# K231002: Javelot PK-S suture anchor, Javelot PK-S suture anchor (Knotless), Javelot PK-P suture anchor, Javelot PK-P suture anchor (Knotless), Javelot PK-L suture anchor (Knotless)

- Pathway: 510(k) (Traditional)
- Applicant: Suzhou Endophix Co., Ltd.
- Decided: Jun 7, 2023 after 61 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: 12 generations back to K792022 (1979). 114 ancestors in all.
No later device cites it as a predicate yet.
0 of 115 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093228: Smith & Nephew Twinfix Ultra PK Suture Anchor, Smith & Nephew, Inc. (2009) Summary page 13.
- K101823: Arthrex Swivelock Anchors, Arthrex, Inc. (2011) Summary page 13.
- K203495: Arthrex SwiveLock Anchor, Arthrex, Inc. (2021) Summary page 14.
- K140855: Arthrex Suturetak Suture Anchors, Arthrex, Inc. (2014) Summary page 14.
- K061863: Arthrex Corkscrew Suture Anchor, Tak, and Pushlock Family, Arthrex, Inc. (2006) Summary page 14.
- K063479: Arthrex Pushlock, Arthrex, Inc. (2006) Summary page 14.
- K093897: Smith & Nephew Footprint Ultra PK Suture Anchor, Smith & Nephew Inc., Endoscopy Div. (2010) Summary page 14.
- K121018: Bioraptor 2.9, Bioraptor 2.3 PK, Osteoraptor, & Bioraptor Knotless Suture an, Smith & Nephew, Inc. (2012) Summary page 15.

## Indications for use
The Javelot PK-S suture anchor is intended for the reattachment of soft tissue to bone for the following indications: Shoulder: -Bankart lesion repair -SLAP lesion repair -Acromioclavicular separation repair -Rotator cuff tear repair -Capsular shift or capsulolabral reconstruction -Biceps tenodesis -Deltoid repair Foot/Ankle: -Hallux Valgus repair -Medial or lateral instability repair/reconstruction -Achilles tendon repair/reconstruction -Midfoot reconstruction -Metatarsal ligament/tendon repair/reconstruction Elbow: -Ulnar or radial collateral ligament reconstruction -Lateral epicondylitis repair -Biceps tendon reattachment 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 The Javelot PK-S suture anchor (Knotless) is intended for the reattachment of soft tissue to bone for the following indications: Shoulder: -Bankart repair -SLAP lesion repair -Acromioclavicular separation repair -Rotator cuff repair -Capsular shift or capsulolabral reconstruction -Biceps tenodesis -Deltoid repair Foot/Ankle: -Hallux Valgus reconstruction -Medial stabilization -Lateral stabilization -Achilles tendon repair -Mid-foot reconstruction -Metatarsal ligament/ tendon repair -Bunionectorny Elbow: -Ulnar/ radial collateral ligament reconstruction -Biceps tendon reattachment -Lateral epicondylitis repair Hand/Wrist: -Scapholunate ligament reconstruction -Ulnar/Radial collateral ligament reconstruction Knee: -Medial collateral ligament repair -Lateral collateral ligament repair -Posterior oblique ligament repair -Iliotibial band tenodesis -Patellar tendon repairs -Anterior cruciate ligament repair (4.75-5.5mm anchors only) -Secondary or adjunct fixation for ACL/PCL reconstruction or repair (4.75-5.5mm anchors only) -Quadriceps tendon repair (4.75 mm anchors only) -Meniscal root repair (4.75 mm anchors only) Hip: -Capsular Repair -Acetabular labral repair -Proximal hamstring repair (4.75-5.5mm anchors only) -Gluteus Medius Repair (4.75-5.5mm anchors only) The Javelot PK-P suture anchor is intended for the reattachment of soft tissue to bone for the following indications: Shoulder: -Rotator cuff repair -Bankart repair -SLAP lesion repair -Biceps tenodesis -Acromioclavicular separation repair -Deltoid repair -Capsular shift or capsulolabral reconstruction Foot/Ankle: -Lateral stabilization -Medial stabilization -Achilles tendon repair -Metatarsal ligament repair -Hallux valgus reconstruction -Digital tendon transfers -Mid-foot reconstruction Knee: -Medial collateral ligament repair -Lateral collateral ligament repair -Patellar tendon repair -Posterior oblique ligament repair -Iliotibial band tenodesis Hand/Wrist: -Scapholunate ligament reconstruction -Carpal ligament reconstruction -Repair/Reconstruction of collateral ligaments -Repair of flexor and extensor tendons at the PIP, DIP, and MCP joints for all digits -Digital tendon transfers Elbow: -Biceps tendon reattachment -Ulnar or radial collateral ligament reconstruction Hip: -Capsular repair -Acetabular labral repair The Javelot PK-P suture anchor (Knotless) is intended for the reattachment of soft tissue to bone for the following indications: Shoulder: -Bankart repair -SLAP lesion repair -Acromioclavicular separation repair -Rotator cuff repair -Capsular shift or capsulolabral reconstruction -Biceps tenodesis -Deltoid repair Foot/ Ankle: -Hallux Valgus reconstruction -Medial stabilization -Lateral stabilization -Achilles Tendon Repair -Mid-foot reconstruction -Metatarsal ligament repair/ tendon repair -Digital tendon transfers (2.5mm anchor only) -Bunionectomy (2.9-4.5mm anchors only) Elbow: -Ulnar or radial collateral ligament reconstructions -Biceps tendon reattachment -Lateral epicondylitis repair (2.9-4.5mm anchors only) Hand/ Wrist: -Scapholunate ligament reconstruction -UInar collateral ligament reconstruction (2.9-4.5mm anchors only) -Radial collateral ligament reconstruction (2.9-4.5mm anchors only) -Carpal ligament reconstruction (2.5mm anchors only) -Repair/Reconstruction of collateral ligaments (2.5mm anchors only) -Repair of Flexor and Extensor Tendons at the PIP, DIP and MCP joints for all digits (2.5mm anchors only) -Digital tendon transfers (2.5mm anchors only) Knee: -Medial collateral ligament repair -Lateral collateral ligament repair -Posterior oblique ligament repair -Iliotibial band tenodesis -Patellar tendon repairs Hip: (2.9-4.5mm anchors only) -Acetabular labral repair -Capsular repair The Javelot PK-L suture anchor (Knotless) is intended for the reattachment of soft tissue to bone for the following indications: Shoulder: -Bankart lesion repair -SLAP lesion repair -Acromioclavicular separation repair -Rotator cuff tear repair -Capsular shift or capsulolabral reconstruction -Biceps tenodesis -Deltoid repair -Anterior shoulder instability (3.7mm anchors only) Foot/ Ankle: -Hallux Valgus repair -Medial or lateral instability repair -Midfoot reconstruction -Metatarsal ligament/tendon repair/reconstruction -Achilles tendon repair/reconstruction -Bunionectomy (3.7mm anchors only) Elbow: -Ulnar or radial collateral ligament reconstruction -Biceps tendon reattachment -Lateral epicondylitis repair (3.7mm anchors only) Hand/Wrist: -Scapholunate ligament reconstruction -Ulnar collateral ligament reconstruction -Radial collateral ligament reconstruction Knee: -Medial collateral ligament repair -Lateral collateral ligament repair -Posterior oblique ligament repair -Iliotibial band tenodesis -Patellar tendon repair Hip: (3.7mm anchors only) -Hip capsule repair Acetabular labrum reattachment/ reconstruction

Source page: https://510kreport.com/device/K231002
Methodology: https://510kreport.com/methodology