# K133036: Apollo Suture Anchor System and Titan Screws

- Pathway: 510(k) (Traditional)
- Applicant: Amendia, Inc.
- Decided: Mar 6, 2014 after 161 days
- Product code: MBI (Fastener, Fixation, Nondegradable, Soft Tissue)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K961555 (1996). 28 ancestors in all.
7 later devices descend from it; 3 cite it directly.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083635: Smith & Nephew Biosure PK Interference Screw, Smith & Nephew Endoscopy, Inc. (2009) Summary page 2.
- K120449: Healix Advance Peek Anchor, Depuy Mitek (2012) Summary page 2.
- K071569: Allthread Peek Anchor with Tantalum Marker, Biomet, Inc. (2007) Summary page 2.
- K060693: Microstrike and Allthread Peek Suture Anchor, Arthrotek, Inc. (2006) Summary page 2.
- K041356: Arthrex Tenodesis Screw Family, Arthrex, Inc. (2004) Summary page 2.

## Most influential descendants
- K142230: Apollo Suture Anchor System and Titan Screws (2014), 5 descendants of its own
- K192810: Apollo Suture Anchor System (2020), 1 descendant of its own
- K152255: BoneCam Suture Anchors (2015), 1 descendant of its own
- K230123: Apollo Knotless Suture Anchor (2023), 0 descendants of its own
- K230655: PEEK RCI Screw; Bio-Composite Screw; SignaLoc Screw (2023), 0 descendants of its own

## Recalls of this device
- Jul 16, 2018 · Class II · Z-0104-2019: The product was mislabeled as containing the incorrect type of suture.

## Indications for use
The Apollo Suture Anchors and Titan Screws are indicated for use in fixation of ligament, tendon, bone, or soft tissue to bone in knee, shoulder, foot/ankle, elbow, and hand/wrist procedures. The screws are intended for use in the following procedures: Indications - Apollo Medial Suture Anchor The Apollo Medial Suture Anchor is intended for: 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 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 Indications - Apollo Lateral Anchor The Apollo Lateral Anchor is indicated for: Shoulder Rotator Cuff Repair Bankart Repair SLAP Lesion Repair Biceps Tenodesis Acromioclavicular Separation Repair Deltoid Repair Capsular 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 Midfoot Forefoot Reconstruction Elbow Biceps Tendon Reconstruction Ulnar or Radial Collateral Ligament Reconstruction Lateral Epicondylitis Repair (PEEK Anchor Only) Knee Medial Collateral Ligament Repair Lateral Collateral Ligament Repair Posterior Oblique Ligament Repair Joint Capsule Closure Iliotibial Band Tenodesis Patellar Ligament/Tendon Repair Indications - Apollo Labral Suture Tac Shoulder Rotator Cuff Repair Bankart Repair SLAP Lesion Repair Biceps Tenodesis Acromioclavicular Separation Repair Deltoid Repair Capsular Shift or Capsulolabral Reconstruction Wrist Scapholunate Ligament Reconstruction Elbow Biceps Tendon Reattachment Ulnar or Radial Collateral Ligament Reconstruction Hip Capsular Repair Acetabular Labral Repair Knee Extracapsular Repair Medial Collateral Ligament Repair Lateral Collateral Ligament Repair Posterior Oblique Ligament Repair Joint Capsule Closure Iliotibial Band Tenodesis Reconstruction Patellar Ligament/Tendon Repair Vastus Medialis Obliquus Muscle Advancement Indications - Interference Screws The Titan Interference Screws are indicated for the reattachment of ligament, tendon, soft tissue, or bone to bone during cruciate ligament reconstruction surgeries of the knee. All screws with a diameter of 9 mm or less and a length of 23 mm or less are also intended for use in the following procedures: Knee ACL repairs PCL repairs Extracapsular repairs Medial collateral ligament Lateral collateral ligament Posterior oblique ligament Patellar realignment and tendon repairs Vastus medialis obliquus advancement Iliotibial band tenodesis Shoulder Capsular stabilization Bankart repair Anterior shoulder instability SLAP lesion repairs Capsular shift of capsulolabral reconstructions Acromioclavicular separation repairs Deltoid repairs Rotator cuff tear repairs Biceps tenodesis Foot and Ankle Hallux valgus repairs Medial or lateral instability repairs/reconstructions Achilles tendon repairs/reconstructions Midfoot reconstructions Metatarsal ligament/tendon repairs/reconstructions Bunionectomy Flexor Hallucis Longus Tendon transfers Elbow, Wrist, and Hand Biceps tendon reattachment Ulnar or radial collateral ligament reconstructions Lateral epicondylitis repair Scapholunate ligament reconstruction Tendon transfers Indications - Tenodesis Screws The Titan Tenodesis Screws are intended to be used for fixation of tissue, including ligament or tendon to bone, or a bone/tendon to bone. See below for specific indications. The Tenodesis Screws are intended to provide soft tissue reattachment (i.e. fixation of ligament and tendon graft tissue). See below for specific indications. Shoulder Capsular stabilization Bankart repair Anterior shoulder instability SLAP lesion repairs Capsular shift of capsulolabral reconstructions Acromioclavicular separation repairs Deltoid repairs Rotator cuff tear repairs Biceps tenodesis Foot and Ankle Hallux valgus reconstruction Medial stabilization Lateral stabilization Achilles Tendon Repair Midfoot reconstructions Metatarsal ligament repair Bunionectomy Flexor Hallucis Longus for Achilles Tendon reconstruction Tendon transfers in the foot and ankle Knee Medial Collateral Ligament Repair Lateral Collateral Ligament Repair Patellar Tendon Repair Posterior Oblique Ligament Repair Iliotibial Band Tenodesis Posterior Cruciate Ligament Repair Elbow Biceps tendon reattachment Ulnar or radial collateral ligament reconstruction Wrist and Hand Scapholunate Ligament Reconstruction Ulnar Collateral Ligament Reconstruction Radial Collateral Ligament Reconstruction Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty) Carpal Ligament Reconstructions and repairs Tendon transfer in the hand/wrist Lateral Epicondylitis repair

Source page: https://510kreport.com/device/K133036
Methodology: https://510kreport.com/methodology