# K151708: RECON system - Compression Screws

- Pathway: 510(k) (Traditional)
- Applicant: Normed Medizin-Technik GmbH
- Decided: Mar 2, 2016 after 252 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- 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 K962616 (1996). 185 ancestors in all.
No later device cites it as a predicate yet.
0 of 186 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.
- K061211: NCB Plating System, Proximal Tibia Plates, Zimmer GmbH (2006) Summary page 5.
- K042695: NCB Plating System, Zimmer GmbH (2004) 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.
- K032634: Normed Compression Bone Screw System, Noviace Corporation (2003) Summary page 5.
- K022324: Normed Titanium Calcaneus Plating with Locking Screw System, Osteomedics, Inc. (2002) Summary page 5.
- K151407: RECON system, Normed Medizin-Technik GmbH (2015). Cleared while this submission was under review Summary page 5.

## 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 adult patients. Additional information is provided in the corresponding surgical techniques.

Source page: https://510kreport.com/device/K151708
Methodology: https://510kreport.com/methodology