# K152142: RECON system - MPJ-Plates

- Pathway: 510(k) (Traditional)
- Applicant: Normed Medizin-Technik GmbH
- Decided: Sep 16, 2015 after 44 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites 6 numbers, none of which could be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K082636: TXRX 15CH Knee Coil (1.5T and 3T), TXRX CP Extremity Coil 3T, Quality Electrodynamics (2008). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
- K070348: Universal Locking Plate System 2.4, Plates and Screws. Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
- K060707: Aesculap Bipolar Acetabular Cup, Aesculap, Inc. (2006). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
- K061918: Foley Catheters with Temperature Probe, GE Healthcare (2006). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
- K071117: Modification to Pinnacle Constrained Acetabular Liners, DePuy Orthopaedics, Inc. (2007). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
- K130701: RECON System. Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
The implants are intended to support normal bone healing for osteotomies, fractures, and reconstructions. The RECON system – MPJ Plates 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 for adult patients. Additional information is provided in the corresponding surgical techniques. The MP-Joint Fusion Plates 2.7 combined with the Standard/Locking Screws 2.7 are indicated for the arthrodesis of the first metatarso-phalangeal joint. • Plate size S is indicated for standard MP-Joint fusions. • Plate Sizes M/L are indicated for standard MP-Joint fusion and interpositioning / revision fusions with bone graft (f.e. for revision of Keller-Brandes). The Universal Reconstruction Plates 2.7 combined with Standard/Locking Screws 2.7 are indicated for revision of MP-joint fusion and for reconstruction procedures in forefoot and midfoot. The docPrice Revision Plates 2.7/3.5 combined with the Standard/Locking Screws 2.7/3.5 are indicated for MTP I lengthening osteotomy and/or arthrodesis, especially indicated for cases of Keller-Brandes revisions, revisions after MTP I prosthesis and lengthening of short first toe.

Source page: https://510kreport.com/device/K152142
Methodology: https://510kreport.com/methodology