# K032830: Plla Cannulated Interference Screw

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Biomaterials
- Decided: Dec 14, 2004 after 460 days
- Product code: HWC (Screw, Fixation, Bone)
- 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: 1 generation back to K971358 (1997). 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)
- K971358: Bio-Interference Screw, 7 MM, 8 MM, 9 MM, Arthrex, Inc. (1997) Summary page 1.

## Cited in the summary but kept off the family tree
- K011368: Dry AC Acid Concentrate Mix for Bicarbonate Hemodialysis, Gambro Renal Products (2001). Our reading of the summary gave K011368, FDA’s number for Dry AC Acid Concentrate Mix for Bicarbonate Hemodialysis (Gambro Renal Products). Its FDA name has none of the distinctive words the summary uses for the device it names, “FMS Cannulated bioabsorbable interference screw”. Kept off the family tree.

## Indications for use
To provide interference fixation of soft tissue graft and bone-tendon-bone patellar graft during the Anterior Cruciate Ligament repair through arthroscopy or arthrotomy.

Source page: https://510kreport.com/device/K032830
Methodology: https://510kreport.com/methodology