# K243665: Crius PEEK Suture Anchor System (Thread-Fix Anchor); Crius PEEK Suture Anchor System (Thread-Fix Ultra Anchor); Crius PEEK Suture Anchor System (Helicoil Anchor); Crius PEEK Suture Anchor System (Pile Anchor)

- Pathway: 510(k) (Traditional)
- Applicant: ZheJiang Decans Medical Devices Co., Ltd.
- Decided: Jan 31, 2025 after 65 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). 47 ancestors in all.
No later device cites it as a predicate yet.
0 of 48 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061665: Arthrex 4.5 MM, 5.5 MM and 6.5 MM Corkscrew FT, Arthrex, Inc. (2006) Summary page 7.
- 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 7.
- K113294: Smith & Nephew Healicoil PK Suture Anchor, Smith & Nephew, Inc. (2012) Summary page 7.
- K101679: Arthrex Pushlock Anchors, Arthrex, Inc. (2010) Summary page 7.
- K063479: Arthrex Pushlock, Arthrex, Inc. (2006) Summary page 7.

## Indications for use
The Crius PEEK Suture Anchor System is intended for the fixation of soft tissue to bone in the foot,ankle,hand,wrist,elbow,knee,hip and shoulder. Crius PEEK Suture Anchor System (Thread-Fix Anchor) Shoulder: Rotator Cuff Repairs Bankart Repair SLAP Lesion Repair Biceps Tenodesis Acromio-Clavicular Separation Repair Deltoid Repair Capsular Shift or Capsulolabral Reconstruction Foot/Ankle: Lateral Stabilization Medial Stabilization Achilles Tendon Repair Hallux Valgus Reconstruction Midfoot reconstruction Metatarsal Ligament Repair Knee: Anterior Cruciate Ligament Repair Medial Collateral Ligament Repair Lateral Collateral Ligament Repair Patellar Tendon Repair Posterior Oblique Ligament Repair lliotibial Band Tenodesis Elbow: Biceps Tendon Reattachment Ulnar or Radial Collateral Ligament Reconstruction Hip: Capsular Repair Acetabular labral repair. Crius PEEK Suture Anchor System (Thread-Fix Ultra Anchor) Shoulder: Rotator Cuff Repairs Bankart Repair SLAP Lesion Repair Biceps Tenodesis Acromio-Clavicular Separation Repair Deltoid Repair Capsular Shift or Capsulolabral Reconstruction Foot/ Ankle: Hallux valgus repairs Medial or lateral instability repairs/reconstructions Achilles tendon repairs/reconstructions Midfoot reconstructions Metatarsal ligament/tendon repairs/reconstructions Knee: Medial collateral ligament repair Lateral collateral ligament repair Posterior oblique ligament repair lliotibial band tenodesis Patellar realignment and tendon repairs Elbow: Ulnar or radial collateral ligament reconstructions Lateral epicondylitis repair Biceps tendon reattachment Hip: Abductor tendon repair Crius PEEK Suture Anchor System (Helicoil Anchor) Shoulder: Rotator Cuff Repairs Bankart Repair SLAP Lesion Repair Biceps Tenodesis Acromio-Clavicular Separation Repair Deltoid Repair Capsular Shift or Capsulolabral Reconstruction Foot/ Ankle: Hallux valgus repairs Medial or lateral instability repairs/reconstructions Achilles tendon repairs/reconstruction Midfoot reconstructions Metatarsal ligament/tendon repairs/reconstructions Knee: Medial collateral ligament repair Lateral collateral ligament repair Posterior oblique ligament repair lliotibial band tenodesis Patellar realignment and tendon repairs Elbow: Ulnar or radial collateral ligament reconstructions Lateral epicondylitis repair Biceps tendon reattachment Hip: Gluteal tendon repairs - Gluteus medius and gluteus minimus repair Crius PEEK Suture Anchor System (Pile Anchor) 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/Tendon Repair HALLUX Valgus Reconstruction Mid-foot Reconstruction Bunionectomy Knee: Medial Collateral Ligament Repair Lateral Collateral Ligament Repair Patellar Tendon Repair Posterior Oblique Ligament Repair lliotibial Band Tenodesis Elbow: Biceps Tendon Reattachment Tennis Elbow Repair Ulnar or Radial Collateral Ligament Reconstruction Lateral Epicondylitis Repair Hand/Wrist: Scapholunate Ligament Reconstruction Ulnar or Radial Collateral Ligament Reconstruction Hip: Acetabular Labral Repair

Source page: https://510kreport.com/device/K243665
Methodology: https://510kreport.com/methodology