510(k) · Cleared
ClearedRECON system- Grubber Lapidus-, Platar Lapidus-, Tarsalis Plates and Screws
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Normed Medizin-Technik GmbH · HRS Plate, Fixation, Bone
Cleared on Nov 5, 2015 after an 87-day review. The summary cites 6 numbers, none of which could be confirmed as its predicate (see the table below). 6 later devices descend from it.
- Decided
- Nov 5, 2015
- Review
- 87 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 6
6 later devices descend from it, 1 citing it directly.
- This deviceK152256 RECON system- Grubber Lapidus-, Platar Lapidus-, Tarsalis Plates and…Normed Medizin-Technik GmbH · 2015
- Descendant · cites it directly · 5 of its ownK161448 Footmotion Plating SystemNewclip Technics · 2016
- Descendant · 2 generations on · 1 of its ownK171510 Footmotion Plating SystemNewclip Technics · 2017
- Descendant · 2 generations on · 1 of its ownK170843 Alians Fragment SpecificNewclip Technics · 2017
- Descendant · 2 generations on · 0 of its ownK221395 Footmotion Plating SystemNewclip Technics · 2022
- Descendant · 3 generations on · 0 of its ownK213214 Xpert WristNewclip Technics · 2021
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K161448Footmotion Plating SystemNewclip Technics · 2016 · cites it directly5descendants
- K171510Footmotion Plating SystemNewclip Technics · 2017 · 2 generations on1descendant
- K170843Alians Fragment SpecificNewclip Technics · 2017 · 2 generations on1descendant
- K221395Footmotion Plating SystemNewclip Technics · 2022 · 2 generations on0descendants
- K213214Xpert WristNewclip Technics · 2021 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K152256 | RECON system- Grubber Lapidus-, Platar Lapidus-, Tarsalis Plates and Screws | Normed Medizin-Technik GmbH | 2015 | — |
| +1 | K161448 | Footmotion Plating System | Newclip Technics | 2016 | — |
| +2 | K171510 | Footmotion Plating System | Newclip Technics | 2017 | — |
| +2 | K170843 | Alians Fragment Specific | Newclip Technics | 2017 | — |
| +2 | K221395 | Footmotion Plating System | Newclip Technics | 2022 | — |
| +3 | K213214 | Xpert Wrist | Newclip Technics | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 3 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HRS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new HRS device
- #1 K222465 Tyber Medical Anatomical Plating Systemscore 27.5 · 16 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (6)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K050645 | FDA’s K050645 is Cordis Amiia .014 Pta Balloon Catheter Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2005 |
| Kept off the family tree | K092017 | FDA’s K092017 is Pivotec Lumbar Interbody Fusion Device (Lifd) Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2009 |
| Kept off the family tree | K091940 | FDA’s K091940 is Magpro, Models R30 with Magoption, X100, X100 with Magoption Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2010 |
| Kept off the family tree | K082636 | FDA’s K082636 is TXRX 15CH Knee Coil (1.5T and 3T), TXRX CP Extremity Coil 3T Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2008 |
| Kept off the family tree | K101475 | FDA’s K101475 is Compress Anti-Rotation Spindles Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2010 |
| 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 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K161448 | Footmotion Plating System | 2016 | 5 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K161448 (Newclip Technics, 2016) has gone furthest, with 5 descendants of its own.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · HRS
54in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HRS
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HRS
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HRS
2,306in 2025
MAUDE reports naming product code HRS, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 35 | 63 | 2 | 339 |
| 2008 | 35 | 87 | 11 | 311 |
| 2009 | 47 | 85 | 3 | 435 |
| 2010 | 49 | 100 | 16 | 491 |
| 2011 | 43 | 88 | 5 | 773 |
| 2012 | 59 | 106 | 4 | 1,663 |
| 2013 | 56 | 89 | 11 | 2,643 |
| 2014 | 76 | 57 | 0 | 2,413 |
| 2015 | 56 | 97 | 7 | 3,095 |
| 2016 | 44 | 109 | 5 | 2,276 |
| 2017 | 57 | 122 | 3 | 2,220 |
| 2018 | 40 | 116 | 2 | 2,663 |
| 2019 | 46 | 89 | 25 | 3,359 |
| 2020 | 48 | 88 | 1 | 2,790 |
| 2021 | 40 | 87 | 9 | 2,442 |
| 2022 | 47 | 144 | 3 | 1,700 |
| 2023 | 40 | 120 | 1 | 2,049 |
| 2024 | 54 | 96 | 0 | 1,849 |
| 2025 | 54 | 90 | 1 | 2,306 |
| 2026 | 51 | 82 | 3 | — |
What is it indicated for?
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…
Read the full statement (141 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152256 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152256: RECON system- Grubber Lapidus-, Platar Lapidus-, Tarsalis Plates and Screws.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152256
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026