
| 1999 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 5 | 0 |
| 2020 | 14 | 0 |
| 2021 | 8 | 0 |
| 2022 | 14 | 0 |
| 2023 | 20 | 0 |
| 2024 | 24 | 0 |
| 2025 | 26 | 0 |
| 2026 | 25 | 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 |
|---|---|---|---|
| * | K000486 | Abc Cervical Plating SystemSummary page 2…ion Screw for the ABC Cervical Plating System (ABC 2 Screw) is substantially equivalent to screws cleared for our current Anterior Cervical Screw Spinal Fixation System (K000486). Plates and Screws for the ABC System were originally cleared in K974706. DEPARTMENT OF HEALTH & HUMAN SERVI… | 2000 |
What descends from it? (145)
See all 1453 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 13 years and passes through 3 companies; a new generation was cleared every 5.1 years on median.
- 1 of the 11 ancestors has a recall of any class.
- Of its descendants, K133475 (Nexxt Spine, LLC, 2013) has gone furthest, with 132 descendants of its own.
- 8 other devices also cite its predicate K000486.
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?
The ABC Cervical Plating System is intended for the treatment of cervical spine instability resulting from degenerative disc disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies), trauma (including fractures), post-traumatic kyphosis or lordosis, tumors, and re-operation for failed previous fusions. Levels of anterior cervical intervertebral body screw fixation for this indication are from C2-T1.
WARNING: This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050813 · printed Nov 4, 2026
Cite this page
510(k) Report. “K050813: Abc 2 Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K050813
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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