510(k) · Cleared
ClearedDePuy Synthes (USA) 5.0mm / 7.3mm Crimp Positioning Pins – MR Conditional, DePuy Synthes Variable Angle Positioning Pins – MR Conditional, DePuy Synthes Wire Mount – MR Conditional, DePuy Synthes Cerclage Positioning Pin – MR Conditional
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. · JDQ Cerclage, Fixation
Cleared on Jun 21, 2018 as substantially equivalent to K081205 (Synthes (Usa), 2008) and 3 other predicates after a 267-day review. Its family tree reaches back 10 generations to 1996. 2 later devices descend from it.
- Decided
- Jun 21, 2018
- Review
- 267 days
- Class
- Class II
- Product code
- JDQ
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 10 generations to K962616 (1996). 47 ancestors in all, the oldest K890939 (1989). 2 later devices descend from it, 1 citing it directly.
- Root · 10 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 6 generations between
- 3 generations backK083286 Orthopediatrics Pediloc Locking Plate SystemOrthoPediatrics Corp. · 2009 · Recalled
- 2 generations backK120689 Synthes 3.5 MM VA-LCP Proximal Tibia Plate SystemSynthes (USA) Products, LLC · 2012
- 1 generation backK162124 Synthes 4.5mm VA-LCP Curved Condylar Plate System Line Extension…DePuy Synthes · 2017
- This deviceK172975 DePuy Synthes (USA) 5.0mm / 7.3mm Crimp Positioning Pins – MR…Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. · 2018
- Descendant · cites it directly · 1 of its ownK243995 Arthrex Humeral Plating System and Cerclage ButtonArthrex, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK260353 Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage…Arthrex, Inc. · 2026
Show all 10 generations
- Root · 10 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 9 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 8 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
- 7 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 6 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 5 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
- 4 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
- 3 generations backK083286 Orthopediatrics Pediloc Locking Plate SystemOrthoPediatrics Corp. · 2009 · Recalled
- 2 generations backK120689 Synthes 3.5 MM VA-LCP Proximal Tibia Plate SystemSynthes (USA) Products, LLC · 2012
- 1 generation backK162124 Synthes 4.5mm VA-LCP Curved Condylar Plate System Line Extension…DePuy Synthes · 2017
- This deviceK172975 DePuy Synthes (USA) 5.0mm / 7.3mm Crimp Positioning Pins – MR…Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. · 2018
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 |
|---|---|---|---|---|---|
| −10 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −9 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −8 | K023007 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2002 | — |
| −7 | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −6 | K032705 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −5 | K050932 | Distal Volar Radius Anatomical Plate System | Hand Innovations, Inc. | 2005 | 1 |
| −4 | K051735 | Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity | Smith & Nephew, Inc. | 2005 | — |
| −3 | K083286 | Orthopediatrics Pediloc Locking Plate System | OrthoPediatrics Corp. | 2009 | 5 |
| −2 | K120689 | Synthes 3.5 MM VA-LCP Proximal Tibia Plate System | Synthes (USA) Products, LLC | 2012 | — |
| −1 | K162124 | Synthes 4.5mm VA-LCP Curved Condylar Plate System Line Extension, Variable… | DePuy Synthes | 2017 | — |
| 0 (this device) | K172975 | DePuy Synthes (USA) 5.0mm / 7.3mm Crimp Positioning Pins – MR Conditional… | Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. | 2018 | — |
| +1 | K243995 | Arthrex Humeral Plating System and Cerclage Button | Arthrex, Inc. | 2025 | — |
| +2 | K260353 | Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage Button | Arthrex, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 3 | 0 |
| 2000 | 7 | 0 |
| 2001 | 4 | 0 |
| 2003 | 2 | 0 |
| 2004 | 5 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2008 | 4 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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 JDQ? 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 JDQ device
- #1 K261271 Cable-Ready® Cable Grip Systemscore 14.7 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K081205 | Synthes (Usa) 5.0MM/7.3MM Crimp Positioning PinsSummary page 7…PIC Peblaiing Survices (1) 40670 EF . 3DJHRI 510(K) Summary for K081205: Date Prepared: June 20, 2018 1.1. Submitter Primary Contact: Alternate Contact: Suchit… | 2008 |
| * | K162124 | Synthes 4.5mm VA-LCP Curved Condylar Plate System Line Extension, Variable Angle…Summary page 9…Page 3 of 9 . 3DJHRI 510(k) Summary for K162124: Date Prepared: June 20, 2018 1.1. Submitter Primary Contact: Alternate Contact: Suchi… | 2017 |
| * | K953777 | Synthes Wire MountSummary page 11…Page 5 of 9 . 3DJHRI 510(k) Summary for K953777: Date Prepared: June 20, 2018 1.1. Submitter Primary Contact: Alternate Contact: Suchitra… | 1996 |
| * | K992891 | Synthes Cerclage Positioning PinSummary page 13…Page 7 of 9 . 3DJHRI 510(k) Summary for K992891: Date Prepared: June 20, 2018 1.1. Submitter Primary Contact: Alternate Contact: Suchi… | 1999 |
| † | K160553 | DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes Wrist… | 2017 |
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 |
|---|---|---|---|
| K243995 | Arthrex Humeral Plating System and Cerclage Button | 2025 | 1 |
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 22 years and passes through 8 companies; a new generation was cleared every 2.1 years on median.
- 11 of the 47 ancestors have a recall of any class.
- Of its descendants, K243995 (Arthrex, Inc., 2025) has gone furthest, with 1 descendant of its own.
How does its category compare?
All JDQ devicesJDQ Cerclage, Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · JDQ
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JDQ
130in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JDQ
5in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JDQ
84in 2025
MAUDE reports naming product code JDQ, 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 | 1 | — | 0 | 5 |
| 2008 | 2 | — | 2 | 25 |
| 2009 | 2 | — | 0 | 19 |
| 2010 | 0 | — | 2 | 28 |
| 2011 | 6 | 130 | 0 | 30 |
| 2012 | 3 | 134 | 0 | 130 |
| 2013 | 1 | — | 1 | 321 |
| 2014 | 2 | — | 0 | 223 |
| 2015 | 5 | 92 | 1 | 205 |
| 2016 | 4 | 129 | 0 | 224 |
| 2017 | 1 | — | 0 | 138 |
| 2018 | 6 | 101 | 0 | 182 |
| 2019 | 0 | — | 5 | 158 |
| 2020 | 4 | 93 | 0 | 125 |
| 2021 | 0 | — | 0 | 141 |
| 2022 | 2 | — | 0 | 134 |
| 2023 | 3 | 141 | 0 | 98 |
| 2024 | 3 | 130 | 0 | 115 |
| 2025 | 2 | — | 0 | 84 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The DePuy Synthes 5.0mm and 7.3mm Crimp Positioning Pins are intended for use with multifilament cable to augment fracture stabilization with plates used in long bone fixation when the use of screws is contraindicated, as in the presence of intramedullary implants. The 5.0mm Crimp Positioning Pins are designed for use in the 5.0mm locking or 4. 5mm LCP holes of Synthes plates. The 7.3mm Crimp Positioning Pins are designed for use in the 7.3mm locking…
Read the full statement (362 words)
The DePuy Synthes 5.0mm and 7.3mm Crimp Positioning Pins are intended for use with multifilament cable to augment fracture stabilization with plates used in long bone fixation when the use of screws is contraindicated, as in the presence of intramedullary implants.
The 5.0mm Crimp Positioning Pins are designed for use in the 5.0mm locking or 4. 5mm LCP holes of Synthes plates. The 7.3mm Crimp Positioning Pins are designed for use in the 7.3mm locking holes of Synthes plates.
The DePuy Synthes Variable Angle Positioning Pins are intended for use with cerclage multifilament cable to augment fracture stabilization with plates used in long bone fixation, when screw placement would be inhibited, as in the presence of intramedullary implant.
The Variable Angle Positioning Pins are designed for use with Variable Angle LCP plate implants featuring variable angle locking holes that accept 5.0 mm variable angle bone screws.
The DePuy Synthes Wire Mount is intended for use with cerclage wire to augment fracture stabilization with plates used in long bone fixation when the use of screws is contraindicated, as in the presence of intramedullary implants.
The Wire Mount is designed for use in dynamic compression screw holes that accept a 4.5 mm bone screw. The Wire Mount (and cerclage wire) can be used with a variety of plates that include, but are not limited to the following: Dynamic Hip Screw (DHS) Plates. Dynamic Condylar Screw (DCS) Plates, Condylar Buttress Plates, Cobra Head Plates, Hook Plates, 4.5 mm Narrow and Broad Dynamic Compression Plates (DCP), 90° Child and Adolescent Osteotomy Plates, 110-130° Adult Osteotomy Plates, and 95° Condylar and 130° Angle Blade Plates (both including small stature plates).
The DePuy Synthes Cerclage Positioning Pins are intended for use with cerclage monofilament wire and multifilament cable to augment fracture stabilization with plates used in long bone fixation when the use of screws is contraindicated, as in the presence of intramedullary implants.
Cerclage Positioning Pins are designed for use with plates having locking compression or dynamic compression screw holes that accept a 3.5 mm or 4.5 mm bone screws. The Cerclage Positioning Pin (and cerclage wire or cable) can be used with a variety of Synthes plates.
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/K172975 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172975: DePuy Synthes (USA) 5.0mm / 7.3mm Crimp Positioning Pins – MR Conditional, DePuy Synthes Variable Angle Positioning Pins – MR Conditional, DePuy Synthes Wire Mount – MR Conditional, DePuy Synthes Cerclage Positioning Pin – MR Conditional.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172975
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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