510(k) · Cleared
ClearedRECON system - Compression Screws
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Normed Medizin-Technik GmbH · HWC Screw, Fixation, Bone
Cleared on Mar 2, 2016 as substantially equivalent to K143165 (Zimmer, Inc., 2015) and 7 other predicates after a 252-day review. Its family tree reaches back 12 generations to 1996.
- Decided
- Mar 2, 2016
- Review
- 252 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 8
Its longest line of descent runs back 12 generations to K962616 (1996). 185 ancestors in all, the oldest K792022 (1979). No later device cites it as a predicate yet.
- 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 deviceK151708 RECON system - Compression ScrewsNormed Medizin-Technik GmbH · 2016
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 deviceK151708 RECON system - Compression ScrewsNormed Medizin-Technik GmbH · 2016
View 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) | K151708 | RECON system - Compression Screws | Normed Medizin-Technik GmbH | 2016 | — |
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 | 13 | 0 |
| 1997 | 2 | 0 |
| 1998 | 4 | 0 |
| 1999 | 8 | 0 |
| 2000 | 11 | 0 |
| 2001 | 13 | 0 |
| 2002 | 12 | 0 |
| 2003 | 8 | 0 |
| 2004 | 7 | 0 |
| 2005 | 11 | 0 |
| 2006 | 16 | 0 |
| 2007 | 5 | 0 |
| 2008 | 7 | 0 |
| 2009 | 8 | 0 |
| 2010 | 7 | 0 |
| 2011 | 3 | 0 |
| 2012 | 3 | 0 |
| 2014 | 2 | 0 |
| 2015 | 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 HWC? 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 HWC device
- #1 K203011 Monster Screw Systemscore 22.2 · 14 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (8)
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 |
|---|---|---|---|
| * | K143165 | Herbert/Whipple Bone Screw System, Herbert/Whipple Bone Screw System, Herbert Cannulated…Summary page 5…Notification Traditional RECON system-Compression 510(k) screws 4. Legally Marketed Predicate Device K143165 - Herbert/Whipple Bone Screw System, Herbert Bone Screw, Herbert Cannulated Bone Screw System, and… | 2015 |
| * | K061211 | NCB Plating System, Proximal Tibia PlatesSummary page 5…Device K143165 - Herbert/Whipple Bone Screw System, Herbert Bone Screw, Herbert Cannulated Bone Screw System, and Herbert Mini Bone Screw K061211 - NCB Plating System K042695 - NCB Plating System K063303/ - Zimmer Universal Locking System (ULS)… | 2006 |
| * | K042695 | NCB Plating SystemSummary page 5…ple Bone Screw System, Herbert Bone Screw, Herbert Cannulated Bone Screw System, and Herbert Mini Bone Screw K061211 - NCB Plating System K042695 - NCB Plating System K063303/ - Zimmer Universal Locking System (ULS) Plates and Screws K060710 K032634… | 2004 |
| * | K063303 | Universal Locking System, 2.7MM Plates & ScrewsSummary page 5…w, Herbert Cannulated Bone Screw System, and Herbert Mini Bone Screw K061211 - NCB Plating System K042695 - NCB Plating System K063303/ - Zimmer Universal Locking System (ULS) Plates and Screws K060710 K032634 - Normed Compression Bone Screw Sy… | 2006 |
| * | K060710 | Universal Locking System, 3.5MM Plates and Screws-4936 Plates,4835 ScrewsSummary page 5…i Bone Screw K061211 - NCB Plating System K042695 - NCB Plating System K063303/ - Zimmer Universal Locking System (ULS) Plates and Screws K060710 K032634 - Normed Compression Bone Screw System K022324 - Normed Titanium Osteotomy Plating System K151407… | 2006 |
| * | K032634 | Normed Compression Bone Screw SystemSummary page 5…rew K061211 - NCB Plating System K042695 - NCB Plating System K063303/ - Zimmer Universal Locking System (ULS) Plates and Screws K060710 K032634 - Normed Compression Bone Screw System K022324 - Normed Titanium Osteotomy Plating System K151407 -… | 2003 |
| * | K022324 | Normed Titanium Calcaneus Plating with Locking Screw SystemSummary page 5…- NCB Plating System K063303/ - Zimmer Universal Locking System (ULS) Plates and Screws K060710 K032634 - Normed Compression Bone Screw System K022324 - Normed Titanium Osteotomy Plating System K151407 - Normed RECON System 5. Device Description The RECON… | 2002 |
| * | K151407 | RECON system Cleared while this submission was under review Summary page 5…l Locking System (ULS) Plates and Screws K060710 K032634 - Normed Compression Bone Screw System K022324 - Normed Titanium Osteotomy Plating System K151407 - Normed RECON System 5. Device Description The RECON system -compression screws are intended for internal fracture… | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 20 years and passes through 6 companies; a new generation was cleared every 1.6 years on median.
- 39 of the 185 ancestors have a recall of any class.
- 4 other devices also cite its predicate K143165.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · HWC
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HWC
111in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HWC
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HWC
2,893in 2025
MAUDE reports naming product code HWC, 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 | 77 | 25 | 669 |
| 2008 | 33 | 76 | 33 | 660 |
| 2009 | 27 | 113 | 29 | 651 |
| 2010 | 23 | 110 | 7 | 765 |
| 2011 | 35 | 88 | 12 | 1,104 |
| 2012 | 20 | 99 | 30 | 3,339 |
| 2013 | 25 | 90 | 14 | 3,850 |
| 2014 | 31 | 88 | 2 | 2,549 |
| 2015 | 41 | 85 | 5 | 2,711 |
| 2016 | 26 | 131 | 4 | 2,285 |
| 2017 | 40 | 127 | 4 | 2,561 |
| 2018 | 20 | 106 | 1 | 3,662 |
| 2019 | 30 | 108 | 5 | 5,463 |
| 2020 | 28 | 75 | 4 | 4,820 |
| 2021 | 26 | 84 | 2 | 4,446 |
| 2022 | 26 | 167 | 13 | 3,934 |
| 2023 | 24 | 104 | 0 | 3,718 |
| 2024 | 17 | 90 | 0 | 3,575 |
| 2025 | 15 | 111 | 1 | 2,893 |
| 2026 | 21 | 125 | 2 | — |
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 adult patients. Additional information is provided in the corresponding surgical techniques.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K151708 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151708: RECON system - Compression Screws.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151708
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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