510(k) · Cleared
ClearedI.T.S. PRS Phoenix II
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
I.T.S. GmbH · HRS Plate, Fixation, Bone
Cleared on Apr 24, 2026 as substantially equivalent to K210935 (I.T.S. GmbH, 2022) and 4 other predicates after a 106-day review. Its family tree reaches back 12 generations to 1996.
- Decided
- Apr 24, 2026
- Review
- 106 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 12 generations to K962616 (1996). 176 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 backK131722 I.T.S. Extremity Fixation SystemsI.T.S. GmbH · 2013 · Recalled
- 1 generation backK210935 I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)I.T.S. GmbH · 2022 · Recalled
- This deviceK260054 I.T.S. PRS Phoenix III.T.S. GmbH · 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 backK131722 I.T.S. Extremity Fixation SystemsI.T.S. GmbH · 2013 · Recalled
- 1 generation backK210935 I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)I.T.S. GmbH · 2022 · Recalled
- This deviceK260054 I.T.S. PRS Phoenix III.T.S. GmbH · 2026
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 | K131722 | I.T.S. Extremity Fixation Systems | I.T.S. GmbH | 2013 | 2 |
| −1 | K210935 | I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix) | I.T.S. GmbH | 2022 | 1 |
| 0 (this device) | K260054 | I.T.S. PRS Phoenix II | I.T.S. GmbH | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1981 | 1 | 0 |
| 1989 | 3 | 0 |
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1992 | 5 | 0 |
| 1993 | 3 | 0 |
| 1994 | 6 | 0 |
| 1995 | 6 | 0 |
| 1996 | 14 | 0 |
| 1997 | 3 | 0 |
| 1998 | 5 | 0 |
| 1999 | 8 | 0 |
| 2000 | 14 | 0 |
| 2001 | 14 | 0 |
| 2002 | 11 | 0 |
| 2003 | 6 | 0 |
| 2004 | 6 | 0 |
| 2005 | 14 | 0 |
| 2006 | 13 | 0 |
| 2007 | 7 | 0 |
| 2008 | 5 | 0 |
| 2009 | 5 | 0 |
| 2010 | 4 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 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? (5)
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 |
|---|---|---|---|
| * | K210935 | I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)Summary page 5…ODUCT CODE: HRS SUBSEQUENT PRODUCT CODE : HTN, HWC SUBSTANTIAL EQUIVALENCE: PRIMARY PREDICATE I. T.S. Pelvic Reconstruction System PRS RX & PRS Phoenix (K210935) ADDITIONAL PREDICATES I.T.S. Pelvic Reconstruction System (K063166) Stryker PRO Plating System, Str… | 2022 |
| * | K063166 | I.T.S. Pelvic Reconstruction SystemSummary page 5…EQUIVALENCE: PRIMARY PREDICATE I. T.S. Pelvic Reconstruction System PRS RX & PRS Phoenix (K210935) ADDITIONAL PREDICATES I.T.S. Pelvic Reconstruction System (K063166) Stryker PRO Plating System, Stryker Trauma Pelvic Set (Matta) (K223772) DePuy… | 2006 |
| * | K223772 | PRO Plating System, Stryker Trauma Pelvic Set (Matta)Summary page 5…(K210935) ADDITIONAL PREDICATES I.T.S. Pelvic Reconstruction System (K063166) Stryker PRO Plating System, Stryker Trauma Pelvic Set (Matta) (K223772) DePuy Synthes 3.5mm Intrapelvic Acetabular System (K221809) Acumed Pelvic Bone… | 2023 |
| * | K221809 | DePuy Synthes 3.5mm Intrapelvic Acetabular SystemSummary page 5…Stryker PRO Plating System, Stryker Trauma Pelvic Set (Matta) (K223772) DePuy Synthes 3.5mm Intrapelvic Acetabular System (K221809) Acumed Pelvic Bone Plate System (K122538) DEVICE DESCRIPTION: The I.T.S. PRS Phoenix II consists… | 2022 |
| * | K122538 | Acumed Pelvic Bone Plate SystemSummary page 5…lvic Set (Matta) (K223772) DePuy Synthes 3.5mm Intrapelvic Acetabular System (K221809) Acumed Pelvic Bone Plate System (K122538) DEVICE DESCRIPTION: The I.T.S. PRS Phoenix II consists of the following implants: o Symphysis… | 2012 |
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 30 years and passes through 5 companies; a new generation was cleared every 2.1 years on median.
- 33 of the 176 ancestors have a recall of any class.
- 2 other devices also cite its predicate K210935.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 I.T.S. PRS Phoenix II is indicated to stabilize one or more pelvic bone fractures in the pelvis in an adult patient. Indications for use of the I.T.S. PRS Phoenix II include: • Symphyseal Disruptions & Parasymphyseal Fractures • Disruptions of the Sacroiliac Joint • Fractures involving the Anterior Column of the Acetabulum • Fractures involving the Quadrilateral Surface • Fractures involving the Posterior Wall • Fractures involving the Posterior…
Read the full statement (115 words)
The I.T.S. PRS Phoenix II is indicated to stabilize one or more pelvic bone fractures in the pelvis in an adult patient. Indications for use of the I.T.S. PRS Phoenix II include:
• Symphyseal Disruptions & Parasymphyseal Fractures
• Disruptions of the Sacroiliac Joint
• Fractures involving the Anterior Column of the Acetabulum
• Fractures involving the Quadrilateral Surface
• Fractures involving the Posterior Wall
• Fractures involving the Posterior Column
• Dorsal neutralization plating for Posterior Pelvic Ring Fractures
• Fractures of the Acetabulum, Fractures of the Pelvic Ring, Fractures of the Ilium
• Fracture Revision surgery of pseudoarthrosis, non-unions and mal-unions
The I.T.S. PRS Phoenix II System is not intended for spinal use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K260054 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260054: I.T.S. PRS Phoenix II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260054
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026