510(k) · Cleared
ClearedPelvis II Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Trauma AG · HRS Plate, Fixation, Bone
Cleared on May 31, 2013 as substantially equivalent to K001614 (Howmedica Osteonics Corp., 2000) after a 38-day review. Its family tree reaches back 1 generation to 2000. 5 later devices descend from it.
- Decided
- May 31, 2013
- Review
- 38 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K001614 (2000). 5 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK001614 Stryker Trauma Pelvic SetHowmedica Osteonics Corp. · 2000
- This deviceK131132 Pelvis II Implant SystemStryker Trauma AG · 2013
- 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 · 1 of its ownK223772 PRO Plating System, Stryker Trauma Pelvic Set (Matta)Stryker GmbH · 2023
- Descendant · 2 generations on · 0 of its ownK260958 I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius…I.T.S. GmbH · 2026
- Descendant · 2 generations on · 0 of its ownK260054 I.T.S. PRS Phoenix III.T.S. GmbH · 2026
- Descendant · 2 generations on · 0 of its ownK241666 EVOS Pelvic and Acetabular SystemSmith & Nephew · 2025
Most influential descendants
Showing 5 of 5 · See all- K210935I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)I.T.S. GmbH · 2022 · cites it directly3descendants
- K223772PRO Plating System, Stryker Trauma Pelvic Set (Matta)Stryker GmbH · 2023 · cites it directly1descendant
- K260958I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular…I.T.S. GmbH · 2026 · 2 generations on0descendants
- K260054I.T.S. PRS Phoenix III.T.S. GmbH · 2026 · 2 generations on0descendants
- K241666EVOS Pelvic and Acetabular SystemSmith & Nephew · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K001614 | Stryker Trauma Pelvic Set | Howmedica Osteonics Corp. | 2000 | — |
| 0 (this device) | K131132 | Pelvis II Implant System | Stryker Trauma AG | 2013 | — |
| +1 | K210935 | I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix) | I.T.S. GmbH | 2022 | 1 |
| +1 | K223772 | PRO Plating System, Stryker Trauma Pelvic Set (Matta) | Stryker GmbH | 2023 | — |
| +2 | K260958 | I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with… | I.T.S. GmbH | 2026 | — |
| +2 | K260054 | I.T.S. PRS Phoenix II | I.T.S. GmbH | 2026 | — |
| +2 | K241666 | EVOS Pelvic and Acetabular System | Smith & Nephew | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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? (1)
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 |
|---|---|---|---|
| * | K001614 | Stryker Trauma Pelvic Set | 2000 |
What descends from it? (5)
2 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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?
Indications for the Pelvis 11 implant System will include fractures of the following regions of the
pelvis ring:
* Anterior Column
* Anterior Column combined with posterior hemi-transverse
* Quadrilateral Surface
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131132 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131132: Pelvis II Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131132
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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