# K973758: Bioscrew Absorbable Interference Srew

- Pathway: 510(k) (Traditional)
- Applicant: Linvatec Corp.
- Decided: Feb 27, 1998 after 148 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
No predicates in its family tree.
416 later devices descend from it; 10 cite it directly.
0 of 417 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Linvatec BioScrew Absorbable Interference Screw: named in the summary without a submission number
- (no number) Arthrex Interference Screws: named in the summary without a submission number
- (no number) Arthrotek Interference Screw: named in the summary without a submission number

## Most influential descendants
- K990194: Biobutton (1999), 310 descendants of its own
- K033717: Transet Fracture Fixation System (2004), 309 descendants of its own
- K043248: Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel. Model AR-8921DS (2005), 306 descendants of its own
- K052776: Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models AR-2257, AR-TBD (2005), 217 descendants of its own
- K083070: Toggleloc System (2008), 94 descendants of its own

## Indications for use
1. The BioScrew is used to provide interference fixation of patellar bone-tendon-bone grafts in anterior cruciate ligament reconstruction. 2. The BioScrew is used to provide interference fixation during femoral and/or tibial fixation in anterior cruciate ligament reconstruction using a soft tissue graft (semitendinosus, gracilis). 3. The BioScrew is used to provide interference fixation during posterior cruciate ligament reconstruction. Implantation of the interference screw is accomplished through arthroscopy or arthrotomy. This device is a single-use device.

Source page: https://510kreport.com/device/K973758
Methodology: https://510kreport.com/methodology