# K970829: Phusis Absorbable Interference Screw

- Pathway: 510(k) (Traditional)
- Applicant: Tornier
- Decided: Dec 22, 1998 after 656 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 K895711 (1990). 2 ancestors in all.
17 later devices descend from it; 1 cites it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K933719: Bioscrew Absorbable Interference Screw, Linvatec Corp. (1994). Our OCR of the scanned summary read K933718, FDA’s number for Mugnier Jerik Sunglasses (Huntley Global Ent.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “BioScrew Fixation System”. Summary page 3.
- K895711: Acufex Interference Screw, Sterile, Acufex Microsurgical, Inc. (1990) Summary page 2.

## Most influential descendants
- K993073: Smart Screw Acl Models 237020, 237025, 237030, 238020, 238025, 238030, 239020, 239025, 239030 (1999), 16 descendants of its own
- K032894: Osteo Acl Screw Model;237020T, 237025T, 237030T, 238020T, 238025T, 238030T, 239020T, 239025T, 239030T, 231020T, 231025T, (2004), 15 descendants of its own
- K052080: Matryx Interference Screw (2005), 13 descendants of its own
- K101100: Crossft OC Suture Anchor Mode CFC-4502, CFC-5502, CFC-6502, CFC-4503, CFC-5503, CFC-6503 (2010), 5 descendants of its own
- K063588: Matryx Interference Screw, 239038T5,231025T5,231033T5,231038T5,231125T5,231133T5,231138T5 (2007), 3 descendants of its own

## Indications for use
Interference fixation of patellar bone-tendon-bone grafts in ACL reconstruction. Open Surgical Reconstruction of the Anterior Cruciate Ligament (ACL) Arthroscopic ACL Reconstruction

Source page: https://510kreport.com/device/K970829
Methodology: https://510kreport.com/methodology