510(k) · Cleared
ClearedDepuy Synthes Spine Dens Access System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes USA Products, LLC · HWC Screw, Fixation, Bone
Cleared on Dec 16, 2013 as substantially equivalent to K963192 (Synthes (Usa), 1996) and 2 other predicates after a 90-day review. Its family tree reaches back 2 generations to 1979. 4 later devices descend from it.
- Decided
- Dec 16, 2013
- Review
- 90 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K792022 (1979). 6 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK792022 Herbert Bone ScrewZimmer, Inc. · 1979 · Recalled
- 1 generation backK020791 HBS Headless Bone ScrewMillennium Medical Technologies, Inc. · 2002
- This deviceK132910 Depuy Synthes Spine Dens Access SystemSynthes USA Products, LLC · 2013
- Descendant · cites it directly · 3 of its ownK142707 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 4 of 4 · See all- K142707AIS Odontoid Fracture Fixation SystemAesculap Implant System, Inc. · 2014 · cites it directly3descendants
- K192744CORRIDOR Fixation SystemGlobus Medical, Inc. · 2019 · cites it directly2descendants
- K250920Arthrex Spine Compression FT ScrewArthrex, Inc. · 2025 · 2 generations on1descendant
- K262618Arthrex Spine Compression FT ScrewArthrex, Inc. · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K792022 | Herbert Bone Screw | Zimmer, Inc. | 1979 | 6 |
| −1 | K020791 | HBS Headless Bone Screw | Millennium Medical Technologies, Inc. | 2002 | — |
| 0 (this device) | K132910 | Depuy Synthes Spine Dens Access System | Synthes USA Products, LLC | 2013 | — |
| +1 | 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 |
|---|---|---|
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 2003 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K963192 | Synthes Sterile 3.5 MM and 4.0 MM Cannulated ScrewsSummary page 1…assification Name: Smooth or Threaded Metallic Bone Fixation Fastener Regulation Number: 21 CFR 888.3040 Predicate Devices: Synthes 4.0mim Cannulated Screw - K963 192 HBS Headless Bone Screw - K020791I Headless Compression Screw - KI 12672 Device De… | 1996 |
| * | K020791 | HBS Headless Bone ScrewSummary page 1…tion Fastener Regulation Number: 21 CFR 888.3040 Predicate Devices: Synthes 4.0mim Cannulated Screw - K963 192 HBS Headless Bone Screw - K020791I Headless Compression Screw - KI 12672 Device Description: DePUY Synthes Spine Dens Access System is c… | 2002 |
| * | K112672 | Headless Compression Screw | 2011 |
What descends from it? (4)
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 34 years and passes through 3 companies; a new generation was cleared every 22.6 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K142707 (Aesculap Implant System, Inc., 2014) has gone furthest, with 3 descendants of its own.
- 22 other devices also cite its predicate K963192.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 as stated in the FDA summary.
https://510kreport.com/device/K132910 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132910: Depuy Synthes Spine Dens Access System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132910
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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