# K042552: Bio-Core Interference Screw

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Dec 14, 2004 after 85 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: 3 generations back to K943806 (1995). 14 ancestors in all.
4 later devices descend from it; 2 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)
- K041274: Resorbable Interference Screw, Arthrotek, Inc. (2004) Summary page 1.
- K993025: Modification to Bone Mulch Screw System, Biomet, Inc. (1999) Summary page 1.
- K991298: Bone Mulch Screw System, Biomet, Inc. (1999) Summary page 1.
- K941941: Bone Mulch Screw, Biomet, Inc. (1995) Summary page 1.

## Most influential descendants
- K140879: Biosure Healicoil PK Interference Screw (2014), 1 descendant of its own
- K071464: Inion Hexalon Biodegradable Acl/PCL Screw (2007), 1 descendant of its own
- K142948: BIOSURE REGENESORB interference Screw (2015), 0 descendants of its own
- K130716: Bioretec Activascrew Interference (2013), 0 descendants of its own

## Indications for use
Indications for the Bio-CoreTM Interference Screw include use in soft tissue reattachment procedures in the shoulder, wrist/hand, ankle/foot, elbow, and knee. Specific indications include the following: Shoulder: Bankart repair, SLAP lesion repair, acromio-ciavicular 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, medial 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 obliquus (VMO) muscle advancement. In addition to the above indications, the 7.0, 8.0, 9.0, 10.0, 11.0, and 12.0 mm 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 (semitendinosus, gracilis). 3. To provide interference fixation during posterior cruciate ligament (PCL) reconstruction.

Source page: https://510kreport.com/device/K042552
Methodology: https://510kreport.com/methodology