510(k) · Cleared
Recalled · Class II · 2019RECON system-V-TEK-IVP 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 Oct 30, 2015 as substantially equivalent to K010321 (Synthes (Usa), 2001) and 6 other predicates after a 74-day review. Its family tree reaches back 12 generations to 1996. 2 later devices descend from it. It has been recalled 4 times.
- Decided
- Oct 30, 2015
- Review
- 74 days
- Class
- Class II
- Product code
- HRS
- Recalls
- 4
- Predicates
- 7
Its longest line of descent runs back 12 generations to K962616 (1996). 185 ancestors in all, the oldest K792022 (1979). 2 later devices descend from it, 1 citing it directly.
- Root · 12 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 8 generations between
- 3 generations backK100776 Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa) · 2010
- 2 generations backK141784 Ortho Solutions Ultos Plating SystemOrtho Solutions Limited · 2014 · Recalled
- 1 generation backK151407 RECON systemNormed Medizin-Technik GmbH · 2015
- This deviceK152312 RECON system-V-TEK-IVP Plates and ScrewsNormed Medizin-Technik GmbH · 2015
- Descendant · cites it directly · 1 of its ownK202657 Javelin Tailor's Bunion Fixation SystemNvision Biomedical Technologies, Inc. · 2020
- Descendant · 2 generations on · 0 of its ownK260291 Vortex5 Tailor's Bunion Correction SystemNvision Biomedical Technologies, Inc. · 2026
Show all 12 generations
- Root · 12 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 11 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 10 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
- 9 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 8 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 7 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
- 6 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
- 5 generations backK071563 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007
- 4 generations backK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
- 3 generations backK100776 Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa) · 2010
- 2 generations backK141784 Ortho Solutions Ultos Plating SystemOrtho Solutions Limited · 2014 · Recalled
- 1 generation backK151407 RECON systemNormed Medizin-Technik GmbH · 2015
- This deviceK152312 RECON system-V-TEK-IVP Plates and ScrewsNormed Medizin-Technik GmbH · 2015
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −11 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −10 | K023007 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2002 | — |
| −9 | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −8 | K032705 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −7 | K050932 | Distal Volar Radius Anatomical Plate System | Hand Innovations, Inc. | 2005 | 1 |
| −6 | K051735 | Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity | Smith & Nephew, Inc. | 2005 | — |
| −5 | K071563 | Peri-Loc Periarticular Locked Plating System | Smith & Nephew, Inc. | 2007 | — |
| −4 | K090675 | Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories | Smith & Nephew, Inc. | 2009 | — |
| −3 | K100776 | Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot System | Synthes (Usa) | 2010 | — |
| −2 | K141784 | Ortho Solutions Ultos Plating System | Ortho Solutions Limited | 2014 | 2 |
| −1 | K151407 | RECON system | Normed Medizin-Technik GmbH | 2015 | — |
| 0 (this device) | K152312 | RECON system-V-TEK-IVP Plates and Screws | Normed Medizin-Technik GmbH | 2015 | — |
| +1 | K202657 | Javelin Tailor's Bunion Fixation System | Nvision Biomedical Technologies, Inc. | 2020 | — |
| +2 | K260291 | Vortex5 Tailor's Bunion Correction System | Nvision Biomedical Technologies, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1981 | 1 | 0 |
| 1987 | 1 | 0 |
| 1989 | 4 | 0 |
| 1990 | 3 | 0 |
| 1991 | 1 | 0 |
| 1992 | 6 | 0 |
| 1993 | 3 | 0 |
| 1994 | 6 | 0 |
| 1995 | 5 | 0 |
| 1996 | 12 | 0 |
| 1997 | 2 | 0 |
| 1998 | 4 | 0 |
| 1999 | 8 | 0 |
| 2000 | 10 | 0 |
| 2001 | 13 | 0 |
| 2002 | 12 | 0 |
| 2003 | 5 | 0 |
| 2004 | 6 | 0 |
| 2005 | 12 | 0 |
| 2006 | 15 | 0 |
| 2007 | 5 | 0 |
| 2008 | 9 | 0 |
| 2009 | 8 | 0 |
| 2010 | 9 | 0 |
| 2011 | 4 | 0 |
| 2012 | 4 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2026 | 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? (7)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K010321 | Modular Foot System - 2.7 MM ModuleSummary page 5…V-TEK-IVP Plates and Screws 4. Legally Marketed Predicate Device K010321 – Modular Foot System – 2.7 mm Module, manufactured by Synthes Inc., cleared May 2, 2001 K063303 – Univ… | 2001 |
| * | K063303 | Universal Locking System, 2.7MM Plates & ScrewsSummary page 5…4. Legally Marketed Predicate Device K010321 – Modular Foot System – 2.7 mm Module, manufactured by Synthes Inc., cleared May 2, 2001 K063303 – Universal Locking Plate System 2.7, Plates and Screws, manufactured by Zimmer Inc., cleared November 22, 2006… | 2006 |
| * | K060710 | Universal Locking System, 3.5MM Plates and Screws-4936 Plates,4835 ScrewsSummary page 5…leared May 2, 2001 K063303 – Universal Locking Plate System 2.7, Plates and Screws, manufactured by Zimmer Inc., cleared November 22, 2006 K060710 – Universal Locking Plate System 3.5, Plates and Screws manufactured by Zimmer Inc., cleared April 26, 2006… | 2006 |
| * | K143066 | Zimmer Plates and Screws (ZPS) - Non Sterile Plate Line Extensions, Sterile/Non-Sterile…Summary page 5…ed November 22, 2006 K060710 – Universal Locking Plate System 3.5, Plates and Screws manufactured by Zimmer Inc., cleared April 26, 2006 K143066 – Zimmer Plates and Screws System (ZPS) – Non-sterile ZPS Plate Line Extensions, Sterile/Non-sterile ZPS Screw… | 2014 |
| * | K143165 | Herbert/Whipple Bone Screw System, Herbert/Whipple Bone Screw System, Herbert Cannulated…Summary page 5…– Non-sterile ZPS Plate Line Extensions, Sterile/Non-sterile ZPS Screws and Washers, manufactured by Zimmer Inc., cleared November 28, 2014 K143165 – Herbert/Whipple Bone Screw System, Herbert Bone Screw, Herbert Cannulated Bone Screw System, and Herbert Mini… | 2015 |
| * | K120157 | Mini Maxlock Extreme Plating SystemSummary page 5…Herbert Bone Screw, Herbert Cannulated Bone Screw System, and Herbert Mini Bone Screw, manufactured by Zimmer Inc., cleared March 31, 2015 K120157 – Mini Max Lock Extreme Plating System, manufactured by OrthoHelix Designs Inc., cleared April 10, 2012 K… | 2012 |
| * | K151407 | RECON systemSummary page 5…, cleared March 31, 2015 K120157 – Mini Max Lock Extreme Plating System, manufactured by OrthoHelix Designs Inc., cleared April 10, 2012 K151407 – Recon System, manufactured by Normed Medizin-Technik GmbH, cleared August 12, 2015… | 2015 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K202657 | Javelin Tailor's Bunion Fixation System | 2020 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 8, 2019 | Class II | Z-1449-2019 | Under Investigation by firm | 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 | Under Investigation by firm | 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 | Under Investigation by firm | 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 | Under Investigation by firm | An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 6 companies; a new generation was cleared every 1.6 years on median.
- 40 of the 185 ancestors have a recall of any class.
- Of its descendants, K202657 (Nvision Biomedical Technologies, Inc., 2020) has gone furthest, with 1 descendant of its own.
- 8 other devices also cite its predicate K010321.
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, 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152312 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152312: RECON system-V-TEK-IVP 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/K152312
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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