510(k) · Cleared
ClearedAIS Odontoid Fracture Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aesculap Implant System, Inc. · HWC Screw, Fixation, Bone
Cleared on Dec 19, 2014 as substantially equivalent to K970549 (Aesculap, Inc., 1997) and 2 other predicates after an 88-day review. Its family tree reaches back 3 generations to 1979. 3 later devices descend from it.
- Decided
- Dec 19, 2014
- Review
- 88 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K792022 (1979). 10 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK792022 Herbert Bone ScrewZimmer, Inc. · 1979 · Recalled
- 2 generations backK020791 HBS Headless Bone ScrewMillennium Medical Technologies, Inc. · 2002
- 1 generation backK132910 Depuy Synthes Spine Dens Access SystemSynthes USA Products, LLC · 2013
- This deviceK142707 AIS Odontoid Fracture Fixation SystemAesculap Implant System, Inc. · 2014
- Descendant · cites it directly · 2 of its ownK192744 CORRIDOR Fixation SystemGlobus Medical, Inc. · 2019
- Descendant · 2 generations on · 1 of its ownK250920 Arthrex Spine Compression FT ScrewArthrex, Inc. · 2025
- Descendant · 3 generations on · 0 of its ownK262618 Arthrex Spine Compression FT ScrewArthrex, Inc. · 2026
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K792022 | Herbert Bone Screw | Zimmer, Inc. | 1979 | 6 |
| −2 | K020791 | HBS Headless Bone Screw | Millennium Medical Technologies, Inc. | 2002 | — |
| −1 | K132910 | Depuy Synthes Spine Dens Access System | Synthes USA Products, LLC | 2013 | — |
| 0 (this device) | K142707 | AIS Odontoid Fracture Fixation System | Aesculap Implant System, Inc. | 2014 | — |
| +1 | K192744 | CORRIDOR Fixation System | Globus Medical, Inc. | 2019 | — |
| +2 | K250920 | Arthrex Spine Compression FT Screw | Arthrex, Inc. | 2025 | — |
| +3 | K262618 | Arthrex Spine Compression FT Screw | Arthrex, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1994 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2003 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 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 HWC? 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 HWC device
- #1 K203011 Monster Screw Systemscore 22.2 · 14 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 |
|---|---|---|---|
| * | K970549 | Titanium Alloy Bone ScrewsSummary page 4…Class II PURPOSE FOR PREMARKET NOTIFICATION The submission expands the indications for use of the Aesculap Titanium Alloy Bone Screws cleared under K970549. DEVICE DESCRIPTION The AIS Odontoid Fracture Fracture Fixation System is comprised of screws and instruments. The 4.0mm cortica… | 1997 |
| * | K020791 | HBS Headless Bone ScrewSummary page 5…erefore found to be substantially equivalent. PREDICATE DEVICE • Aesculap Titanium Alloy Bone Screws (K970549) • BioPro (Millenium Medical) HBS Headless Bone Screw (K020791) • DePuy Synthes Spine Dens Access System (K132910) | 2002 |
| * | K132910 | Depuy Synthes Spine Dens Access SystemSummary page 5…ATE DEVICE • Aesculap Titanium Alloy Bone Screws (K970549) • BioPro (Millenium Medical) HBS Headless Bone Screw (K020791) • DePuy Synthes Spine Dens Access System (K132910) | 2013 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K192744 | CORRIDOR Fixation System | 2019 | 2 |
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 35 years and passes through 4 companies; a new generation was cleared every 11.5 years on median.
- 1 of the 10 ancestors has a recall of any class.
- Of its descendants, K192744 (Globus Medical, Inc., 2019) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K970549.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · HWC
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HWC
111in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HWC
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HWC
2,893in 2025
MAUDE reports naming product code HWC, 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 | 35 | 77 | 25 | 669 |
| 2008 | 33 | 76 | 33 | 660 |
| 2009 | 27 | 113 | 29 | 651 |
| 2010 | 23 | 110 | 7 | 765 |
| 2011 | 35 | 88 | 12 | 1,104 |
| 2012 | 20 | 99 | 30 | 3,339 |
| 2013 | 25 | 90 | 14 | 3,850 |
| 2014 | 31 | 88 | 2 | 2,549 |
| 2015 | 41 | 85 | 5 | 2,711 |
| 2016 | 26 | 131 | 4 | 2,285 |
| 2017 | 40 | 127 | 4 | 2,561 |
| 2018 | 20 | 106 | 1 | 3,662 |
| 2019 | 30 | 108 | 5 | 5,463 |
| 2020 | 28 | 75 | 4 | 4,820 |
| 2021 | 26 | 84 | 2 | 4,446 |
| 2022 | 26 | 167 | 13 | 3,934 |
| 2023 | 24 | 104 | 0 | 3,718 |
| 2024 | 17 | 90 | 0 | 3,575 |
| 2025 | 15 | 111 | 1 | 2,893 |
| 2026 | 21 | 125 | 2 | — |
What is it indicated for?
For fracture fixation of small bones and small bone fragments including odontoid fractures.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K142707 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142707: AIS Odontoid Fracture 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/K142707
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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