# K260294: SF Push-in Anchor

- Pathway: 510(k) (Traditional)
- Applicant: Surgical Fusion Technologies GmbH
- Decided: Mar 27, 2026 after 57 days
- Product code: MAI (Fastener, Fixation, Biodegradable, Soft Tissue)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K961555 (1996). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K240288: SF Push- in Anchor, Surgical Fusion Technologies GmbH (2024) Summary page 6.

## Indications for use
The SF Push-in Anchor is intended to be used for suture or tissue fixation in the foot, ankle, hand, wrist, elbow, knee, hip and shoulder. The SF Push-in Anchor is designed only to be inserted with the SupraFuser® Generator. SF Push-in Anchor 1.6mm: 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, Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty) Elbow: Ulnar or Radial Collateral Ligament Reconstruction, Shoulder: Bankart Repair, SLAP Lesion Repair, Capsular Shift or Capsulolabral Reconstruction, Foot/Ankle: Lateral Stabilization, Medial Stabilization, Metatarsal Ligament Repair, Hallux Valgus reconstruction, Digital Tendon Transfers, Mid-foot Reconstruction, Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair. SF Push-in Anchor 2.3mm: 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, Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty), Triangular Fibrocartilage Complex (TFCC) Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction, Lateral epicondylitis repair, 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, Metatarsal Ligament Repair, Hallux Valgus reconstruction, Digital Tendon Transfers, Mid-foot Reconstruction, Achilles Tendon Repair, Bunionectomy, Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, lliotibial Band Tenodesis, Hip: Acetabular labral repair, capsular repair. SF Push-in Anchor 3.0mm and 3.6mm: 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, Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty), Triangular Fibrocartilage Complex (TFCC) Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction, lateral epicondylitis repair, 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, Metatarsal Ligament Repair, Hallux Valgus reconstruction, Digital Tendon Transfers, Mid-foot Reconstruction, Metatarsal tendon repair, Bunionectomy, Knee: Medial collateral ligament repair, lateral collateral ligament repair, patellar tendon repair, posterior oblique ligament repair, and iliotibial band tenodesis, Hip: Acetabular labral repair, capsular repair.

Source page: https://510kreport.com/device/K260294
Methodology: https://510kreport.com/methodology