# K152256: RECON system- Grubber Lapidus-, Platar Lapidus-, Tarsalis Plates and Screws

- Pathway: 510(k) (Traditional)
- Applicant: Normed Medizin-Technik GmbH
- Decided: Nov 5, 2015 after 87 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.
6 later devices descend from it; 1 cites it directly.
0 of 7 devices 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
- K050645: Cordis Amiia .014 Pta Balloon Catheter, Cordis Corp. (2005). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
- K092017: Pivotec Lumbar Interbody Fusion Device (Lifd), Captiva Spine, Inc. (2009). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
- K091940: Magpro, Models R30 with Magoption, X100, X100 with Magoption, Tonica Elektronik A/S (2010). Not matched in our reading of the summary (scans can blur digits), so it is 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
- K101475: Compress Anti-Rotation Spindles, Biomet Manufacturing Corp (2010). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
- K131886: RECON System-MP-Plates. Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K161448: Footmotion Plating System (2016), 5 descendants of its own
- K171510: Footmotion Plating System (2017), 1 descendant of its own
- K170843: Alians Fragment Specific (2017), 1 descendant of its own
- K221395: Footmotion Plating System (2022), 0 descendants of its own
- K213214: Xpert Wrist (2021), 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. Gruber Lapidus The Gruber Lapidus Plates 2.7 combined with the Standard/Locking/ MiniCAN screws 2.7 are indicated for TMT I joint arthrodesis with cuneiforme transfixation for correction of hallux valgus deformity. Plantar Lapidus The Plantar Lapidus Plates 2.7 combined with the Standard/Locking Screws 2.7 and the MiniCAN screws 3.5 are indicated for TMT I joint arthrodesis. Tarsalis The Tarsalis Plates 2.7 combined with the Standard/Locking Screws 2.7 are indicated for Lisfranc fusions and fracture fixation of the forefoot and midfoot.

Source page: https://510kreport.com/device/K152256
Methodology: https://510kreport.com/methodology