510(k) · Cleared
ClearedInnovasive 3.5MM Metal Roc XS 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 Jun 16, 1998 after a 75-day review. The FDA summary names its predicate without a number.
- Decided
- Jun 16, 1998
- Review
- 75 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
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 |
|---|---|---|---|
| * | — | 3.5mm Innovasive Devices ROC XS Suture Bone Fastener Named without a submission number | |
| * | — | 3.5mm Innovasive Devices ROC EZ Suture Bone Fastener Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
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.
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?
SHOULDER Bankart repair Repair of rotator cuff tears Capsular instability Slap lesion repair Acromio-clavicular separation Capsule shift/capsulolabral reconstruction Biceps tenodesis Deltoid repair KNEE Extra-capsular repairs Reattachment of medial collateral ligament Reattachment of lateral collateral ligament Reattachment of posterior oblique ligament Joint capsule closure Patellar ligament and tendon avulsion repairs Extra-capsular reconstruction ITB…
Read the full statement (94 words)
SHOULDER
Bankart repair
Repair of rotator cuff tears
Capsular instability
Slap lesion repair
Acromio-clavicular separation
Capsule shift/capsulolabral reconstruction
Biceps tenodesis
Deltoid repair
KNEE
Extra-capsular repairs
Reattachment of medial collateral ligament
Reattachment of lateral collateral ligament
Reattachment of posterior oblique ligament
Joint capsule closure
Patellar ligament and tendon avulsion repairs
Extra-capsular reconstruction
ITB tenodesis.
ANKLE
Lateral and medial instability
Achilles tendon reconstruction and repair
Mid-foot reconstructions
FOOT
Hallux valgus reconstruction
ELBOW
Tennis elbow repair
Biceps tendon reattachment
Medial and lateral repairs
BLADDER NECK SUSPENSION
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/K981193 · printed Nov 6, 2026
Cite this page
510(k) Report. “K981193: Innovasive 3.5MM Metal Roc XS Suture Bone Fastener.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K981193
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026