# K040475: Micromax Suture Anchor

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: May 21, 2004 after 87 days
- Product code: HWC (Screw, Fixation, Bone)
- 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: 2 generations back to K931519 (1994). 5 ancestors in all.
7 later devices descend from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012572: Soft Tissue Screw and Washer, Biomet, Inc. (2001) Summary page 1.

## Most influential descendants
- K080088: Biomet Sports Medicine Anchor Devices and Ziploop Constructs (2008), 6 descendants of its own
- K110473: Nanotack Suture Anchor 1.4MM (2011), 2 descendants of its own
- K193402: ALLthread PEEK Suture Anchor (2020), 0 descendants of its own
- K192942: ALLthread Titanium Suture Anchor (2020), 0 descendants of its own
- K123485: Juggerknotless Soft Anchors, Juggerknotless M Soft Anchors, Juggerknotless Soft Anchors with Needles, Juggerknotless Sof (2013), 0 descendants of its own

## Recalls of this device
- Dec 11, 2009 · Not classified · Z-0611-2010: The anchor label states it contains a flexible shaft, but this lot actually contians a rigid shaft.

## Indications for use
Indications for the MicroMax™ Suture Anchor include use in soft tissue reattachment procedures in the shoulder, wrist, elbow and knee. Specific indications are as follows: Shoulder Indications. · Bankart repair · SLAP lesion repair · Acromioclavicular (ACL) separation · Rotator cuff repair · Capsule repair or capsuloabral reconstruction · Biceps tenodesis • Deltoid repair Wrist Indications: · Scapholunate ligament reconstruction Tennis elbow repair Ulnar or radial collateral ligament reconstruction Biceps tendon reattachment *Medial and lateral repairs Knee Indications (Extra-capsularrepair). * 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 (VMO) muscle advancement The device is pre-loaded with suture for use at the discretion of the physician.

Source page: https://510kreport.com/device/K040475
Methodology: https://510kreport.com/methodology