# K080358: Plla, HA Screw

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew Inc., Endoscopy Div.
- Decided: Apr 23, 2008 after 72 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K915424 (1993). 8 ancestors in all.
22 later devices descend from it; 2 cite it directly.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002274: Smith & Nephew Suture Hapla Interference Screw, Smith & Nephew, Inc. (2001) Summary page 1.
- K051310: PLC Screw, Smith & Nephew, Inc. (2005) Summary page 2.

## Most influential descendants
- K083635: Smith & Nephew Biosure PK Interference Screw (2009), 21 descendants of its own
- K133036: Apollo Suture Anchor System and Titan Screws (2014), 7 descendants of its own
- K142230: Apollo Suture Anchor System and Titan Screws (2014), 5 descendants of its own
- K180573: Responsive Arthroscopy Interference Screw System (2018), 2 descendants of its own
- K192810: Apollo Suture Anchor System (2020), 1 descendant of its own

## Recalls of this device
- Nov 24, 2025 · Class II · Z-0957-2026: Removal of affected lot of screws due to labeling error.
- Feb 6, 2012 · Not classified · Z-1225-2012: Mislabeled: The device was labeled as a standard thread screw (P/N 72201772) on pouch and box, however the device contained in the packaging is a reverse thread screw (P/N 72201773).

## Indications for use
The Smith & Nephew PLLA/HA Screw is indicated for fixation of bone-tendon-bone or soft tissue grafts during Anterior and/or Posterior Cruciate Ligament (ACL/PCL) reconstruction.

Source page: https://510kreport.com/device/K080358
Methodology: https://510kreport.com/methodology