510(k) · Cleared
Recalled · 2008IN-Fast Bone Screw System/in-Fast Bone Screw Inserter/in-Fast Bone Screw
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 Apr 23, 1997 as substantially equivalent to K962372 (Influence, Inc., 1996) and 4 other predicates after an 89-day review. Its family tree reaches back 2 generations to 1992. 40 later devices descend from it. It has been recalled once.
- Decided
- Apr 23, 1997
- Review
- 89 days
- Class
- Class II
- Product code
- MBI
- Recalls
- 1
- Predicates
- 5
Its longest line of descent runs back 2 generations to K920213 (1992). 5 ancestors in all. 40 later devices descend from it, 4 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 deviceK970292 IN-Fast Bone Screw System/in-Fast Bone Screw Inserter/in-Fast Bone…Influence, Inc. · 1997
- Descendant · cites it directly · 23 of its ownK972023 Sleep-in Bone Screw SystemInfluence, Inc. · 1997
- Descendant · cites it directly · 16 of its ownK981677 Repose Bone Screw SystemInfluence, Inc. · 1999 · Recalled
- Descendant · 2 generations on · 15 of its ownK101060 Siesta Medical, Inc., Prelude Tongue Suspension SystemSiesta Medical, Inc. · 2010
- Descendant · 3 generations on · 14 of its ownK103179 Prelude II Tounge Suspension SystemSiesta Medical, Inc. · 2010
- Descendant · cites it directly · 14 of its ownK972622 Straight-in Bone Screw Fixation SystemInfluence, Inc. · 1997
Showing 5 of 40 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 40 · See all- K972023Sleep-in Bone Screw SystemInfluence, Inc. · 1997 · cites it directly23descendants
- K981677Repose Bone Screw SystemInfluence, Inc. · 1999 · cites it directly16descendants
- K101060Siesta Medical, Inc., Prelude Tongue Suspension SystemSiesta Medical, Inc. · 2010 · 2 generations on15descendants
- K103179Prelude II Tounge Suspension SystemSiesta Medical, Inc. · 2010 · 3 generations on14descendants
- K972622Straight-in Bone Screw Fixation SystemInfluence, Inc. · 1997 · cites it directly14descendants
View 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) | K970292 | IN-Fast Bone Screw System/in-Fast Bone Screw Inserter/in-Fast Bone Screw | Influence, Inc. | 1997 | — |
| +1 | K972023 | Sleep-in Bone Screw System | Influence, Inc. | 1997 | — |
| +1 | K981677 | Repose Bone Screw System | Influence, Inc. | 1999 | 2 |
| +2 | K101060 | Siesta Medical, Inc., Prelude Tongue Suspension System | Siesta Medical, Inc. | 2010 | — |
| +3 | K103179 | Prelude II Tounge Suspension System | Siesta Medical, Inc. | 2010 | — |
| +1 | K972622 | Straight-in Bone Screw Fixation System | Influence, Inc. | 1997 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 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 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? (5)
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…rmobility and/or intrinsic sphincter deficiency. The /n-Fast Bone Anchor System is substantially equivalent to Influence, Inc.’s UroTac Bone Screw System cleared under K962372. The mechanical properties and technical procedure of the two systems are almost identical. In both devices, fixation of soft tis… | 1996 |
| * | K932925 | Bone Anchor for Soft Tissue AttachmentSummary page 1…g procedure may be performed using the /n-Fast which is substantially equivalent to the in situ sling technique used in conjunction with the Vesica Suture Anchor System (K932925, Boston Scientific Corp., by its Microvasive division, the successor-in-interest to Vesica Medical, Inc., formerly Vesitec). Th… | 1994 |
| * | K920213 | Mitek Anchor, Mitek Anchor IISummary page 1…chor System (K932925, Boston Scientific Corp., by its Microvasive division, the successor-in-interest to Vesica Medical, Inc., formerly Vesitec). The Mitek GII Anchor (K920213), used in bladder neck suspensions, and the /n-Fast bone screw have been proven to provide substantially equivalent fixation stre… | 1992 |
| * | K953264 | Questus Polyester Suture Soft Tissue Anchor SystemSummary page 1…r neck suspensions, and the /n-Fast bone screw have been proven to provide substantially equivalent fixation strength. The QuestusTM Polyester Soft Tissue Anchor System (K953264 and K963200, Wright Medical Technologies, Inc.) is also used in bladder neck suspensions and closely resembles the screw used in… | 1995 |
| * | K963200 | Questus Polyester Suture Soft Tissue Anchor SystemSummary page 1…nsions, and the /n-Fast bone screw have been proven to provide substantially equivalent fixation strength. The QuestusTM Polyester Soft Tissue Anchor System (K953264 and K963200, Wright Medical Technologies, Inc.) is also used in bladder neck suspensions and closely resembles the screw used in the /n-Fast… | 1996 |
What descends from it? (40)
See all 404 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 28, 2008 | Not classified | Z-1235-2008 | Process control | Missing part: The units in two lots of In-Fast Ultra Transvaginal Bladder Neck Support System may contain only one bone screw, but should contain two as indicated on the labeling. Two screws are required to complete the procedure. The… |
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 5 ancestors has a recall of any class.
- Of its descendants, K972023 (Influence, Inc., 1997) has gone furthest, with 23 descendants of its own.
- 1 other device also cites its predicate K962372.
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 In-Fast Bone Screw 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/K970292 · printed Nov 4, 2026
Cite this page
510(k) Report. “K970292: IN-Fast Bone Screw System/in-Fast Bone Screw Inserter/in-Fast Bone Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K970292
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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