510(k) · Cleared
Recalled · 2010Polyax Locked Plating System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
DePuy Orthopaedics, Inc. · HRS Plate, Fixation, Bone
Cleared on May 12, 2006 as substantially equivalent to K003235 (DePuy Orthopaedics, Inc., 2000) and 1 other predicate after a 35-day review. Its family tree reaches back 3 generations to 1996. 10 later devices descend from it. It has been recalled 10 times.
- Decided
- May 12, 2006
- Review
- 35 days
- Class
- Class II
- Product code
- HRS
- Recalls
- 10
- Predicates
- 2
Its longest line of descent runs back 3 generations to K962616 (1996). 6 ancestors in all. 10 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 2 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 1 generation backK040593 Periarticular Locking Plates and Screws, 2358, 2359 SeriesZimmer, Inc. · 2004 · Recalled
- This deviceK060969 Polyax Locked Plating SystemDePuy Orthopaedics, Inc. · 2006
- Descendant · cites it directly · 4 of its ownK143496 Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd. · 2015
- Descendant · cites it directly · 4 of its ownK072423 4.5MM Locking Broad & Narrow Compression Plates, 4.5MM & 5.5MM…DePuy Orthopaedics, Inc. · 2007
- Descendant · 2 generations on · 3 of its ownK170401 Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd. · 2017
- Descendant · 2 generations on · 3 of its ownK103408 Posterior Lateral PlatesDePuy Orthopaedics, Inc. · 2010
- Descendant · 2 generations on · 1 of its ownK182015 Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd. · 2018
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K143496Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd. · 2015 · cites it directly4descendants
- K0724234.5MM Locking Broad & Narrow Compression Plates, 4.5MM & 5.5MM Cortical & Cancellous…DePuy Orthopaedics, Inc. · 2007 · cites it directly4descendants
- K170401Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd. · 2017 · 2 generations on3descendants
- K103408Posterior Lateral PlatesDePuy Orthopaedics, Inc. · 2010 · 2 generations on3descendants
- K182015Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd. · 2018 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −2 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −1 | K040593 | Periarticular Locking Plates and Screws, 2358, 2359 Series | Zimmer, Inc. | 2004 | 2 |
| 0 (this device) | K060969 | Polyax Locked Plating System | DePuy Orthopaedics, Inc. | 2006 | — |
| +1 | K143496 | Piccolo Composite Plate System | CarboFix Orthopedics, Ltd. | 2015 | — |
| +1 | K072423 | 4.5MM Locking Broad & Narrow Compression Plates, 4.5MM & 5.5MM Cortical &… | DePuy Orthopaedics, Inc. | 2007 | — |
| +2 | K170401 | Piccolo Composite® Plate System | CarboFix Orthopedics, Ltd. | 2017 | — |
| +2 | K103408 | Posterior Lateral Plates | DePuy Orthopaedics, Inc. | 2010 | — |
| +2 | K182015 | Piccolo Composite® Plate System | CarboFix Orthopedics, Ltd. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K003235 | PE.R.I. II Knee Fracture SystemSummary page 1…VICE PRODUCT CODE: 87 HRS SUBSTANTIALLY EQUIVALENT DePuy POLYAX Knee Fracture System, DEVICES: K003235, cleared on November 6, 2000 Zimmer Periarticular Locking Plates,… | 2000 |
| * | K040593 | Periarticular Locking Plates and Screws, 2358, 2359 SeriesSummary page 1…K003235, cleared on November 6, 2000 Zimmer Periarticular Locking Plates, K040593, cleared on April 12, 2004 DEVICE DESCRIPTION: The DePuy POLYAX Locked Plating System is comprised of anatomically contoured, mu… | 2004 |
What descends from it? (10)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 1, 2010 | Not classified | Z-1586-2011 | Other | The firm determined that the 8.0 mm hole threads in the PolyAx Distal Femoral Locking Plate were incorrectly manufactured, which prevents the mating screw from locking in place. The screw should lock with the plate, instead the screw… |
| Nov 1, 2010 | Not classified | Z-1580-2011 | Other | The firm determined that the 8.0 mm hole threads in the PolyAx Distal Femoral Locking Plate were incorrectly manufactured, which prevents the mating screw from locking in place. The screw should lock with the plate, instead the screw… |
| Nov 1, 2010 | Not classified | Z-1587-2011 | Other | The firm determined that the 8.0 mm hole threads in the PolyAx Distal Femoral Locking Plate were incorrectly manufactured, which prevents the mating screw from locking in place. The screw should lock with the plate, instead the screw… |
| Nov 1, 2010 | Not classified | Z-1581-2011 | Other | The firm determined that the 8.0 mm hole threads in the PolyAx Distal Femoral Locking Plate were incorrectly manufactured, which prevents the mating screw from locking in place. The screw should lock with the plate, instead the screw… |
| Nov 1, 2010 | Not classified | Z-1578-2011 | Other | The firm determined that the 8.0 mm hole threads in the PolyAx Distal Femoral Locking Plate were incorrectly manufactured, which prevents the mating screw from locking in place. The screw should lock with the plate, instead the screw… |
| Nov 1, 2010 | Not classified | Z-1583-2011 | Other | The firm determined that the 8.0 mm hole threads in the PolyAx Distal Femoral Locking Plate were incorrectly manufactured, which prevents the mating screw from locking in place. The screw should lock with the plate, instead the screw… |
| Nov 1, 2010 | Not classified | Z-1585-2011 | Other | The firm determined that the 8.0 mm hole threads in the PolyAx Distal Femoral Locking Plate were incorrectly manufactured, which prevents the mating screw from locking in place. The screw should lock with the plate, instead the screw… |
| Nov 1, 2010 | Not classified | Z-1584-2011 | Other | The firm determined that the 8.0 mm hole threads in the PolyAx Distal Femoral Locking Plate were incorrectly manufactured, which prevents the mating screw from locking in place. The screw should lock with the plate, instead the screw… |
| Nov 1, 2010 | Not classified | Z-1579-2011 | Other | The firm determined that the 8.0 mm hole threads in the PolyAx Distal Femoral Locking Plate were incorrectly manufactured, which prevents the mating screw from locking in place. The screw should lock with the plate, instead the screw… |
| Nov 1, 2010 | Not classified | Z-1582-2011 | Other | The firm determined that the 8.0 mm hole threads in the PolyAx Distal Femoral Locking Plate were incorrectly manufactured, which prevents the mating screw from locking in place. The screw should lock with the plate, instead the screw… |
The 5 latest of 10 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 10 years and passes through 4 companies; a new generation was cleared every 2.1 years on median.
- 2 of the 6 ancestors have a recall of any class.
- Of its descendants, K143496 (CarboFix Orthopedics, Ltd., 2015) has gone furthest, with 4 descendants of its own.
- 2 other devices also cite its predicate K003235.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 POLYAX Locked Plating System is intended for use in cases requiring stabilization of malunions, non-unions, and osteotomies of the distal femur and proximal tibia and Open Reduction Internal Fixation (ORIF) repair of closed and open fractures of the distal femur and proximal tibia including, but not limited to the following: periarticular fractures, such as simple comminuted, lateral wedge, depression, medial wedge, bicondylar, combinations of lateral wedge and depression fractures with associated shaft fractures, and periprosthetic fractures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060969 · printed Nov 4, 2026
Cite this page
510(k) Report. “K060969: Polyax Locked Plating System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060969
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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