# K152312: RECON system-V-TEK-IVP Plates and Screws

- Pathway: 510(k) (Traditional)
- Applicant: Normed Medizin-Technik GmbH
- Decided: Oct 30, 2015 after 74 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K962616 (1996). 185 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 188 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010321: Modular Foot System - 2.7 MM Module, Synthes (Usa) (2001) 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.
- K143066: Zimmer Plates and Screws (ZPS) - Non Sterile Plate Line Extensions, Sterile/Non-Sterile ZPS / Screws and Washers, Zimmer, Inc. (2014) Summary page 5.
- 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.
- K120157: Mini Maxlock Extreme Plating System, Orthohelix Surgical Designs, Inc. (2012) Summary page 5.
- K151407: RECON system, Normed Medizin-Technik GmbH (2015) Summary page 5.

## Most influential descendants
- 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

## Recalls of this device
- Apr 8, 2019 · Class II · Z-1449-2019: An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
- Apr 8, 2019 · Class II · Z-1448-2019: An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
- Apr 8, 2019 · Class II · Z-1445-2019: An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
- Apr 8, 2019 · Class II · Z-1447-2019: An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

## Indications for use
The implants are intended to support normal bone healing for osteotomies, fractures, non-unions and reconstructions. The RECON system consists of various system components and it is indicated for the treatment of fracture fixation, non-unions, joint decompression and fusion, osteotomies, reconstruction or arthrodeses of 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/K152312
Methodology: https://510kreport.com/methodology