# K041274: Resorbable Interference Screw

- Pathway: 510(k) (Traditional)
- Applicant: Arthrotek, Inc.
- Decided: Jul 28, 2004 after 77 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K943806 (1995). 10 ancestors in all.
26 later devices descend from it; 6 cite it directly.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982497: Arthrotek Interference Screw, Biomet, Inc. (1998) Summary page 2.
- K012572: Soft Tissue Screw and Washer, Biomet, Inc. (2001) Summary page 1.
- K012872: Resorbable Screw Anchor, Arthrotek, Inc. (2001)

## Most influential descendants
- K070389: Peek Knotless Anchors (2007), 9 descendants of its own
- K110230: Rog Knotless Suture Anchor (2011), 7 descendants of its own
- K061801: 2.8 & 3.5MM Lactoscrew Suture Anchors (2006), 7 descendants of its own
- K080088: Biomet Sports Medicine Anchor Devices and Ziploop Constructs (2008), 6 descendants of its own
- K111590: Rog Suture Anchor, Rog Knotless Suture Anchor (2011), 5 descendants of its own

## Recalls of this device
- Mar 28, 2018 · Class II · Z-1737-2018: Specific lots of the device were overexposed during EtO sterilization. This may lead to revision due to infection from loss of sterile barrier during over-exposure cycle.
- Mar 28, 2018 · Class II · Z-1738-2018: Specific lots of the device were overexposed during EtO sterilization. This may lead to revision due to infection from loss of sterile barrier during over-exposure cycle.
- Mar 28, 2018 · Class II · Z-1736-2018: Specific lots of the device were overexposed during EtO sterilization. This may lead to revision due to infection from loss of sterile barrier during over-exposure cycle.
- Mar 28, 2018 · Class II · Z-1735-2018: Specific lots of the device were overexposed during EtO sterilization. This may lead to revision due to infection from loss of sterile barrier during over-exposure cycle.
- Jun 3, 2015 · Class II · Z-1944-2015: Part Number: 905620 Lot: 824610 Gentle Threads Interference Screw 10x25mm Round Head is mixed with the Part Number: 905627 Lot: 753410 Gentle Threads Interference Screw 9x35mm Full Thread. If the inco

## Indications for use
Indications for the Resorbable Interference Screw includes use in soft tissue reattachment procedures in the shoulder, wrist/hand, snkle/foot, elbow, and knee. Specific indications include the following: Shoulder: Bankart repair, SLAP lesion repair, acromio-clavieular separation, rotator cuff repair, capsule repair or capsulolabral reconstruction, biceps tenodesis, deltoid repair. Wrist/Hand: Scapholunate ligament reconstruction, ulnar/radial collateral ligament reconstruction. Ankle/Foot: Lateral stabilization, medial stabilization, Achilles tendon repair/reconstruction, hallux valgus reconstruction, mid- and forefoot reconstruction. Elbow: Tennis elbow repair, ulnar or radial collateral ligament reconstruction, biceps tendon reconstruction. Knee: Extra-capsular repair, mediac collateral ligament (MCL) repair, lateral collateral ligament (LCL) repair, posterior oblique ligament repair, joint capsule closure, iliotibial band tenodesis reconstruction, patellar ligament/tendon repair, and vastus medialis obliquns (VMO) muscle advancement. In addition to the above indications, the 7.0, 8.0, 9.0, 10.0, 11.0, and 12.0 mnm screws are indicated for the following uses: 1. To provide interference fixation of patellar bone-tendon-bone grafts in anterior cruciate ligament (ACL) reconstruction. 2. To provide interference fixation during femoral and/or tibial fixation in anterior cruciate ligament reconstruction using a soft tissue graft (senitendinosus, gracilis). 3. To provide interference fixation during posterior cmeciate ligament (PCL) reconstruction.

Source page: https://510kreport.com/device/K041274
Methodology: https://510kreport.com/methodology