# K112417: Various

- Pathway: 510(k) (Traditional)
- Applicant: Depuy Mitek, A Johnson & Johnson Company
- Decided: Jan 13, 2012 after 143 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: 5 generations back to K010673 (2001). 23 ancestors in all.
No later device cites it as a predicate yet.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K915889: Mitek Bone Anchor, Modification, Mitek Surgical Products, Inc. (1992) Summary page 1.
- K111631: Gil Anchor / Gil Quick Anchor Plus, Healix TI Dual Threaded Suture Anchor, Rotator Cuff Anchor / Rotator Cuff Quick an.., Depuy Mitek, A Johnson & Johnson Company (2011) Summary page 1.

## Indications for use
SHOULDER: Acromio-clavicular; Bankart repair; Biceps tenodesis; Capsule shift/capsulolabral reconstruction; Deltoid repair; Rotator cuff repair; SLAP lesion repair. ANKLE: Achilles tendon repair/reconstruction; Lateral instability; Medial instability; Midfoot reconstructions. FOOT: Hallux valgus reconstruction. WRIST: Scapholunate ligament reconstruction. HAND: Ulnar or lateral collateral ligament reconstruction. ELBOW: Biceps tendon reattachment; Tennis elbow repair. KNEE: Extra capsular reconstruction, ITB tenodesis; Lateral collateral ligament; Patellar ligament and tendon avulsion repairs; Posterior oblique ligament or joint capsule to tibia; Joint capsule closure to anterior proximal tibia; Medial collateral ligament. BNS: Fixation in pubic bone for bladder neck suspension using USP #2 Class I nonabsorbable synthetic suture (e.g. polypropylene). A minimum of 2 Anchors should be used in this procedure.

Source page: https://510kreport.com/device/K112417
Methodology: https://510kreport.com/methodology