510(k) · Cleared
ClearedAuxilock Titanium Interference Screw
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Auxein Medical Private Limited · HWC Screw, Fixation, Bone
Cleared on Aug 20, 2021 as substantially equivalent to K083619 (Parcus Medical, LLC, 2009) after a 322-day review. Its family tree reaches back 5 generations to 1993.
- Decided
- Aug 20, 2021
- Review
- 322 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K915424 (1993). 15 ancestors in all, the oldest K895711 (1990). No later device cites it as a predicate yet.
- Root · 5 generations backK915424 Arthrex Cannulated Interference ScrewArthrex, Inc. · 1993
- 4 generations backK980841 Rci Fixation ScrewsSmith & Nephew, Inc. · 1998
- 3 generations backK992396 Biorci ScrewSmith & Nephew Endoscopy, Inc. · 2000
- 2 generations backK032224 Biorci ScrewSmith & Nephew, Inc. · 2003
- 1 generation backK083619 Parcus Tintanium Interference Screw, Models: 10001-10012…Parcus Medical, LLC · 2009
- This deviceK203029 Auxilock Titanium Interference ScrewAuxein Medical Private Limited · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K915424 | Arthrex Cannulated Interference Screw | Arthrex, Inc. | 1993 | — |
| −4 | K980841 | Rci Fixation Screws | Smith & Nephew, Inc. | 1998 | — |
| −3 | K992396 | Biorci Screw | Smith & Nephew Endoscopy, Inc. | 2000 | — |
| −2 | K032224 | Biorci Screw | Smith & Nephew, Inc. | 2003 | — |
| −1 | K083619 | Parcus Tintanium Interference Screw, Models: 10001-10012, 10014-10016… | Parcus Medical, LLC | 2009 | — |
| 0 (this device) | K203029 | Auxilock Titanium Interference Screw | Auxein Medical Private Limited | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 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? (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 |
|---|---|---|---|
| * | K083619 | Parcus Tintanium Interference Screw, Models: 10001-10012, 10014-10016, 10018-10020Summary page 5…r corresponding predicate devices. S.No. Item Description Predicate Device 1. Auxilock Titanium Interference Screw K083619, Parcus Titanium Interference Screw Reference Device: K201457, Auxien Brand… | 2009 |
| † | K201457 | Auxein Brand Vertaux 5.5 mm Pedicle Screw System | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
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 28 years and passes through 5 companies; a new generation was cleared every 5.3 years on median.
- 1 of the 15 ancestors has a recall of any class.
- 2 other devices also cite its predicate K083619.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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?
The Auxilock Titanium Interference Screw is indicated for use in the fixation of ligaments and tendons in patients requiring ligament or tendon repair.
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/K203029 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203029: Auxilock Titanium Interference Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203029
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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