510(k) · Cleared
Recalled · Class II · 2026I.T.S. Pelvic Reconstruction System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
I.T.S. Implantat-Technologie-Systeme GmbH · HRS Plate, Fixation, Bone
Cleared on Dec 22, 2006 as substantially equivalent to K031573 (Synthes (Usa), 2003) and 5 other predicates after a 65-day review. Its family tree reaches back 8 generations to 1996. 9 later devices descend from it. It has been recalled 2 times.
- Decided
- Dec 22, 2006
- Review
- 65 days
- Class
- Class II
- Product code
- HRS
- Recalls
- 2
- Predicates
- 6
Its longest line of descent runs back 8 generations to K962616 (1996). 41 ancestors in all, the oldest K890939 (1989). 9 later devices descend from it, 6 citing it directly.
- Root · 8 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 7 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 6 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
- 5 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 4 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 3 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
- 2 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
- 1 generation backK060156 Straight Plate with Angular Stability & Screw SystemI.T.S. Implantat-Technologie-Systeme GmbH · 2006 · Recalled
- This deviceK063166 I.T.S. Pelvic Reconstruction SystemI.T.S. Implantat-Technologie-Systeme GmbH · 2006
- Descendant · cites it directly · 4 of its ownK122538 Acumed Pelvic Bone Plate SystemAcumed, LLC · 2012 · Recalled
- Descendant · cites it directly · 3 of its ownK210935 I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)I.T.S. GmbH · 2022 · Recalled
- Descendant · cites it directly · 3 of its ownK161894 SurgTech Trauma SystemSurgtech, Inc. · 2017
- Descendant · 2 generations on · 2 of its ownK242939 ARTFX Trauma Bone Plate and Screw SystemArtfx Medical · 2024
- Descendant · 3 generations on · 0 of its ownK261830 FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate…Ortler Global Tibbi Gerecler Anonim Sirketi · 2026
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K122538Acumed Pelvic Bone Plate SystemAcumed, LLC · 2012 · cites it directly4descendants
- K210935I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)I.T.S. GmbH · 2022 · cites it directly3descendants
- K161894SurgTech Trauma SystemSurgtech, Inc. · 2017 · cites it directly3descendants
- K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical · 2024 · 2 generations on2descendants
- K261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See…Ortler Global Tibbi Gerecler Anonim Sirketi · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −7 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −6 | K023007 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2002 | — |
| −5 | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −4 | K032705 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −3 | K050932 | Distal Volar Radius Anatomical Plate System | Hand Innovations, Inc. | 2005 | 1 |
| −2 | K051735 | Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity | Smith & Nephew, Inc. | 2005 | — |
| −1 | K060156 | Straight Plate with Angular Stability & Screw System | I.T.S. Implantat-Technologie-Systeme GmbH | 2006 | 2 |
| 0 (this device) | K063166 | I.T.S. Pelvic Reconstruction System | I.T.S. Implantat-Technologie-Systeme GmbH | 2006 | — |
| +1 | K122538 | Acumed Pelvic Bone Plate System | Acumed, LLC | 2012 | 1 |
| +1 | K210935 | I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix) | I.T.S. GmbH | 2022 | 1 |
| +1 | K161894 | SurgTech Trauma System | Surgtech, Inc. | 2017 | — |
| +2 | K242939 | ARTFX Trauma Bone Plate and Screw System | Artfx Medical | 2024 | — |
| +3 | K261830 | FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System… | Ortler Global Tibbi Gerecler Anonim Sirketi | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 8 | 0 |
| 2001 | 6 | 0 |
| 2003 | 2 | 0 |
| 2004 | 3 | 0 |
| 2005 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2017 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 4 | 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? (7)
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 |
|---|---|---|---|
| * | K031573 | Synthes 3.5 MM Low Profile Pelvic Reconstruction PlateSummary page 1…CE PRODUCT CODE: FIRS SUBSEQUENT PRODUCT CODE: JDW, FIWC, HTN SUBSTANTIALLY Synthes 3.5mm Low Profile Pelvic Reconstruction (K03 1573) EQUIVALENT DEVICES Stryker Trauma Pelvic Set (KOO]1614) Zimmer Pelvic Reconstruction Set… | 2003 |
| * | K001614 | Stryker Trauma Pelvic Set | 2000 |
| * | K001720 | Synthes Sacral Bar SystemSummary page 1…VALENT DEVICES Stryker Trauma Pelvic Set (KOO]1614) Zimmer Pelvic Reconstruction Set Synthes Sacral Bar System (1(001720) I.TS. GmbH FR.O.H. Calcaneus Repair System (K051642) Synthes 3.9mm Pelvic Scre… | 2000 |
| * | K051642 | FR.O.H. Calcaneus Repair SystemSummary page 1…Zimmer Pelvic Reconstruction Set Synthes Sacral Bar System (1(001720) I.TS. GmbH FR.O.H. Calcaneus Repair System (K051642) Synthes 3.9mm Pelvic Screw (K013044) I.TS. Straight Plate with Angular Stabili… | 2005 |
| * | K013044 | Synthes 3.9 MM Pelvic ScrewsSummary page 1…Synthes Sacral Bar System (1(001720) I.TS. GmbH FR.O.H. Calcaneus Repair System (K051642) Synthes 3.9mm Pelvic Screw (K013044) I.TS. Straight Plate with Angular Stability & Screw System (K060156) DEVICE DESCRIPTION: The ILT.… | 2001 |
| * | K060156 | Straight Plate with Angular Stability & Screw SystemSummary page 1…epair System (K051642) Synthes 3.9mm Pelvic Screw (K013044) I.TS. Straight Plate with Angular Stability & Screw System (K060156) DEVICE DESCRIPTION: The ILT.S. Pelvic Reconstruction System (PRS) encompasses a number of fractur… | 2006 |
| * | — | Zimmer Pelvic Reconstruction Set Named without a submission number |
What descends from it? (9)
6 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K122538 | Acumed Pelvic Bone Plate System | 2012 | 4 |
| K210935 | I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix) | 2022 | 3 |
| K161894 | SurgTech Trauma System | 2017 | 3 |
| K260958 | I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular… | 2026 | 0 |
| K260054 | I.T.S. PRS Phoenix II | 2026 | 0 |
| K241666 | EVOS Pelvic and Acetabular System | 2025 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 23, 2026 | Class II | Z-1600-2026 | No Marketing Application | Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU). |
| May 9, 2019 | Class II | Z-1718-2019 | Labeling mix-ups | The titanium implant has the wrong article number laser marked on it. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 10 years and passes through 5 companies; a new generation was cleared every 9 months on median.
- 12 of the 41 ancestors have a recall of any class.
- Of its descendants, K122538 (Acumed, LLC, 2012) has gone furthest, with 4 descendants of its own.
- 5 other devices also cite its predicate K031573.
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 intended use of the ITS. Pelvic Reconstruction System (PRS) is to stabilize one or more pelvic bone fractures in the 'pelvic ring' area of the pelvis of an adult or pediatric patient which include the use of the following pelvic fracture fixation systems. Indications for use of the ITS. PRS Low Profile - Multiple Type - Pelvic Plating System include: 1) Fracture reconstruction of the acetabulum, sacrum, illium, and entire pelvic ring, 2) Revision…
Read the full statement (209 words)
The intended use of the ITS. Pelvic Reconstruction System (PRS) is to stabilize one or more pelvic bone fractures in the 'pelvic ring' area of the pelvis of an adult or pediatric patient which include the use of the following pelvic fracture fixation systems.
Indications for use of the ITS. PRS Low Profile - Multiple Type - Pelvic Plating System include:
1) Fracture reconstruction of the acetabulum, sacrum, illium, and entire pelvic ring,
2) Revision surgery of pseoduarthroses, non-unions and mal-unions,
3) lio-Iliac distance osteosynthesis,
4) Osteotomies,
5) Arthrodesis,
6) Sacroiliac joint dislocations, and
7) Symphysis pubis disruptures
Indications far use of the I.T.S. PRS Sacral Rod System include:
1) Fixation of fractures of the posterior pelvis,
2) Fixation of fractures of the posterior iliac spine,
3) Fixation of fractures of the posterior inferior iliac spine,
4) Dorsal stabilization of the posterior pelvic ring for unstable pelvic ring injuries,
5) Fixation of sacral fractures, and
6) Fracture dislocations of the sacro-iliac joint
Indications for us of ethe ITS. PRS 7.3mm Cannulated SIJ Traction Screw & Washer includefaure f of pelvi fractures where indicated and for periacetabular osteotomies.
The system(s) has not been studied in spinal use, and is not intended for use in vertebral column fracture or fusion procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063166 · printed Nov 6, 2026
Cite this page
510(k) Report. “K063166: I.T.S. Pelvic Reconstruction System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063166
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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