# K983592: Sulzer Orthopedics Sysorb Interference Screws

- Pathway: 510(k) (Traditional)
- Applicant: Sulzer Orthopedics, Inc.
- Decided: Jan 28, 1999 after 107 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.
19 later devices descend from it; 2 cite 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)
- None. The FDA summary names its predicate without a number.
- (no number) Smith & Nephew (Acufex) Endo-Fix: named in the summary without a submission number
- (no number) Instrument Makar Biologically Quiet: named in the summary without a submission number
- (no number) Arthrex Bio-Interference: named in the summary without a submission number
- (no number) Linvatec Bioscrew: named in the summary without a submission number

## 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
The Sulzer Orthopedics Sysorb Interference Screws are intended for use in the following diagnostic indications: 1. Tibial and femoral fixation (primary anchorage) of the autologous tendon-transplants as it is used in the reconstruction of the cruciate ligaments of the human knee.

Source page: https://510kreport.com/device/K983592
Methodology: https://510kreport.com/methodology