# K033519: Cannulated Arthrorivet and Cannulated RC Arthrorivet

- Pathway: 510(k) (Special)
- Applicant: Biomet, Inc.
- Decided: Dec 5, 2003 after 28 days
- Product code: HRS (Plate, Fixation, Bone)
- 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
Longest line of descent: 1 generation back to K981798 (1998). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981798: Lactosorb Pop Rivet, Biomet, Inc. (1998) Summary page 1.

## Indications for use
These devices are indicated for soft tissue reattachment in the following shoulder procedures: 1. Instability repairs in the shoulder (Bankart Procedures) 2. SLAP lesion repair 3. Acromio-clavicular separation repairs 4. Rotator cuff tear repairs 5. Capsular shift or capsulolabral reconstructions 6. Biceps tenodesis 7. Deltoid repairs

Source page: https://510kreport.com/device/K033519
Methodology: https://510kreport.com/methodology