510(k) · Cleared
ClearedSeries II X3 Large Diameter Accetabular Inserts
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Corporation · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Cleared on Nov 19, 2010 as substantially equivalent to K052748 (Howmedica Osteonics Corp., 2005) and 1 other predicate after a 28-day review. Its family tree reaches back 2 generations to 2000.
- Decided
- Nov 19, 2010
- Review
- 28 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K002575 (2000). 4 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K002575 | Inter-OP Durasul Acetabular Inserts (4MM) | Sulzer Orthopedics, Inc. | 2000 | — |
| −1 | K062419 | Trident Large Diameter Acetabular Inserts | Howmedica Osteonics Corp. | 2006 | — |
| 0 (this device) | K103124 | Series II X3 Large Diameter Accetabular Inserts | Stryker Corporation | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 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 LPH? 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 LPH device
- #1 K233498 Stryker Orthopaedics Hip Systems Labeling Updatescore 24.3 · 20 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 |
|---|---|---|---|
| * | K052748 | System 12 X3 Acetabular Inserts; Series II X3 Acetabular InsertsSummary page 2…line extension to address modifications made to the Series II X3' Acetabular Inserts. The modifications made to the previously cleared Series II X3® Acetabular Inserts (K052748) are as follows: new larger head sizes, an alternate 4mm lateralization (with 0 and 10 degree hood), and additional 0 degree hood… | 2005 |
| * | K062419 | Trident Large Diameter Acetabular InsertsSummary page 2…bular Inserts are substantially equivalent to the Series II X3®'Acetabular Inserts cleared under K052748 and Trident® X3® Large Diameter Acetabular Inserts cleared under K062419 in regards to intended use, design, materials, and operational principles as a hip prosthesis. Substantial Equiva… | 2006 |
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 10 years and passes through 3 companies; a new generation was cleared every 6.0 years on median.
- 1 of the 4 ancestors has a recall of any class.
How does its category compare?
All LPH devicesLPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · LPH
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LPH
153in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LPH
4in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LPH
6,163in 2025
MAUDE reports naming product code LPH, 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 | 10 | 116 | 16 | 509 |
| 2008 | 10 | 86 | 1 | 706 |
| 2009 | 3 | 112 | 2 | 1,156 |
| 2010 | 15 | 100 | 22 | 2,007 |
| 2011 | 16 | 110 | 26 | 3,320 |
| 2012 | 25 | 76 | 30 | 3,785 |
| 2013 | 11 | 135 | 9 | 5,002 |
| 2014 | 20 | 129 | 3 | 5,163 |
| 2015 | 18 | 111 | 1 | 5,830 |
| 2016 | 10 | 150 | 8 | 4,900 |
| 2017 | 12 | 121 | 14 | 5,312 |
| 2018 | 9 | 145 | 2 | 5,954 |
| 2019 | 22 | 164 | 8 | 7,130 |
| 2020 | 7 | 164 | 6 | 5,429 |
| 2021 | 8 | 410 | 4 | 5,978 |
| 2022 | 14 | 247 | 2 | 5,223 |
| 2023 | 10 | 111 | 2 | 5,345 |
| 2024 | 6 | 92 | 1 | 5,626 |
| 2025 | 12 | 153 | 4 | 6,163 |
| 2026 | 8 | 256 | 2 | — |
What is it indicated for?
The Series II X3® Large Diameter Acetabular Inserts are single use sterile components, intended for use in conjunction with an associated Howmedica Osteonics metal acetabular shell, femoral bearing, and femoral hip stem as part of a cemented or cementless total hip arthroplasty. The indications for use of total hip replacement prostheses include: 1) Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis…
Read the full statement (124 words)
The Series II X3® Large Diameter Acetabular Inserts are single use sterile components, intended for use in conjunction with an associated Howmedica Osteonics metal acetabular shell, femoral bearing, and femoral hip stem as part of a cemented or cementless total hip arthroplasty.
The indications for use of total hip replacement prostheses include:
1) Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis, or late stage avascular necrosis.
2) Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
3) Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
4) Where bone stock is of poor quality or inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103124 · printed Nov 3, 2026
Cite this page
510(k) Report. “K103124: Series II X3 Large Diameter Accetabular Inserts.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K103124
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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