# K083226: Smith & Nephew Peek Interference Screw

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew Endoscopy, Inc.
- Decided: Jan 30, 2009 after 88 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). 9 ancestors in all.
9 later devices descend from it; 4 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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
- K091093: Parcus Ppek CF Interference Screw (2009), 4 descendants of its own
- K170877: Parcus SLiK Fix Screw (2017), 1 descendant of its own
- K140879: Biosure Healicoil PK Interference Screw (2014), 1 descendant of its own
- K111471: Exoshape (TM) Interference Fixation Device Model 1100-00-XXXX (Varies by Size) (2011), 1 descendant of its own
- K200428: Multi-Drive Interference Screw System (2020), 0 descendants of its own

## 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 reconstruIction, Acromioclavicular separation repairs, Deltoid repairs, Rotator cuff tear repairs, Biceps tenodesis Foot/Ankle: Hallux 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, Carpometacarpal Joint Arthroplasty, Carpal Ligament Recon / Repair Knee: Medial or Lateral Collateral ligament, Posterior oblique ligament, Vastus medialis obliquous advancement, iliotibial band tenodesis, ACL Repairs, MCL Repairs, LCL Repairs, Patellar tendon repair, Posterior Oblique ligament repair

Source page: https://510kreport.com/device/K083226
Methodology: https://510kreport.com/methodology