# K041115: Gii Quickanchor Plus

- Pathway: 510(k) (Special)
- Applicant: Depuy Mitek, A Johnson & Johnson Company
- Decided: May 28, 2004 after 29 days
- Product code: JDR (Staple, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- 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: 1 generation back to K915889 (1992). 1 ancestor in all.
14 later devices descend from it; 4 cite it directly.
0 of 16 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 2.

## Most influential descendants
- K112876: Cufflink (TM) Knotless Anchor with Inserter, 4.5MM/5.5MM - Peek Only, Cufflink SP (TM) Knotless Anchor with Inserter, 4.5 (2011), 7 descendants of its own
- K122314: Quatro Link Knotless Anchor with Inserter, 2.9MM-Peek Only (2012), 6 descendants of its own
- K051989: Gii Quickanchor Plus with Orthocord Suture (2005), 3 descendants of its own
- K182507: Tigon Medical Tissue Anchors (2019), 2 descendants of its own
- K220464: Tigon Medical Gryphon Anchor Line (2023), 1 descendant of its own

## Recalls of this device
- May 3, 2013 · Class II · Z-1626-2013: The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.

## Indications for use
The Mitek GII Anchor (QUICKANCHOR) is intended for fixation of USP size #2 suture to bone for the indications listed below. Shoulder: Bankart repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule shift/capsulo-labral reconstruction, biceps tenodesis, deltoid repair. Ankle: Lateral instability, medial instability, achilles tendon repair/reconstruction, midfoot reconstruction. Foot: Hallux valgus reconstruction. Wrist: Scapholunate ligament. Hand: Ulnar or lateral collateral ligament reconstruction. Elbow: Tennis elbow repair, biceps tendon reattachment. Knee: Extra capsular repairs; Reattachment of: medial collateral ligament, lateral collateral ligament, posterior oblique ligament or joint capsule to tibia and joint capsule closure to anterior proximal tibia; extra capsular reconstruction, ITB tenodesis; patellar ligament and tendon avulsions.

Source page: https://510kreport.com/device/K041115
Methodology: https://510kreport.com/methodology