510(k) · Cleared
ClearedInnovasive 2.8MM Roc Suture Bone Fastener and 3.5MM Roc Suture Bone Fastener
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Innovasive Devices, Inc. · MBI Fastener, Fixation, Nondegradable, Soft Tissue
Cleared on Nov 4, 1996 after a 67-day review. The FDA summary names its predicate without a number. 18 later devices descend from it.
- Decided
- Nov 4, 1996
- Review
- 67 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 0
18 later devices descend from it, 4 citing it directly.
- This deviceK963402 Innovasive 2.8MM Roc Suture Bone Fastener and 3.5MM Roc Suture Bone…Innovasive Devices, Inc. · 1996
- Descendant · cites it directly · 10 of its ownK060970 Axyaloop Nonabsorbable Bone AnchorAxya Medical, Inc. · 2006 · Recalled
- Descendant · 2 generations on · 7 of its ownK083268 Tornier, Inc., Insite Suture AnchorsTornier, Inc. · 2009
- Descendant · 3 generations on · 5 of its ownK110773 Tornier Insite FT Suture AnchorTornier, Inc. · 2011
- Descendant · cites it directly · 4 of its ownK982963 Polymer Threaded Anchor / Suture CombinationOrthopaedic Biosystems, Ltd. · 1998
- Descendant · 2 generations on · 3 of its ownK011985 Smith & Nephew Phoenix 5.0 Allograft Anchor KitSmith & Nephew, Inc. · 2001
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K060970Axyaloop Nonabsorbable Bone AnchorAxya Medical, Inc. · 2006 · cites it directly10descendants
- K083268Tornier, Inc., Insite Suture AnchorsTornier, Inc. · 2009 · 2 generations on7descendants
- K110773Tornier Insite FT Suture AnchorTornier, Inc. · 2011 · 3 generations on5descendants
- K982963Polymer Threaded Anchor / Suture CombinationOrthopaedic Biosystems, Ltd. · 1998 · cites it directly4descendants
- K011985Smith & Nephew Phoenix 5.0 Allograft Anchor KitSmith & Nephew, Inc. · 2001 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K963402 | Innovasive 2.8MM Roc Suture Bone Fastener and 3.5MM Roc Suture Bone Fastener | Innovasive Devices, Inc. | 1996 | — |
| +1 | K060970 | Axyaloop Nonabsorbable Bone Anchor | Axya Medical, Inc. | 2006 | 21 |
| +2 | K083268 | Tornier, Inc., Insite Suture Anchors | Tornier, Inc. | 2009 | — |
| +3 | K110773 | Tornier Insite FT Suture Anchor | Tornier, Inc. | 2011 | — |
| +1 | K982963 | Polymer Threaded Anchor / Suture Combination | Orthopaedic Biosystems, Ltd. | 1998 | — |
| +2 | K011985 | Smith & Nephew Phoenix 5.0 Allograft Anchor Kit | Smith & Nephew, Inc. | 2001 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 3 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | — | Mitek GII Anchor Named without a submission number |
What descends from it? (18)
See all 184 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?
- Of its descendants, K060970 (Axya Medical, Inc., 2006) has gone furthest, with 10 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 ROC fastener is intended for bladder neck suspension for female urinary incontinence due to 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/K963402 · printed Nov 5, 2026
Cite this page
510(k) Report. “K963402: Innovasive 2.8MM Roc Suture Bone Fastener and 3.5MM Roc Suture Bone Fastener.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K963402
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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