510(k) · Cleared
ClearedTitanium Alloy Bone Screws
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aesculap, Inc. · HWC Screw, Fixation, Bone
Cleared on Apr 30, 1997 as substantially equivalent to K930107 (American Medical Electronics, Inc., 1994) and 1 other predicate after a 77-day review. Its family tree reaches back 1 generation to 1991. 26 later devices descend from it.
- Decided
- Apr 30, 1997
- Review
- 77 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K912598 (1991). 2 ancestors in all. 26 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK912598 Ace Cortical Bone ScrewAce Medical Co. · 1991
- This deviceK970549 Titanium Alloy Bone ScrewsAesculap, Inc. · 1997
- Descendant · cites it directly · 20 of its ownK023365 Leforte System Bone ScrewJeil Medical Corporation · 2003
- Descendant · 2 generations on · 9 of its ownK131311 Arix Foot SystemJeil Medical Corporation · 2013
- Descendant · 2 generations on · 8 of its ownK050669 Jeil Bone Fixation SystemJeil Medical Corporation · 2005
- Descendant · 3 generations on · 5 of its ownK161864 ARIX Foot SystemJeil Medical Corporation · 2016
- Descendant · 4 generations on · 4 of its ownK172260 Omni Foot Plating SystemExtremity Medical, LLC · 2017
Showing 5 of 26 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 26 · See all- K023365Leforte System Bone ScrewJeil Medical Corporation · 2003 · cites it directly20descendants
- K131311Arix Foot SystemJeil Medical Corporation · 2013 · 2 generations on9descendants
- K050669Jeil Bone Fixation SystemJeil Medical Corporation · 2005 · 2 generations on8descendants
- K161864ARIX Foot SystemJeil Medical Corporation · 2016 · 3 generations on5descendants
- K172260Omni Foot Plating SystemExtremity Medical, LLC · 2017 · 4 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K912598 | Ace Cortical Bone Screw | Ace Medical Co. | 1991 | — |
| 0 (this device) | K970549 | Titanium Alloy Bone Screws | Aesculap, Inc. | 1997 | — |
| +1 | K023365 | Leforte System Bone Screw | Jeil Medical Corporation | 2003 | — |
| +2 | K131311 | Arix Foot System | Jeil Medical Corporation | 2013 | — |
| +2 | K050669 | Jeil Bone Fixation System | Jeil Medical Corporation | 2005 | — |
| +3 | K161864 | ARIX Foot System | Jeil Medical Corporation | 2016 | — |
| +4 | K172260 | Omni Foot Plating System | Extremity Medical, LLC | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2019 | 5 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2025 | 2 | 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 |
|---|---|---|---|
| * | K930107 | Ame Universal Bone ScrewSummary page 2…n, function, and intended use to Aesculap’s current line of bone screws and other existing legally marketed bone screws such as: - AME Universal bone screw (subject to #K930107) and - Ace Cortical bone screw (subject to #K912598). 1000 GATEWAY BOULEVARD - SOUTH SAN FRANCISCO, CA 94080-7030 - USA - 415-8… | 1994 |
| * | K912598 | Ace Cortical Bone ScrewSummary page 2…ine of bone screws and other existing legally marketed bone screws such as: - AME Universal bone screw (subject to #K930107) and - Ace Cortical bone screw (subject to #K912598). 1000 GATEWAY BOULEVARD - SOUTH SAN FRANCISCO, CA 94080-7030 - USA - 415-876-7000 - FAX: 415-876-7028~. - Ons | 1991 |
| * | — | Aesculap’s current line of bone screws Named without a submission number |
What descends from it? (26)
See all 263 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?
- None of the 2 ancestors has a recall.
- Of its descendants, K023365 (Jeil Medical Corporation, 2003) has gone furthest, with 20 descendants of its own.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
The titanium alloy cortical bone screws presented in this submission are intended for long and small bone fracture fixation.
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/K970549 · printed Nov 4, 2026
Cite this page
510(k) Report. “K970549: Titanium Alloy Bone Screws.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K970549
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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