# K140397: Paralock Plating System / Tuffnek Screw

- Pathway: 510(k) (Traditional)
- Applicant: Paragon 28
- Decided: Apr 17, 2014 after 58 days
- Product code: HRS (Plate, Fixation, Bone)
- 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
Longest line of descent: 12 generations back to K954385 (1996). 182 ancestors in all.
31 later devices descend from it; 7 cite it directly.
0 of 214 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011118: Normed Extremity Titanium Hand and Small Fragment System, Osteomedics (2001) Summary page 1.
- K022324: Normed Titanium Calcaneus Plating with Locking Screw System, Osteomedics, Inc. (2002) Summary page 1.
- K022325: Normed Titanium Osteotomy Plating System, Osteomedics, Inc. (2002) Summary page 1.
- K120359: Ortholoc 3DI Hallux System, Wrightmedicaltechnologyinc (2012) Summary page 1.
- K121425: Ortholoc 3DI Ankle Fusion Plating System, Wrightmedicaltechnologyinc (2012) Summary page 1.
- K121651: Ortholoc 3DI Midfoot/Flatfoot System, Wrightmedicaltechnologyinc (2012) Summary page 1.
- K043583: Charlotte Snap-Off Screw, Models 45110001, 45110002, 45110003, Wrightmedicaltechnologyinc (2005) Summary page 1.
- K050819: Charlotte Snap-Off Screw, Wrightmedicaltechnologyinc (2005) Summary page 1.
- K924018: M3 Lag Screw Fixation System, Osteomed Corp. (1993) Summary page 1.
- K032187: Anthrex Titanium Opening Wedge Osteotomy System, Arthrex, Inc. (2003) Summary page 1.
- K040907: Arthrex Small Fragment Plates and Screws, Arthrex, Inc. (2004) Summary page 1.
- K052614: Low Profile Plate and Screw System, Arthrex, Inc. (2005) Summary page 1.
- K103705: Low Profile Screws, Arthrex, Inc. (2011) Summary page 1.
- K111253: Arthrex Distal Extremity Plate System, Arthrex, Inc. (2011) Summary page 1.
- K063875: Stryker Foot Plating System, Howmedica Osteonics Corp. (2007) Summary page 2.
- K101962: Mini Maxlock Extreme Plating System, Orthohelix Surgical Designs, Inc. (2010) Summary page 2.
- K120157: Mini Maxlock Extreme Plating System, Orthohelix Surgical Designs, Inc. (2012) Summary page 2.
- K121437: Mini Maxlock Extreme Plating System, Orthohelix Surgical Designs, Inc. (2012) Summary page 2.
- K091614: Osteomed Foot Plating System, Osteomed LP (2009) Summary page 2.

## Most influential descendants
- K170693: Phantom Small Bone Intramedullary Nail System (2017), 9 descendants of its own
- K182307: Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail System (2019), 8 descendants of its own
- K170214: Additive Orthopaedics Locking Lattice Plate (2017), 8 descendants of its own
- K192163: TTC Phantom® Intramedullary Nail System (2020), 6 descendants of its own
- K191782: TTC Phantom Intramedullary Nail System (2019), 6 descendants of its own

## Indications for use
The ParaLock Bone Plates and TUFFNEK Bone Screws of the ParaLock Plating System are indicated for use In stabilization and fixation of fractures or osteotomies: intra and extra articular fractures, joint depression, and multi-fragmentary fractures; revision procedures, joint fusion and reconstruction of small bones of the toes, feet and ankles Including the distal tibia, talus, and calcaneus. The system can be used In both adult and pediatric patients. In addition, the TUFFNEK non-locking, titanium alloy (Ti6AI4V ELI) screws and washers are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair and fracture fixation, appropriate for the size of the device.

Source page: https://510kreport.com/device/K140397
Methodology: https://510kreport.com/methodology