510(k) · Cleared
ClearedMicrotac-Bone Anchor System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Influence, Inc. · MBI Fastener, Fixation, Nondegradable, Soft Tissue
Cleared on Feb 16, 1999 as substantially equivalent to K964953 (Influence, Inc., 1997) after a 28-day review. Its family tree reaches back 3 generations to 1992. 1 later device descends from it.
- Decided
- Feb 16, 1999
- Review
- 28 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K920213 (1992). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK920213 Mitek Anchor, Mitek Anchor IIMitek Surgical Products, Inc. · 1992
- 2 generations backK962372 Urotac Bone Anchor InserterInfluence, Inc. · 1996
- 1 generation backK964953 IN-Tac Bone Anchor SystemInfluence, Inc. · 1997
- This deviceK990160 Microtac-Bone Anchor SystemInfluence, Inc. · 1999
- Descendant · cites it directly · 0 of its ownK992277 Stapletac Bone Anchor SystemInfluence, Inc. · 1999
Most influential descendants
Showing 1 of 1 · See all- K992277Stapletac Bone Anchor SystemInfluence, Inc. · 1999 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K920213 | Mitek Anchor, Mitek Anchor II | Mitek Surgical Products, Inc. | 1992 | — |
| −2 | K962372 | Urotac Bone Anchor Inserter | Influence, Inc. | 1996 | — |
| −1 | K964953 | IN-Tac Bone Anchor System | Influence, Inc. | 1997 | — |
| 0 (this device) | K990160 | Microtac-Bone Anchor System | Influence, Inc. | 1999 | — |
| +1 | 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 | 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 MBI? 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 MBI device
- #1 K203268 Arthrex FiberTak Suture Anchorscore 21.4 · 11 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 |
|---|---|---|---|
| * | K964953 | IN-Tac Bone Anchor SystemSummary page 1…mobility and/or intrinsic sphincter deficiency. The MicroTac Bone Anchor System is substantially equivalent to Influence, Inc.’s In-Tac Bone Anchor System cleared under K964953 with respect to intended use, materials and performance of the bone anchors. The major differences between the two systems are th… | 1997 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K992277 | Stapletac Bone Anchor System | 1999 | 0 |
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 7 years and passes through 2 companies; a new generation was cleared every 2.0 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K992277 (Influence, Inc., 1999) has gone furthest, with 0 descendants of its own.
How does its category compare?
All MBI devicesMBI Fastener, Fixation, Nondegradable, Soft Tissue: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MBI
27in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MBI
58in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MBI
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MBI
3,826in 2025
MAUDE reports naming product code MBI, 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 | 16 | 80 | 24 | 240 |
| 2008 | 10 | 69 | 6 | 338 |
| 2009 | 19 | 82 | 2 | 355 |
| 2010 | 17 | 76 | 3 | 291 |
| 2011 | 30 | 75 | 23 | 328 |
| 2012 | 24 | 94 | 6 | 371 |
| 2013 | 31 | 100 | 2 | 442 |
| 2014 | 23 | 101 | 0 | 504 |
| 2015 | 23 | 85 | 0 | 507 |
| 2016 | 17 | 94 | 0 | 795 |
| 2017 | 17 | 70 | 4 | 675 |
| 2018 | 16 | 91 | 2 | 1,072 |
| 2019 | 31 | 90 | 0 | 1,303 |
| 2020 | 35 | 83 | 1 | 1,454 |
| 2021 | 18 | 107 | 0 | 1,890 |
| 2022 | 19 | 64 | 0 | 1,591 |
| 2023 | 52 | 57 | 1 | 2,503 |
| 2024 | 22 | 30 | 1 | 3,779 |
| 2025 | 27 | 58 | 1 | 3,826 |
| 2026 | 30 | 63 | 0 | — |
What is it indicated for?
The MicroTac Bone Anchor System is intended for soft tissue fixation to the pubic bone by means of bone anchors threaded with sutures. It is indicated for cystourethropexy and vaginal sling procedures 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/K990160 · printed Nov 4, 2026
Cite this page
510(k) Report. “K990160: Microtac-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/K990160
Report an extraction error
Are you the manufacturer?
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