510(k) · Cleared
ClearedQuestus Polyester Suture Soft Tissue Anchor System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wrightmedicaltechnologyinc · MBI Fastener, Fixation, Nondegradable, Soft Tissue
Cleared on Oct 2, 1996 after a 48-day review. The FDA summary names its predicate without a number. 41 later devices descend from it.
- Decided
- Oct 2, 1996
- Review
- 48 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 0
41 later devices descend from it, 1 citing it directly.
- This deviceK963200 Questus Polyester Suture Soft Tissue Anchor SystemWrightmedicaltechnologyinc · 1996
- Descendant · cites it directly · 40 of its ownK970292 IN-Fast Bone Screw System/in-Fast Bone Screw Inserter/in-Fast Bone…Influence, Inc. · 1997 · Recalled
- Descendant · 2 generations on · 23 of its ownK972023 Sleep-in Bone Screw SystemInfluence, Inc. · 1997
- Descendant · 2 generations on · 16 of its ownK981677 Repose Bone Screw SystemInfluence, Inc. · 1999 · Recalled
- Descendant · 3 generations on · 15 of its ownK101060 Siesta Medical, Inc., Prelude Tongue Suspension SystemSiesta Medical, Inc. · 2010
- Descendant · 4 generations on · 14 of its ownK103179 Prelude II Tounge Suspension SystemSiesta Medical, Inc. · 2010
Showing 5 of 41 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 41 · See all- K970292IN-Fast Bone Screw System/in-Fast Bone Screw Inserter/in-Fast Bone ScrewInfluence, Inc. · 1997 · cites it directly40descendants
- K972023Sleep-in Bone Screw SystemInfluence, Inc. · 1997 · 2 generations on23descendants
- K981677Repose Bone Screw SystemInfluence, Inc. · 1999 · 2 generations on16descendants
- K101060Siesta Medical, Inc., Prelude Tongue Suspension SystemSiesta Medical, Inc. · 2010 · 3 generations on15descendants
- K103179Prelude II Tounge Suspension SystemSiesta Medical, Inc. · 2010 · 4 generations on14descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K963200 | Questus Polyester Suture Soft Tissue Anchor System | Wrightmedicaltechnologyinc | 1996 | — |
| +1 | K970292 | IN-Fast Bone Screw System/in-Fast Bone Screw Inserter/in-Fast Bone Screw | Influence, Inc. | 1997 | 1 |
| +2 | K972023 | Sleep-in Bone Screw System | Influence, Inc. | 1997 | — |
| +2 | K981677 | Repose Bone Screw System | Influence, Inc. | 1999 | 2 |
| +3 | K101060 | Siesta Medical, Inc., Prelude Tongue Suspension System | Siesta Medical, Inc. | 2010 | — |
| +4 | K103179 | Prelude II Tounge Suspension System | Siesta Medical, Inc. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 3 | 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? (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 |
|---|---|---|---|
| * | — | QUESTUS™ Polyester Suture Soft Tissue Anchor System Named without a submission number |
What descends from it? (41)
See all 411 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K970292 | IN-Fast Bone Screw System/in-Fast Bone Screw Inserter/in-Fast Bone Screw | 1997 | 40 |
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, K970292 (Influence, Inc., 1997) has gone furthest, with 40 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 QUESTUS™ Polyester Suture Soft Tissue Anchor System is indicated for the following: repair of shoulder instability secondary to Bankart lesion, rotator cuff tear, a SLAP lesion, acromioclavicular separation, biceps tenodesis, deltoid tear/separation, or capsular shift or capsulolabral reconstruction; repair of elbow instability secondary to biceps tendon detachment, tennis-elbow, or ulnar or radial collateral ligament tear/separation; repair of…
Read the full statement (129 words)
The QUESTUS™ Polyester Suture Soft Tissue Anchor System is indicated for the following:
repair of shoulder instability secondary to Bankart lesion, rotator cuff tear, a SLAP lesion, acromioclavicular separation, biceps tenodesis, deltoid tear/separation, or capsular shift or capsulolabral reconstruction;
repair of elbow instability secondary to biceps tendon detachment, tennis-elbow, or ulnar or radial collateral ligament tear/separation;
repair of hand/wrist instability secondary to tear or separation of the scapholunate ligament, ulnar collateral ligament, or radial collateral ligament;
repair of knee instability secondary to tear or separation of the medial collateral ligament, lateral collateral ligament, patellar tendon, or posterior oblique ligament, or secondary to iliotibial band tenodesis;
repair of foot/ankle instability secondary to tear or separation of the Achilles tendon, lateral stabilization tendons/ligaments; medial stabilization tendons/ligaments, midfoot tendons/ligaments, or metatarsal tendons/ligaments
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/K963200 · printed Nov 4, 2026
Cite this page
510(k) Report. “K963200: Questus Polyester Suture Soft Tissue 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/K963200
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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