# K083635: Smith & Nephew Biosure PK Interference Screw

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew Endoscopy, Inc.
- Decided: Jan 30, 2009 after 53 days
- Product code: MBI (Fastener, Fixation, Nondegradable, Soft Tissue)
- 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: 5 generations back to K961555 (1996). 18 ancestors in all.
21 later devices descend from it; 11 cite it directly.
0 of 40 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080358: Plla, HA Screw, Smith & Nephew Inc., Endoscopy Div. (2008) Summary page 1.
- K071586: Bioraptor 2.3 PK Suture Anchor, Smith & Nephew Inc., Endoscopy Division (2007) Summary page 1.
- K062466: Arthrex Interference Screw, Arthrex, Inc. (2006) Summary page 1.

## Most influential descendants
- 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
- K190892: MectaScrew PEEK Interference Screw (2019), 1 descendant of its own

## Indications for use
The Smith & Nephew BIOSURE PK Interference Screws are indicated for the reattachment of ligament, tendon, soft tissue, or bone to bone during cruciate ligament reconstruction surgeries of the knee. All screws with a diameter of 9mm or less and a length of 25mm or less are also intended for use in the following procedures: Knee : ACL Repairs : PCL Repairs * Extra-capsular repairs - Medial collateral ligament - Lateral collateral ligament - Posterior oblique ligament * Patellar realignment and tendon repairs - Vastus medialis obliquous advancement 1iliotibial band tenodesis Shoulder * Capsular stabilization - Bankart repair - Anterior shoulder instability - SLAP lesion repairs - Capsular shift or capsulolabral reconstructions * Acromilavicular separation repairs · Deltoid repairs * Rotator cuff tear repairs · Biceps tenodesis Foot and Ankle * Hallux valgus repairs · Medial or lateral instability repairs/reconstructions · Achilles tendon repairs/reconstructions * Midfoot reconstructions · Metatarsal ligament/tendon repairs/reconstructions · Bunionectomy * Flexor Hullucis Longus (FLH) * Tendon Transfers Elbow, Wrist, and Hand · Biceps tendon reattachment * Ulnar or radial collateral ligament reconstructions · Lateral epicondylitis repair * Scapholunate ligament reconstruction · Tendon Transfers * Carpometacarpal Joint Arthroplasty * Carpal Ligament Reconstruction

Source page: https://510kreport.com/device/K083635
Methodology: https://510kreport.com/methodology