510(k) · Cleared
ClearedY3 Proximal Femoral Plate System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pega Medical, Inc. · HRS Plate, Fixation, Bone
Cleared on Mar 16, 2017 as substantially equivalent to K120772 (Zimmer GmbH, 2012) and 1 other predicate after a 139-day review. Its family tree reaches back 6 generations to 1998.
- Decided
- Mar 16, 2017
- Review
- 139 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K981372 (1998). 27 ancestors in all, the oldest K935481 (1994). No later device cites it as a predicate yet.
- Root · 6 generations backK981372 Synthes 3.0 MM PC-Fix SystemSynthes (Usa) · 1998
- 5 generations backK991407 Synthes Locking Calcaneal PlatesSynthes (Usa) · 1999
- 4 generations backK033669 Smith & Nephew Locking Bone Plate System (Locking Bone Plates and…Smith & Nephew, Inc. · 2003 · Recalled
- 3 generations backK082807 Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with…Synthes (Usa) · 2008
- 2 generations backK100111 NCB Periprosthetic Femur Polyaxial Locking Plate SystemZimmer, Inc. · 2010 · Recalled
- 1 generation backK120772 NCB Periprosthetic Trochanter Plates and Screws, NCB Cable Button…Zimmer GmbH · 2012 · Recalled
- This deviceK163003 Y3 Proximal Femoral Plate SystemPega Medical, Inc. · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K981372 | Synthes 3.0 MM PC-Fix System | Synthes (Usa) | 1998 | — |
| −5 | K991407 | Synthes Locking Calcaneal Plates | Synthes (Usa) | 1999 | — |
| −4 | K033669 | Smith & Nephew Locking Bone Plate System (Locking Bone Plates and Screws) | Smith & Nephew, Inc. | 2003 | 1 |
| −3 | K082807 | Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with Expanded… | Synthes (Usa) | 2008 | — |
| −2 | K100111 | NCB Periprosthetic Femur Polyaxial Locking Plate System | Zimmer, Inc. | 2010 | 2 |
| −1 | K120772 | NCB Periprosthetic Trochanter Plates and Screws, NCB Cable Button for NCB… | Zimmer GmbH | 2012 | 2 |
| 0 (this device) | K163003 | Y3 Proximal Femoral Plate System | Pega Medical, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1996 | 3 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 3 | 0 |
| 2000 | 6 | 0 |
| 2001 | 2 | 0 |
| 2004 | 2 | 0 |
| 2009 | 1 | 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 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? (2)
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 |
|---|---|---|---|
| * | K120772 | NCB Periprosthetic Trochanter Plates and Screws, NCB Cable Button for NCB Oplyaxial…Summary page 5…Plate System Marketed by Zimmer, GmbH Zimmer, Inc. Pega Medical Inc. FDA 510(k) K120772 K151907 K160545 number Summary of Technologies: The technological characteristics of… | 2012 |
| * | K151907 | Cable-Ready® Cable Grip System: Cable-Ready® GTR System, Cable-Ready® 1.8mm Cerclage…Summary page 5…Zimmer, GmbH Zimmer, Inc. Pega Medical Inc. FDA 510(k) K120772 K151907 K160545 number Summary of Technologies: The technological characteristics of the Y3 Proximal Femoral Plate Syst… | 2015 |
| † | K160545 | Gap Endo-Exo Medullary System | 2016 |
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 19 years and passes through 5 companies; a new generation was cleared every 4.5 years on median.
- 7 of the 27 ancestors have a recall of any class.
- 4 other devices also cite its predicate K120772.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 Y3 Proximal Femoral Plate System is intended for the temporary internal fixation and stabilization of fractures and osteotomies of the greater trochanter or of the proximal femur. It is indicated for the following:
* Re-attachment of the greater trochanter following osteotomy in THA
* Trochanteric and intertrochanteric fractures
* Extended trochanteric osteotomy
* Periprosthetic femoral fractures
* Comminuted fractures
* Mal-unions and non-unions
* Fractures in osteopenic bone
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/K163003 · printed Nov 3, 2026
Cite this page
510(k) Report. “K163003: Y3 Proximal Femoral Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K163003
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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