# K122596: Arthroscopic Surgical Instruments - Interference Screw Systems

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Nov 20, 2012 after 88 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: 6 generations back to K961555 (1996). 22 ancestors in all.
No later device cites it as a predicate yet.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083226: Smith & Nephew Peek Interference Screw, Smith & Nephew Endoscopy, Inc. (2009) Summary page 1.
- K083635: Smith & Nephew Biosure PK Interference Screw, Smith & Nephew Endoscopy, Inc. (2009) Summary page 1.
- K002274: Smith & Nephew Suture Hapla Interference Screw, Smith & Nephew, Inc. (2001) Summary page 1.
- K921481: Interference-Cannu-Flex/Silk Screws-Screw DR/G Wir, Acufex Microsurgical, Inc. (1993) Summary page 1.
- K984320: Bioabsorbable Interference Screws, Smith & Nephew, Inc. (1999) Summary page 1.
- K992945: Rci Fixation Screws (with Assorted Sizes), Smith & Nephew, Inc. (1999). Our reading of the summary gave K092945, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Smith & Nephew RCI Fixation Screws”.

## Indications for use
Smith & Nephew Arthroscopic Surgical Instruments-Interference Screw Systems are surgical instruments used in arthroscopic surgery to facilitate the implantation of Interference Screw Systems for their cleared Indications for Use. The Smith & Nephew PEEK Interference Screws are indicated for the reattachment of ligament, tendon or soft tissue to bone for the following: Shoulder: Bankart Repair, Anterior Shoulder Instability, SLAP lesion repairs, Capsular shift or capsulolabral reconstruction, Acromioclavicular separation repairs, Deltoid repairs, Rotator cuff tear repairs, Biceps tenodesis Foot/Ankle: Hhllux Valgus, Lateral stabilization, Medial stabilization, Achilles Tendon repair/recon, Midfoot reconstruction, Metatarsal Ligament/tendon repair, Bunionectomy, Flexor Hullucis Longus repair, Tendon Transfers. Elbow/Hand/Wrist: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Recon, Lateral Epicondylitis Repair, Scapholunate Ligament Recon, Tendon Transfers, Carpomnetacarpal Joint Arthroplasty, Carpal Ligament Recon/Repair Knee: Medial or Lateral Collateral ligament, Posterior oblique ligament, Vasus medialis obliquous advancement, iliotibial band tenodesis, ACL Repairs, MCL Repairs, LCL Repairs, Patellar tendon repair, Posterior Oblique ligament repair. Smith & Nephew Arthroscopic Surgical Instruments-Interference Screw Systems are surgical instruments used in arthroscopic surgery to facilitate the implantation of Interference Screw Systems for their cleared 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 Iliotibial band t~nodesis Shoulder Capsular stabilization Bankart repair Anterior shoulder instability SLAP lesion repairs Capsular shift or capsulolabral reconstructions Acromioclavicular separation repairs Deltoid repairs Rotator cuff tear repairs Biceps tenodesjs 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 e picondylitis repair Scapholunate ligament reconstruction Tendon Transfers Carpometacarpal Joint Arthroplasty Carpal Ligament Reconstruction Smith & Nephew Arthroscopic Surgical Instruments-Interference Screw Systems are surgical instruments used in arthioscopic surgery to facilitate the implantation of Interference Screw Systems for their cleared Indications for Use. The Smith & Nephew HA-PLA Interference Screw is indicated for fixation of bone-tendon-bone or soft tissue grafts during anterior or posterior cruciate ligament reconstruction surgery. Smith & Nephew Arthroscopic Surgical Instruments-nterference Screw Systems are surgical instruments used in arthroscopic surgery to facilitate the implantation of Interference Screw Systems for their cleared Indications for Use. The Cannu-Flex Silk Screw is an Interference Screw, indicated for tendon/ligament graft fixation. Smith & Nephew Artoscopic Surgical Instruments-Interference Screw Systems are surgical instruments used in arthroscopic surgery to facilitate the implantation of Interference Screw Systems for their cleared Indications for Use. 1. The Bioabsorbable Interference Screw is used for fixation of bone-tendon-bone or soft-tissue grafts during Anterior and/or Posterior Cruciate Ligament (ACL/PCL) reconstruction. 2. The screw is indicated for single use only. Smith & Nephew Arthroscopic Surgical Instruments-Interference Screw Systems are surgical instruments used in arthroscopic surgery to facilitate the implantation of Interference Screw Systems for their cleared Indications for Use; RCI Fixation Screws are used for interference fixation of Bone-Tendon-Bone or soft tissue grafts in anterior or posterior cruciate ligament reconstruction.

Source page: https://510kreport.com/device/K122596
Methodology: https://510kreport.com/methodology