# K130217: Orthopediatrics Acl Reconstructive System

- Pathway: 510(k) (Traditional)
- Applicant: OrthoPediatrics Corp.
- Decided: Jun 20, 2013 after 142 days
- Product code: MBI (Fastener, Fixation, Nondegradable, Soft Tissue)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K922559 (1992). 5 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980155: Endobutton Continuous Loop, Smith & Nephew, Inc. (1998) Summary page 1.
- K062466: Arthrex Interference Screw, Arthrex, Inc. (2006) Summary page 1.

## Most influential descendants
- K212197: WasherCap Fixation System (2022), 3 descendants of its own
- K243712: WasherCap™ Mini Fixation System (Model 45) (2025), 1 descendant of its own
- K253618: QuadLock™ Fixation System (2026), 0 descendants of its own
- K250238: WasherCap™ Fixation System (2025), 0 descendants of its own

## Recalls of this device
- Jun 5, 2020 · Class II · Z-2538-2020: ShieldLoc implant component of the ACL Reconstruction Systemlots may be labeled with the incorrect size. Product labeled as 10-1008-4070 was found to have 10-1008-4060 product in the package. Product 
- Jul 25, 2014 · Class II · Z-2560-2014: Weld fractures on the Sleeve Installation Tool for ACL reconstruction system.
- Nov 7, 2013 · Class II · Z-0579-2014: Part # 01-1008-0040/0047, ACL Sleeve Installation/ Insertion Tool, shipped November 4, 2013 - November 6, 2013 may be etched with the wrong size.

## Indications for use
The OrthoPediatrics ACL Reconstruction System is intended for fixation of tendons and ligaments during orthopedic reconstruction procedures such as Anterior Cruciate Ligament (ACL) Reconstruction.

Source page: https://510kreport.com/device/K130217
Methodology: https://510kreport.com/methodology