# K152255: BoneCam Suture Anchors

- Pathway: 510(k) (Traditional)
- Applicant: Valeris Medical
- Decided: Nov 16, 2015 after 98 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). 38 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 40 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140855: Arthrex Suturetak Suture Anchors, Arthrex, Inc. (2014) Summary page 5.
- K142230: Apollo Suture Anchor System and Titan Screws, Valeris Medical (2014) Summary page 5.

## Most influential descendants
- K193108: Bonecam Suture Anchor (2020), 0 descendants of its own

## Indications for use
Valeris BoneCam Suture Anchors are intended to be used for suture (soft tissue) fixation to bone in the foot, ankle, knee, hand, wrist, elbow, shoulder, and hip. Shoulder Rotator Cuff Repair Bankart Repair SLAP Lesion Repair Biceps Tenodesis Acormio-Clavicular Separation Repair Deltoid Repair Capisular 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 Knee Medial Collateral Ligament Repair Lateral Collateral Ligament Repair Posterior Oblique Ligament Repair Iliotibial Band Tenodesis Reconstruction Patellar Ligament/Tendon Repair 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 Elbow Biceps Tendon Reattachment Ulnar or Radial Collateral Ligament Reconstruction Hip Capsular Repair Acetabular Labral Repair

Source page: https://510kreport.com/device/K152255
Methodology: https://510kreport.com/methodology