# K193108: Bonecam Suture Anchor

- Pathway: 510(k) (Special)
- Applicant: Valeris Medical, Inc.
- Decided: Mar 26, 2020 after 139 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: 9 generations back to K961555 (1996). 39 ancestors in all.
No later device cites it as a predicate yet.
0 of 40 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152255: BoneCam Suture Anchors, Valeris Medical (2015) Summary page 5.

## Indications for use
Shoulder • Rotator Cuff Repair • Bankart Repair • SLAP Lesion Repair • Biceps Tenodesis • Acormio-Clavicular Separation Repair • Deltoid Repair • Capsular Shift or Capsulolabral Reconstruction Hand and 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 Foot and 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 • Illiotibial band tenodesis reconstruction • Patellar ligament/tendon repair

Source page: https://510kreport.com/device/K193108
Methodology: https://510kreport.com/methodology