510(k) · Cleared
ClearedUrotac Bone Anchor Inserter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Influence, Inc. · HXJ Staple Driver
Cleared on Aug 19, 1996 as substantially equivalent to K920213 (Mitek Surgical Products, Inc., 1992) and 1 other predicate after a 61-day review. Its family tree reaches back 1 generation to 1992. 44 later devices descend from it.
- Decided
- Aug 19, 1996
- Review
- 61 days
- Class
- Class I
- Product code
- HXJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K920213 (1992). 2 ancestors in all. 44 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK920213 Mitek Anchor, Mitek Anchor IIMitek Surgical Products, Inc. · 1992
- This deviceK962372 Urotac Bone Anchor InserterInfluence, Inc. · 1996
- Descendant · cites it directly · 40 of its ownK970292 IN-Fast Bone Screw System/in-Fast Bone Screw Inserter/in-Fast Bone…Influence, Inc. · 1997 · Recalled
- Descendant · 2 generations on · 23 of its ownK972023 Sleep-in Bone Screw SystemInfluence, Inc. · 1997
- Descendant · 2 generations on · 16 of its ownK981677 Repose Bone Screw SystemInfluence, Inc. · 1999 · Recalled
- Descendant · 3 generations on · 15 of its ownK101060 Siesta Medical, Inc., Prelude Tongue Suspension SystemSiesta Medical, Inc. · 2010
- Descendant · 4 generations on · 14 of its ownK103179 Prelude II Tounge Suspension SystemSiesta Medical, Inc. · 2010
Showing 5 of 44 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 44 · See all- K970292IN-Fast Bone Screw System/in-Fast Bone Screw Inserter/in-Fast Bone ScrewInfluence, Inc. · 1997 · cites it directly40descendants
- K972023Sleep-in Bone Screw SystemInfluence, Inc. · 1997 · 2 generations on23descendants
- K981677Repose Bone Screw SystemInfluence, Inc. · 1999 · 2 generations on16descendants
- K101060Siesta Medical, Inc., Prelude Tongue Suspension SystemSiesta Medical, Inc. · 2010 · 3 generations on15descendants
- K103179Prelude II Tounge Suspension SystemSiesta Medical, Inc. · 2010 · 4 generations on14descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K920213 | Mitek Anchor, Mitek Anchor II | Mitek Surgical Products, Inc. | 1992 | — |
| 0 (this device) | K962372 | Urotac Bone Anchor Inserter | Influence, Inc. | 1996 | — |
| +1 | K970292 | IN-Fast Bone Screw System/in-Fast Bone Screw Inserter/in-Fast Bone Screw | Influence, Inc. | 1997 | 1 |
| +2 | K972023 | Sleep-in Bone Screw System | Influence, Inc. | 1997 | — |
| +2 | K981677 | Repose Bone Screw System | Influence, Inc. | 1999 | 2 |
| +3 | K101060 | Siesta Medical, Inc., Prelude Tongue Suspension System | Siesta Medical, Inc. | 2010 | — |
| +4 | K103179 | Prelude II Tounge Suspension System | Siesta Medical, Inc. | 2010 | — |
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 |
|---|---|---|
| 1997 | 4 | 0 |
| 1998 | 1 | 0 |
| 1999 | 4 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2004 | 1 | 0 |
| 2006 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 3 | 0 |
| 2011 | 3 | 0 |
| 2012 | 6 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 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 HXJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K920213 | Mitek Anchor, Mitek Anchor IISummary page 1…strument used to insert bone anchor in desired situs. CLASSIFICATION NAME Surgical Instrument - Staple Driver PREDICATE DEVICE MITEK GII Bone Anchor (and accessories) (K920213) MICROVASIVE (VESICA) Bone Anchor (K932925) DESCRIPTION OF THE DEVICE FUNCTION Fixation of non-absorbable suture below bone su… | 1992 |
| * | K932925 | Bone Anchor for Soft Tissue AttachmentSummary page 1…red situs. CLASSIFICATION NAME Surgical Instrument - Staple Driver PREDICATE DEVICE MITEK GII Bone Anchor (and accessories) (K920213) MICROVASIVE (VESICA) Bone Anchor (K932925) DESCRIPTION OF THE DEVICE FUNCTION Fixation of non-absorbable suture below bone surface for soft tissue fixation. UroTac Bon… | 1994 |
What descends from it? (44)
See all 442 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?
How does its category compare?
All HXJ devicesHXJ Staple Driver: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HXJ
FDA has decided no HXJ device since 2007.
Median 510(k) review, days · HXJ
Too few HXJ 510(k)s in any year since 2007 to give a median.
Recalls per year · HXJ
No recall names HXJ since 2007.
Adverse event reports per year · HXJ
1in 2009
MAUDE reports naming product code HXJ, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The UroTac Bone Anchor System is intended for soft tissue fixation to the pubic bone by means of bone anchors threaded with suture. The UroTac Bone Anchor System is indicated for the treatment of stress type (female) urinary incontinence resulting from urethral hypermobility.
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/K962372 · printed Nov 6, 2026
Cite this page
510(k) Report. “K962372: Urotac Bone Anchor Inserter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K962372
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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