# K963200: Questus Polyester Suture Soft Tissue Anchor System

- Pathway: 510(k) (Traditional)
- Applicant: Wrightmedicaltechnologyinc
- Decided: Oct 2, 1996 after 48 days
- Product code: MBI (Fastener, Fixation, Nondegradable, Soft Tissue)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
41 later devices descend from it; 1 cites it directly.
0 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) QUESTUS™ Polyester Suture Soft Tissue Anchor System: named in the summary without a submission number

## Most influential descendants
- K970292: IN-Fast Bone Screw System/in-Fast Bone Screw Inserter/in-Fast Bone Screw (1997), 40 descendants of its own
- K972023: Sleep-in Bone Screw System (1997), 23 descendants of its own
- K981677: Repose Bone Screw System (1999), 16 descendants of its own
- K101060: Siesta Medical, Inc., Prelude Tongue Suspension System (2010), 15 descendants of its own
- K103179: Prelude II Tounge Suspension System (2010), 14 descendants of its own

## Indications for use
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

Source page: https://510kreport.com/device/K963200
Methodology: https://510kreport.com/methodology