# K232725: Javelot Ti Suture Anchor, Javelot Ti-D Suture Anchor

- Pathway: 510(k) (Traditional)
- Applicant: Suzhou Endophix Co., Ltd.
- Decided: Nov 2, 2023 after 57 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
Longest line of descent: 10 generations back to K961555 (1996). 43 ancestors in all.
No later device cites it as a predicate yet.
0 of 44 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100159: Smith and Nephew Twinfix Ultra TI Suture Anchor, Smith & Nephew Inc., Endoscopy Div. (2010) Summary page 6.
- K152566: PEBA Anchor/Suture Combination, 2.0mm Mini-Tac Anchor, Model 10-1629-01, Modification to Twinfix Ti Quick-T, Twinfix FT PK, Twinfix Ultra Ti, Twinfix Ultra PK, Twinfix Ultra HA Suture Anchors, FOOTPRINT Ultra OK Suture Anchors, BIORAPTOR 2.9 Suture Anchor, BIORAPTOR 2.3 PK Suture Anchor, OSTEORAPTOR Suture Anchor, BIORAPTOR Knotless Suture Anchor,  HEALICOIL PK Suture Anchor (formerly Next Generation Fully Threaded Suture Anchor), Bioraptor Curved 2.3 PK Suture Anchors, Smith & Nephew, Inc. (2015) Summary page 6.

## Indications for use
The Javelot Ti and Javelot Ti-D Suture Anchor are intended for connection and fixation of soft tissue to bone in the knee, hip, shoulder, elbow, ankle, foot, wrist and hand for the following indications: Shoulder: • Bankart lesion repair • SLAP lesion repair • Acromio-clavicular separation repair • Rotator cuff tear repair • Capsular shift or capsulolabral reconstruction • Biceps tenodesis • Deltoid repair Foot and Ankle: • Hallux valgus repair • Medial or lateral instability repair/reconstruction • Achilles tendon repair/reconstruction • Midfoot reconstruction • Metatarsal ligament/tendon repair/reconstruction Elbow, Wrist and Hand: • Ulnar or radial collateral ligament reconstruction • Lateral epicondylitis repair • Biceps tendon reattachment • Scapholunate ligament reconstrontion (not for 4.5-6.5mm pro anchors) Knee: • Extra-capsular repair - Medial collateral ligament - Lateral collateral ligament - Posterior oblique ligament • Iliotibial band tenodesis • Patellar realignment and tendon repair - Vastus medialis obliquus advancement Hip: (2.8-6.5mm anchors only) • Capsular repair • Acetabular labral repair

Source page: https://510kreport.com/device/K232725
Methodology: https://510kreport.com/methodology