# K051310: PLC Screw

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Jul 26, 2005 after 68 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: 24 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K915424 (1993). 6 ancestors in all.
71 later devices descend from it; 2 cite it directly.
0 of 78 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992396: Biorci Screw, Smith & Nephew Endoscopy, Inc. (2000) Summary page 1.

## Cited in the summary but kept off the family tree
- K1002274: HAPLA Interference Screw. Number could not be read Summary page 1.

## Most influential descendants
- K071176: Modification to: Arthrex Interference Screw (2007), 47 descendants of its own
- K151342: Arthrex SwiveLock Anchors (2016), 38 descendants of its own
- K171141: Arthrex SwiveLock Anchors (2017), 29 descendants of its own
- K180768: Arthrex SwiveLock Anchors (2018), 28 descendants of its own
- K080358: Plla, HA Screw (2008), 22 descendants of its own

## Recalls of this device
- Aug 21, 2007 · Not classified · Z-0593-2008: Patient Reaction: Post operative condition sterile fluid pocket has been identified, including the potential for graft failure and premature material degradation.
- Aug 21, 2007 · Not classified · Z-0604-2008: Patient Reaction: Post operative condition sterile fluid pocket has been identified, including the potential for graft failure and premature material degradation.
- Aug 21, 2007 · Not classified · Z-0609-2008: Patient Reaction: Post operative condition sterile fluid pocket has been identified, including the potential for graft failure and premature material degradation.
- Aug 21, 2007 · Not classified · Z-0610-2008: Patient Reaction: Post operative condition sterile fluid pocket has been identified, including the potential for graft failure and premature material degradation.
- Aug 21, 2007 · Not classified · Z-0596-2008: Patient Reaction: Post operative condition sterile fluid pocket has been identified, including the potential for graft failure and premature material degradation.
- Aug 21, 2007 · Not classified · Z-0598-2008: Patient Reaction: Post operative condition sterile fluid pocket has been identified, including the potential for graft failure and premature material degradation.
- Aug 21, 2007 · Not classified · Z-0600-2008: Patient Reaction: Post operative condition sterile fluid pocket has been identified, including the potential for graft failure and premature material degradation.
- Aug 21, 2007 · Not classified · Z-0605-2008: Patient Reaction: Post operative condition sterile fluid pocket has been identified, including the potential for graft failure and premature material degradation.
- Aug 21, 2007 · Not classified · Z-0606-2008: Patient Reaction: Post operative condition sterile fluid pocket has been identified, including the potential for graft failure and premature material degradation.
- Aug 21, 2007 · Not classified · Z-0607-2008: Patient Reaction: Post operative condition sterile fluid pocket has been identified, including the potential for graft failure and premature material degradation.
- Aug 21, 2007 · Not classified · Z-0608-2008: Patient Reaction: Post operative condition sterile fluid pocket has been identified, including the potential for graft failure and premature material degradation.
- Aug 21, 2007 · Not classified · Z-0611-2008: Patient Reaction: Post operative condition sterile fluid pocket has been identified, including the potential for graft failure and premature material degradation.
- Aug 21, 2007 · Not classified · Z-0595-2008: Patient Reaction: Post operative condition sterile fluid pocket has been identified, including the potential for graft failure and premature material degradation.
- Aug 21, 2007 · Not classified · Z-0597-2008: Patient Reaction: Post operative condition sterile fluid pocket has been identified, including the potential for graft failure and premature material degradation.
- Aug 21, 2007 · Not classified · Z-0599-2008: Patient Reaction: Post operative condition sterile fluid pocket has been identified, including the potential for graft failure and premature material degradation.
- Aug 21, 2007 · Not classified · Z-0601-2008: Patient Reaction: Post operative condition sterile fluid pocket has been identified, including the potential for graft failure and premature material degradation.
- Aug 21, 2007 · Not classified · Z-0602-2008: Patient Reaction: Post operative condition sterile fluid pocket has been identified, including the potential for graft failure and premature material degradation.
- Aug 21, 2007 · Not classified · Z-0603-2008: Patient Reaction: Post operative condition sterile fluid pocket has been identified, including the potential for graft failure and premature material degradation.
- Aug 21, 2007 · Not classified · Z-0612-2008: Patient Reaction: Post operative condition sterile fluid pocket has been identified, including the potential for graft failure and premature material degradation.
- Aug 21, 2007 · Not classified · Z-0615-2008: Patient Reaction: Post operative condition sterile fluid pocket has been identified, including the potential for graft failure and premature material degradation.
- Aug 21, 2007 · Not classified · Z-0616-2008: Patient Reaction: Post operative condition sterile fluid pocket has been identified, including the potential for graft failure and premature material degradation.
- Aug 21, 2007 · Not classified · Z-0594-2008: Patient Reaction: Post operative condition sterile fluid pocket has been identified, including the potential for graft failure and premature material degradation.
- Aug 21, 2007 · Not classified · Z-0613-2008: Patient Reaction: Post operative condition sterile fluid pocket has been identified, including the potential for graft failure and premature material degradation.
- Aug 21, 2007 · Not classified · Z-0614-2008: Patient Reaction: Post operative condition sterile fluid pocket has been identified, including the potential for graft failure and premature material degradation.

## Indications for use
The Smith & Nephew PLC 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/K051310
Methodology: https://510kreport.com/methodology