510(k) · Cleared
ClearedStraight-in Bone Screw Fixation 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 Oct 9, 1997 as substantially equivalent to K970292 (Influence, Inc., 1997) and 1 other predicate after an 87-day review. Its family tree reaches back 3 generations to 1992. 14 later devices descend from it.
- Decided
- Oct 9, 1997
- Review
- 87 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K920213 (1992). 6 ancestors in all. 14 later devices descend from it, 2 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 backK970292 IN-Fast Bone Screw System/in-Fast Bone Screw Inserter/in-Fast Bone…Influence, Inc. · 1997 · Recalled
- This deviceK972622 Straight-in Bone Screw Fixation SystemInfluence, Inc. · 1997
- Descendant · cites it directly · 12 of its ownK982155 Short Straight-in Bone Screw Fixation SystemInfluence, Inc. · 1998
- Descendant · 2 generations on · 10 of its ownK053371 Ams Male Transobturator Sling SystemAmerican Medical Systems, Inc. · 2006 · Recalled
- Descendant · 3 generations on · 5 of its ownK082640 Virtue Ventral Urethral Elevation Sling SystemColoplast Manufacturing Us, LLC · 2008
- Descendant · 4 generations on · 4 of its ownK091152 Virtue Ventral Urethral Elevation Sling System, Model 50020Coloplast A/S · 2009
- Descendant · 4 generations on · 3 of its ownK101297 Virtue Ventral Urethral Elevation Sling System Model 50020Coloplast A/S · 2010
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K982155Short Straight-in Bone Screw Fixation SystemInfluence, Inc. · 1998 · cites it directly12descendants
- K053371Ams Male Transobturator Sling SystemAmerican Medical Systems, Inc. · 2006 · 2 generations on10descendants
- K082640Virtue Ventral Urethral Elevation Sling SystemColoplast Manufacturing Us, LLC · 2008 · 3 generations on5descendants
- K091152Virtue Ventral Urethral Elevation Sling System, Model 50020Coloplast A/S · 2009 · 4 generations on4descendants
- K101297Virtue Ventral Urethral Elevation Sling System Model 50020Coloplast A/S · 2010 · 4 generations on3descendants
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 | K970292 | IN-Fast Bone Screw System/in-Fast Bone Screw Inserter/in-Fast Bone Screw | Influence, Inc. | 1997 | 1 |
| 0 (this device) | K972622 | Straight-in Bone Screw Fixation System | Influence, Inc. | 1997 | — |
| +1 | K982155 | Short Straight-in Bone Screw Fixation System | Influence, Inc. | 1998 | — |
| +2 | K053371 | Ams Male Transobturator Sling System | American Medical Systems, Inc. | 2006 | 3 |
| +3 | K082640 | Virtue Ventral Urethral Elevation Sling System | Coloplast Manufacturing Us, LLC | 2008 | — |
| +4 | K091152 | Virtue Ventral Urethral Elevation Sling System, Model 50020 | Coloplast A/S | 2009 | — |
| +4 | K101297 | Virtue Ventral Urethral Elevation Sling System Model 50020 | Coloplast A/S | 2010 | — |
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 |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2006 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 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? (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 |
|---|---|---|---|
| * | K970292 | IN-Fast Bone Screw System/in-Fast Bone Screw Inserter/in-Fast Bone ScrewSummary page 1…/or intrinsic sphincter deficiency). The Straight-In Bone Screw Fixation System is substantially equivalent to Influence, Inc.’s In-Fast Bone Screw System cleared under K970292 and the Vesica Suture Anchor System cleared under K932925. The mechanical properties and device materials of the Straight-In and… | 1997 |
| * | K932925 | Bone Anchor for Soft Tissue AttachmentSummary page 1…Screw Fixation System is substantially equivalent to Influence, Inc.’s In-Fast Bone Screw System cleared under K970292 and the Vesica Suture Anchor System cleared under K932925. The mechanical properties and device materials of the Straight-In and In-Fast systems are identical. In both devices, fixation o… | 1994 |
What descends from it? (14)
See all 142 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?
- The line of descent spans 5 years and passes through 2 companies; a new generation was cleared every 8 months on median.
- 2 of the 6 ancestors have a recall of any class.
- Of its descendants, K982155 (Influence, Inc., 1998) has gone furthest, with 12 descendants of its own.
- 3 other devices also cite its predicate K970292.
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 Straight-In Bone Screw Fixation System is intended for soft tissue fixation to the pubic bone by means of bone screws threaded with suture. It is indicated for use during open or laparoscopic surgical procedures where soft tissue fixation to the pubic bone is needed (e.g., bladder neck suspension and urethral sling procedures for female stress 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/K972622 · printed Nov 4, 2026
Cite this page
510(k) Report. “K972622: Straight-in Bone Screw Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K972622
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