# K231033: CEPTRE® Knotted UHMWPE Suture PEEK Anchor

- Pathway: 510(k) (Traditional)
- Applicant: Healthium Medtech Limited
- Decided: Jan 4, 2024 after 268 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: 8 generations back to K961555 (1996). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143745: Arthrex Corkscrew and SwiveLock Suture Anchors, Arthrex, Inc. (2015) Summary page 6.
- K140855: Arthrex Suturetak Suture Anchors, Arthrex, Inc. (2014) Summary page 6.

## Indications for use
The CEPTRE® Knotted UHMWPE Suture PEEK Anchor are indicated in surgical procedures for soft tissue fixation to bone in the foot, ankle, knee, hand, wrist, elbow, shoulder and hip for the following indications: 1. Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair Capsular Shift or Capsulolabral Reconstruction. 2. Foot/Ankle: Lateral Stabilization, Medial stabilization, Achilles Tendon repair, Hallux Valgus reconstruction, Mid-foot reconstruction, Metatarsal ligament repair/tendon repair, Digital tendon transfers and Bunionectomy. 3. Knee: Anterior Cruciate Ligament Repair, Medial Collateral ligament repair, Lateral collateral ligament repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair and Iliotibial band tenodesis. 4. Hand/Wrist: Scapholunate ligament reconstruction, Ulnar or Radial Collateral 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. 5. Elbow: Biceps tendon reattachment, Tennis Elbow Repair, Ulnar or Radial collateral ligament reconstruction, and lateral Epicondylitis repair. 6. Hip: Acetabular labral repair, Capsular repair and gluteus medius repair.

Source page: https://510kreport.com/device/K231033
Methodology: https://510kreport.com/methodology