# K151407: RECON system

- Pathway: 510(k) (Traditional)
- Applicant: Normed Medizin-Technik GmbH
- Decided: Aug 12, 2015 after 78 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: 11 generations back to K962616 (1996). 176 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 181 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143165: Herbert/Whipple Bone Screw System, Herbert/Whipple Bone Screw System, Herbert Cannulated Bone Screw System, Herbert Mini Bone Screw, Zimmer, Inc. (2015) Summary page 5.
- K063303: Universal Locking System, 2.7MM Plates & Screws, Zimmer, Inc. (2006) Summary page 5.
- K060710: Universal Locking System, 3.5MM Plates and Screws-4936 Plates,4835 Screws, Zimmer, Inc. (2006) Summary page 5.
- K022325: Normed Titanium Osteotomy Plating System, Osteomedics, Inc. (2002) Summary page 5.
- K022231: Normed Distal Radius Reconstruction System, Osteomedics, Inc. (2002) Summary page 5.
- K143066: Zimmer Plates and Screws (ZPS) - Non Sterile Plate Line Extensions, Sterile/Non-Sterile ZPS / Screws and Washers, Zimmer, Inc. (2014) Summary page 5.
- K090675: Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories, Smith & Nephew, Inc. (2009) Summary page 5.
- K121651: Ortholoc 3DI Midfoot/Flatfoot System, Wrightmedicaltechnologyinc (2012) Summary page 5.
- K141784: Ortho Solutions Ultos Plating System, Ortho Solutions Limited (2014) Summary page 5.
- K111678: Ortho Solutions Extremity Fixation Implants for Osteosysnthesis, Ortho Solutions Limited (2012) Summary page 5.

## Most influential descendants
- K152312: RECON system-V-TEK-IVP Plates and Screws (2015), 2 descendants of its own
- K202657: Javelin Tailor's Bunion Fixation System (2020), 1 descendant of its own
- K260291: Vortex5 Tailor's Bunion Correction System (2026), 0 descendants of its own
- K151708: RECON system - Compression Screws (2016), 0 descendants of its own

## Indications for use
The implants are intended to support normal bone healing for osteotomies, fractures, and reconstructions. The RECON system consists of various system components and it is indicated for the treatment of fracture fixation, joint decompression and fusion, reconstruction or arthrodeses of small bones. The system can be used in both adult and pediatric patients. Additional information is provided in the corresponding surgical techniques.

Source page: https://510kreport.com/device/K151407
Methodology: https://510kreport.com/methodology