510(k) · Cleared
ClearedStryker Trauma Pelvic Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Howmedica Osteonics Corp. · KTW Appliance, Fixation, Nail/Blade/Plate Combination, Single Component
Cleared on Aug 4, 2000 after a 71-day review. The FDA summary names its predicate without a number. 12 later devices descend from it.
- Decided
- Aug 4, 2000
- Review
- 71 days
- Class
- Class II
- Product code
- KTW
- Recalls
- None
- Predicates
- 0
12 later devices descend from it, 5 citing it directly.
- This deviceK001614 Stryker Trauma Pelvic SetHowmedica Osteonics Corp. · 2000
- Descendant · cites it directly · 9 of its ownK063166 I.T.S. Pelvic Reconstruction SystemI.T.S. Implantat-Technologie-Systeme GmbH · 2006 · Recalled
- Descendant · cites it directly · 5 of its ownK131132 Pelvis II Implant SystemStryker Trauma AG · 2013
- 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 · 2 generations on · 3 of its ownK161894 SurgTech Trauma SystemSurgtech, Inc. · 2017
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K063166I.T.S. Pelvic Reconstruction SystemI.T.S. Implantat-Technologie-Systeme GmbH · 2006 · cites it directly9descendants
- K131132Pelvis II Implant SystemStryker Trauma AG · 2013 · cites it directly5descendants
- 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 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K001614 | Stryker Trauma Pelvic Set | Howmedica Osteonics Corp. | 2000 | — |
| +1 | K063166 | I.T.S. Pelvic Reconstruction System | I.T.S. Implantat-Technologie-Systeme GmbH | 2006 | 2 |
| +1 | K131132 | Pelvis II Implant System | Stryker Trauma AG | 2013 | — |
| +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 |
| +2 | K161894 | SurgTech Trauma System | Surgtech, Inc. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2017 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 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 KTW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | — | Synthes Pelvic Implant Set Named without a submission number |
What descends from it? (12)
See all 125 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?
- Of its descendants, K063166 (I.T.S. Implantat-Technologie-Systeme GmbH, 2006) has gone furthest, with 9 descendants of its own.
How does its category compare?
All KTW devicesKTW Appliance, Fixation, Nail/Blade/Plate Combination, Single Component: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KTW
1in 2019
2026 to Oct 25, outlined.
Median 510(k) review, days · KTW
Too few KTW 510(k)s in any year since 2007 to give a median.
Recalls per year · KTW
57in 2010
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KTW
96in 2025
MAUDE reports naming product code KTW, 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 | 0 | — | 0 | 3 |
| 2008 | 2 | — | 0 | 10 |
| 2009 | 0 | — | 0 | 2 |
| 2010 | 0 | — | 57 | 26 |
| 2011 | 0 | — | 0 | 21 |
| 2012 | 1 | — | 0 | 70 |
| 2013 | 0 | — | 0 | 70 |
| 2014 | 0 | — | 0 | 62 |
| 2015 | 0 | — | 0 | 26 |
| 2016 | 1 | — | 0 | 41 |
| 2017 | 2 | — | 0 | 27 |
| 2018 | 0 | — | 0 | 24 |
| 2019 | 1 | — | 0 | 11 |
| 2020 | 0 | — | 0 | 60 |
| 2021 | 0 | — | 0 | 25 |
| 2022 | 0 | — | 0 | 50 |
| 2023 | 0 | — | 0 | 30 |
| 2024 | 0 | — | 0 | 123 |
| 2025 | 0 | — | 0 | 96 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Stryker TraumaPelvic Set is indicated for:
Fractures of the acetabulum, sacrum, illium., and entire pelvic ring
Revision surgery of pseoduarthroses, non-unions and mal-unions
Osteonomies
Arthrodeses
Sacroihc joint dislocations
Symphysis pubis disruptures
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/K001614 · printed Nov 6, 2026
Cite this page
510(k) Report. “K001614: Stryker Trauma Pelvic Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K001614
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026