# K192810: Apollo Suture Anchor System

- Pathway: 510(k) (Special)
- Applicant: Valeris Medical
- Decided: Mar 11, 2020 after 162 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). 30 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142230: Apollo Suture Anchor System and Titan Screws, Valeris Medical (2014) Summary page 5.

## Most influential descendants
- K230123: Apollo Knotless Suture Anchor (2023), 0 descendants of its own

## Indications for use
Apolio Medial, Medial with Needles, and Apollo XT Suture Anchor: Shoulder Rotator Cuff Repair Bankart Repair SLAP Lesion Repair Biceps Tenodesis Acromio-Clavicular Separation Repair Deltoid Repair Capisular Shift or Capsulolabral Reconstruction Foot/Ankle Lateral Stabilization Medial Stabilization Achilles Tendon Repair Knee Medial Collateral Ligament Repair Lateral Collateral Ligament Repair Posterior Oblique Ligament Repair Iliotibial Band Tenodesis Elbow Biceps Tendon Reattachment Ulnar or Radial Collateral Ligament Reconstruction Hip Capsular Repair Acetabular Labral Repair Apollo Knotless Anchor Shoulder Rotator Cuff Repair Bankart Repair SLAP Lesion Repair Biceps Tenodesis Acromio-Clavicular Separation Repair Deltoid Repair Capisular Shift or Capsulolabral Reconstruction Wrist/Hand Scapholunate Ligament Reconstruction Ulnar/Radial Collateral Ligament Reconstruction Foot/Ankle Lateral Stabilization Medial Stabilization Achilles Tendon Repair/Reconstruction Hallux Valgus Reconstruction Mid- and Forefoot Reconstruction Elbow Biceps Tendon Reconstruction Ulnar or Radial Collateral Ligament Reconstruction Knee Medial Collateral Ligament Repair Lateral Collateral Ligament Repair Posterior Oblique Ligament Repair Joint Capsule Closure Iliotibial Band Tenodesis Patellar Ligament/Tendon Repair

Source page: https://510kreport.com/device/K192810
Methodology: https://510kreport.com/methodology