# K984171: Endopearl

- Pathway: 510(k) (Traditional)
- Applicant: Linvatec Corp.
- Decided: Apr 29, 1999 after 160 days
- Product code: MAI (Fastener, Fixation, Biodegradable, Soft Tissue)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
6 later devices descend from it; 1 cites it directly.
0 of 7 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) EndoButton: named in the summary without a submission number

## Most influential descendants
- K993339: Endopearl with Threader (1999), 5 descendants of its own
- K012469: Resorbable NO Profile Screw and Washer (2001), 4 descendants of its own
- K021832: Arthrotek Resorbable NO-Profile Lactosorb L-15 Screw & Washer (2002), 3 descendants of its own
- K033233: Lactosorb Tibial L-15 Screw and Washer (2003), 2 descendants of its own
- K130731: Stabiliz Fixation System - SPL Locking Screw (2013), 0 descendants of its own

## Indications for use
The EndoPearl is used in conjunction with the Linvatec BioScrew bioabsorbable interference screw, as a back-up to interference screw fixation of soft tissue grafts on the femoral side of ACL/PCL reconstruction.

Source page: https://510kreport.com/device/K984171
Methodology: https://510kreport.com/methodology