510(k) · Cleared
ClearedIN-Tac Bone Anchor System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Influence, Inc. · HXJ Staple Driver
Cleared on Feb 13, 1997 as substantially equivalent to K962372 (Influence, Inc., 1996) after a 70-day review. Its family tree reaches back 2 generations to 1992. 2 later devices descend from it.
- Decided
- Feb 13, 1997
- Review
- 70 days
- Class
- Class I
- Product code
- HXJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K920213 (1992). 3 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK920213 Mitek Anchor, Mitek Anchor IIMitek Surgical Products, Inc. · 1992
- 1 generation backK962372 Urotac Bone Anchor InserterInfluence, Inc. · 1996
- This deviceK964953 IN-Tac Bone Anchor SystemInfluence, Inc. · 1997
- Descendant · cites it directly · 1 of its ownK990160 Microtac-Bone Anchor SystemInfluence, Inc. · 1999
- Descendant · 2 generations on · 0 of its ownK992277 Stapletac Bone Anchor SystemInfluence, Inc. · 1999
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K920213 | Mitek Anchor, Mitek Anchor II | Mitek Surgical Products, Inc. | 1992 | — |
| −1 | K962372 | Urotac Bone Anchor Inserter | Influence, Inc. | 1996 | — |
| 0 (this device) | K964953 | IN-Tac Bone Anchor System | Influence, Inc. | 1997 | — |
| +1 | K990160 | Microtac-Bone Anchor System | Influence, Inc. | 1999 | — |
| +2 | K992277 | Stapletac Bone Anchor System | Influence, Inc. | 1999 | — |
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 |
|---|---|---|
| 1999 | 2 | 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? (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 |
|---|---|---|---|
| * | K962372 | Urotac Bone Anchor InserterSummary page 1…k, President and CEO. This 510(k) notification addresses modifications to the Influence, Inc. UroTac Bone Anchor System, a staple driver (21 CFR 888.4540) cleared under K962372. The modified device will be called the In-Tac Bone Anchor System. The modifications have been implemented to improve convenience… | 1996 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K990160 | Microtac-Bone Anchor System | 1999 | 1 |
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 5 years and passes through 2 companies; a new generation was cleared every 4.3 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K990160 (Influence, Inc., 1999) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K962372.
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 In-Tac Bone Anchor System is indicated for the treatment of stress type (female) urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.
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/K964953 · printed Nov 4, 2026
Cite this page
510(k) Report. “K964953: IN-Tac Bone Anchor System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K964953
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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