# K980457: Endo Absorbable Interference Screw

- Pathway: 510(k) (Traditional)
- Applicant: Endo Surgical Concepts, Inc.
- Decided: Sep 8, 1998 after 215 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: 1 generation back to K935836 (1994). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K935836: Bone or Interference Screw, Endo Surgical Concepts, Inc. (1994) Summary page 1.
- K933719: Bioscrew Absorbable Interference Screw, Linvatec Corp. (1994) Summary page 1.
- K952831: Bioscrew Absorbable Interference Screw, Linvatec Corp. (1995) Summary page 1.
- K943548: Bioabsorbable Interference Screw, Acufex Microsurgical, Inc. (1995) Summary page 1.
- (no number) Richards Hewson Ligament Button: named in the summary without a submission number

## Indications for use
The ENDO Absorbable Interference Screw is indicated for use in graft fixation in the repair and reconstruction of the cruciate ligaments of the knee, during open and arthroscopic surgery.

Source page: https://510kreport.com/device/K980457
Methodology: https://510kreport.com/methodology