# K230874: Syntheface PEEK Interference Screw, Syntheface PEEK Screw Sheath

- Pathway: 510(k) (Traditional)
- Applicant: Suzhou Endophix Co., Ltd.
- Decided: May 23, 2023 after 54 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: 7 generations back to K961555 (1996). 23 ancestors in all.
No later device cites it as a predicate yet.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083635: Smith & Nephew Biosure PK Interference Screw, Smith & Nephew Endoscopy, Inc. (2009) Summary page 6.
- K093943: Biosure Sync Tibial Fixation Device, 6MM, 8MM,10MM,12MM, Smith & Nephew Inc., Endoscopy Div. (2010) Summary page 7.

## Indications for use
The Syntheface PEEK Interference Screw is 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 are also indicated for use in the following procedures: Knee -ACL Repair -PCL Repair -Extra-capsular repair Medial collateral ligament Lateral collateral ligament Posterior oblique ligament -Patellar realignment and tendon repair Vastus medialis obliquus advancement -Iliotibial band tenodesis Shoulder -Capsular stabilization Bankart repair Anterior shoulder instability SLAP lesion repair Capsular shift or capsulolabral reconstruction -Acromioclavicular separation repair -Deltoid repair -Rotator cuff tear repair -Biceps tenodesis Foot and Ankle -Hallux valgus repair -Medial or lateral instability repair/reconstruction -Achilles tendon repair/reconstruction -Midfoot reconstruction -Metatarsal ligament/tendon repairs/reconstruction -Bunionectomy -Flexor Hullucis Longus (FLH) -Tendon Transfer Elbow, Wrist, and Hand -Biceps tendon reattachment -Ulnar or radial collateral ligament reconstruction -Lateral epicondylitis repair -Scapholunate ligament reconstruction -Tendon Transfer -Carpometacarpal Joint Arthroplasty -Carpal Ligament Reconstruction The Syntheface PEEK Screw Sheath is indicated for use in combination with Syntheface PEEK Interference Screw for fixation of soft tissue to bone during cruciate ligament reconstruction.

Source page: https://510kreport.com/device/K230874
Methodology: https://510kreport.com/methodology