# K012465: Multitak Splinter 3.0 MM Resorbable Anchor

- Pathway: 510(k) (Traditional)
- Applicant: Bonutti Research, Inc.
- Decided: Oct 29, 2001 after 89 days
- Product code: MAI (Fastener, Fixation, Biodegradable, Soft Tissue)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
310 later devices descend from it; 1 cites it directly.
0 of 311 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Mitek 3.5 mm Panalok Wedge Absorbable Suture System: named in the summary without a submission number
- (no number) Multitak suture anchors: named in the summary without a submission number

## Most influential descendants
- K033717: Transet Fracture Fixation System (2004), 309 descendants of its own
- K043248: Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel. Model AR-8921DS (2005), 306 descendants of its own
- K052776: Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models AR-2257, AR-TBD (2005), 217 descendants of its own
- K083070: Toggleloc System (2008), 94 descendants of its own
- K112437: Arthrex Fracture System (2011), 91 descendants of its own

## Indications for use
The Multitak Splinter 3.0 mm Resorbable Anchor System consists of a single use bone soft tissue resorbable anchor implant and is intended for use as a load bearing or non-load bearing suture anchor in the attachment of soft tissue to bone in various arthroscopic and open orthopedic procedures. The Multitak Splinter 3.0 mm Resorbable Anchors are indicated for use in the following orthopedic soft tissue to bone fixation applications: Shoulder: Bankart lesion repairs Acromio-clavicular repairs Deltoid repairs Rotator cuff tear repairs Biceps tenodesis Elbow: Ulnar or radial collateral ligament reconstruction Knee: Extra-capsular repairs Medial collateral ligament repair Lateral collateral ligament repair Posterior oblique ligament repair Iliotibial band tenodesis Patellar tendon repair VMO advancement Joint capsule closure Foot/Ankle: Medial/Lateral repairs/reconstructions Achilles tendon repairs

Source page: https://510kreport.com/device/K012465
Methodology: https://510kreport.com/methodology